Nationality: Algerian/ Canadian/French

Qualifications:
• Pharmacy degree and PhD in Pharmacology – University of Algiers
• Master’s in biomedical pharmacy – Paris Descartes University
• Master’s in Pharmacovigilance & Drug Safety – Paris Descartes University
• Certification in Global Health focusing on Quality & Safety – Harvard T.H. Chan School

Professional experience:
• Lecturer in Pharmacology, Universities of Algiers, Versailles, and Essen (2004–2025)
• Pharmacovigilance Officer, Regional Centre Paris – ANSM Network (2008–2010)
• Senior Pharmacist, Georges Pompidou Hospital Paris – Quality & Risk Management (2011–2017)
• Drug & Device Safety Lead, Sanofi Canada (2017–2021)
• Founder & Director, InnoVigilance International Academy, Montreal (2020–2025)
• Safety Officer, Pfizer Canada (2021–2022)
• 25+ years in pharmacovigilance, including 12 years in quality assurance and risk management
• Extensive international experience across academia, regulatory agencies, and industry

Professional experience in committee posts:
• ISoP member, FISoP; Executive Committee Member and Treasurer (2020-2025)
• President, North American Chapter (NASoP); Lead, ISoP Medical Device Safety SIG (2021-2025)
• Chair, Local Organizing Committee – ISoP 2024 Annual Meeting, Montreal (2024)
• Chair, Organizing & Scientific Committee – ISoP Boston Seminar (2025)
• Chair, NASoP Election Committee (2021)
• Former Vice-President, ASPROPHARM (Pharmacists’ Association – Paris, France)

Your vision for pharmacovigilance:
• Reposition pharmacovigilance as a scientific and public health driver of global innovation
• Place members at ISoP’s core by advancing engagement, inclusivity, and leadership development
• Enhance cross-collaboration among Chapters, SIGs, and Working Groups
• Expand training and certification to build global capacity and elevate professional standards
• Ensure transparent governance and financial sustainability aligned with strategic priorities

Reasons for standing for election and what you can you do for ISoP:
I am standing for election to bring the breadth of my global experience to support the Advisory Board in
strengthening ISoP’s collective impact on patient safety worldwide.
As an ISoP Executive Committee member, Medical Device Safety SIG lead, and President of the North
American Chapter, I have contributed to advancing ISoP’s mission through collaboration, innovation, and
strategic thinking.
With a strong academic background, scientific publications, and global speaking engagements, I bring a
perspective grounded in science, public health, and international engagement.
If elected, I will work closely with fellow AB members to reposition pharmacovigilance as a core scientific
discipline that serves public health and protects patients.
Together, we can foster inclusive leadership, expand capacity-building, strengthen governance, and
enhance member engagement to advance ISoP’s long-term vision.

Nationality: Iranian

Qualifications:
Doctor of Pharmacy (Pharm.D.), Shahid Beheshti University of Medical Sciences, Tehran, Iran
PhD in Clinical Pharmacy (Pharmacotherapy), Tehran University of Medical Sciences, Tehran, Iran
MBA in Pharmaceutical Management, Tehran University of Medical Sciences, Tehran, Iran
Master of Public Health (MPH), Iran University of Medical Sciences, Tehran, Iran (in progress)
Multiple international certificates in pharmacovigilance, clinical trials, and drug safety

Professional experience:
Medical Science Consultant, Orchid Pharmed, Tehran (2023–Present): Leading scientific and medical support for pharmaceutical products, clinical data analysis, and educational program development
Pharmacovigilance Officer, Actero Pharma, Tehran (2019–2022): Managed adverse event reporting, safety data analysis, and regulatory submissions
Clinical Pharmacist, Ministry of Health and Medical Education, Iran (2017–2019): Developed national drug prescription guidelines and conducted medication safety reviews
Lecturer and Researcher in Clinical Pharmacy (2016–Present): Taught pharmacotherapy courses and supervised clinical research projects

Professional experience in committee posts:
ISoP Member (since 2022): Active participation in annual and mid-year meetings, contributing to global pharmacovigilance discussions/Committee Member, Iranian Society of Clinical Pharmacy: Involved in educational and scientific program development/Contributor, National Drug Prescription Guideline Committee, Ministry of Health: Supported policy and guideline development/Internal Committees, Orchid Pharmed and Actero Pharma: Led pharmacovigilance training and cross-functional medical strategy meetings

Your vision for pharmacovigilance:
My vision is to position Iran as an active, innovative participant in global pharmacovigilance.
I aim to bridge the gap between international best practices and national policy, ensuring patient safety through data-driven approaches. Collaboration and transparent data sharing are essential for advancing drug safety. Empowering healthcare professionals and policymakers with education and real-world evidence is key. By fostering international partnerships, we can elevate pharmacovigilance standards in Iran and the region.

Reasons for standing for election and what you can you do for ISoP:
Iran currently has no formal collaboration with ISoP, offering a unique opportunity to build a strong partnership. By leveraging my network with Iran’s FDA policymakers and expertise in drug safety, I can help facilitate knowledge exchange. Supporting alignment of Iran’s pharmacovigilance systems with global standards will improve national drug safety. Acting as a bridge, I aim to promote data sharing and joint projects involving key stakeholders on both sides. Raising awareness of ISoP’s mission will help build capacity among Iranian healthcare and regulatory professionals. My experience in policy and education can support advocacy for evidence-based pharmacovigilance improvements. I will work to identify local challenges and integrate international best practices tailored to Iran’s needs. Organizing workshops, research collaborations, and policy dialogues will foster a culture of safety and transparency. Through collaboration and dedication, I hope to expand ISoP’s positive impact in Iran and globally.

Nationality: Moroccan

Qualifications:
Pharmacist at the centre Anti poison et de pharmacovigilance du maroc (CAPM), Rabat Collaborating Center.

Professional experience:
I’m a pharmacist, trained at the School of Pharmacy in Monastir, Tunisia.
I joined the Moroccan Poison Control and Pharmacovigilance Centre (CAPM) in 2001
Since then, I’ve been fully dedicated to patient safety, from promoting safe use of medicines to preventing medication errors and working on risk minimization. I’ve had the opportunity to collaborate with WHO, the World Alliance for Patient Safety, the Uppsala Monitoring Centre, and others, to help strengthening the role of pharmacovigilance centres around the world.
Since 2011, I’ve also been involved with WHO and the Rabat Collaborating Centre in building capacity in pharmacovigilance and vaccine safety, especially across French-speaking African countries and the Eastern Mediterranean region.

Professional experience in committee posts:
Over the past two decades, I’ve been deeply involved in the organization of major pharmacovigilance events at national, regional, and international levels. From co-organizing the ISoP 2003 Annual Meeting in Marrakech and leading the first Arab/EMR PV meeting in Rabat, to coordinating the 15th IMSN meeting and several WHO and ISoP scientific committees. I have also led regional initiatives like the EMR COVID-19 vaccine PV network (RAN) and co-developed training courses on medication errors with UMC. Since 2022, I have been member of the ISoP Advisory Board, where I currently act as Academic Coordinator.

Your vision for pharmacovigilance:
Pharmacovigilance should be accessible, efficient, and meaningful for all countries.
The COVID-19 pandemic taught us that the development of pharmacovigilance must happen at the same time and at the same speed everywhere, so that all countries can ensure patient safety. We need to build systems that allow every country to monitor all health products, based on common standards and timelines. This means working together through work-sharing and regulatory reliance and focusing on a more proactive and collaborative approach to safety.

Reasons for standing for election and what you can you do for ISoP:
Being part of the ISoP Advisory Board these past three years has been an incredible journey, full of learning, meaningful sharing, and generous exchanges. This time allowed me to understand ISoP from the inside, to listen to its members, and to better understand how we can serve our community with purpose.
These three years were not an end in themselves, but a necessary step to prepare for the next chapter,
to give back even more, with clarity, commitment, and renewed energy.
Since 2002, ISoP has been a constant in my professional life, through presentations, training sessions, and international collaborations. I co-organized ISoP 2003, contributed to several conferences, and joined several scientific committees since 2022.
With over 20 years of experience in development of pharmacovigilance systems, I would be honored to continue supporting ISoP’s mission to make pharmacovigilance stronger and accessible to all countries.

Nationality: Indian

Qualifications:
MBBS, DTM&H, MD, FRCP (London)

Professional experience:
I am a medical pharmacologist currently serving as a faculty for the last 25 years in the Institute of Postgraduate Medical Education & Research, Kolkata, a pioneer medical college and hospital in eastern India. Besides postgraduate and undergraduate medical teaching, I am also a practicing clinician. I shoulder additional responsibilities of the chief coordinator of the East zone regional training centre on ADR monitoring and training for the last 15 years. I hold the chair of the Core Training Panel of the Pharmacovigilance Program of India and serve as member of the Signal review panels both for vacines and medicines under the Govt of India. I have been serving as an expert for two WHO committees: INN Programme and the Committee for specification of pharmaceutical standards at Geneva. I have over 90 publications in peer reviewed journals and authored several book chapters/ PV related guidance documents. I have conducted several research projects on pharmacovigilance and pharmacogenomics.
Professional experience in committee posts:
1. Chairperson of the Core Training Panel, Pharmacovigilance Program of India, (PVPI), Ministry of Health & Family Welfare, Government of India since June 2023.
2. Member of the Signal Review Panel for Adverse Events following Immunization, Ministry of Health & Family Welfare, Govt of India, since November 2021.
3. Member of the Signal Review Panel, Pharmacovigilance Program of India, (PVPI), Ministry of Health & Family Welfare, Govt of India since 2014.
4. Independent member of the National Adverse Event following Immunization (AEFI) Committee, Govt of India, Ministry of Health & Family Welfare, since April 2017.
5. Chief Coordinator, Training and Technical Support of Eastern Regional Resource Centre of the Pharmacovigilance Program of India (PVPI), Govt of India since 2011.
6. Member, Sentinel Surveillance System for Adverse Events of special Interest (SSSAESI) following Covid vaccination- Technical advisory Group, Ministry of Health & Family Welfare, Govt of India, since June 2021
7. Nominated Expert of the WHO International Non proprietary name (INN) Programme, Geneva, since September 2020.
8. Nominated Expert of the WHO Committee for specification of pharmaceutical standards, Geneva, since August 2022.

Your vision for pharmacovigilance:
1. Empower the common man and foster patient centric approach for monitoring and preventing medication related harm and protect public health.
2. Enabling more evidence based decision making for all stakeholders globally involved in pharmacovigilance
3. Hand holding to strengthen resource limited nations in pharmacovigilance activities

Reasons for standing for election and what you can you do for ISoP:
I am seeking election to the advisory committee to contribute my extensive experience in pharmacovigilance to foster and strengthen international collaboration. My goal is to advance ISOP’s mission by providing strategic guidance that strengthens medication monitoring and protects public health worldwide. I would like to offer my long standing teaching and research experience to assist the existing ISOP team to develop more online educational and teaching programs/courses in PV for HCP of low and middle income countries based on their priority needs and undertake more clinical research activities. Serving as a WHO expert, I look forward to contributing towards furthering alliances and building networks with healthcare professionals mainly physicians in SE Asian region. Furthermore, I would like to encourage young healthcare professionals to join ISOP which serves as an excellent global platform to work together for the common cause of medication safety.

Nationality: Italian

Qualifications:
1. Master’s Degree in Pharmaceutical Chemistry and Technology (University of Messina, Messina,
Italy). Final mark: 110/110 cum laude
2. Second-cycle Master’s Degree in “Pharmacovigilance, pharmacoepidemiology,
pharmacoeconomics: evaluations using real-world data” (University of Messina, Messina, Italy).
Final mark: 110/110 cum laude
3. Post-graduate degree in Clinical Pharmacology and Toxicology (University of Messina, Messina,
Italy). Final mark: 50/50 cum laude
4. PhD in Clinical and Experimental Biomedical Sciences (University of Verona, Verona, Italy).

I am a pharmacist, clinical pharmacologist, and researcher in the fields of pharmacovigilance,
pharmacoepidemiology and real-world data analysis. I have been actively involved in designing and
conducting real-world studies aimed at evaluating the safety and efficacy of pharmaceutical agents, with a
particular focus on rare diseases and orphan drugs. Additionally, I support in coordinating activities related
to the scientific peer-reviewed journal Frontiers in Drug Safety and Regulation. I also serve as an adjunct
professor at the University of Verona, where I teach Pharmacology in the Bachelor’s degree program in
Nursing.

Professional experience:
Academic professional experiences:
1. Research assistant in Pharmacovigilance and Pharmacoepidemiology (University of Messina,
Messina, Italy)
2. PhD Student in Clinical and Experimental Biomedical Sciences (University of Verona, Verona, Italy)
3. Visiting research trainee at the Division of Pharmacoepidemiology and Pharmacoeconomics,
Brigham & Women’s Hospital and Harvard Medical School (Boston, Massachusetts)
4. Postdoctoral researcher in Pharmacovigilance and Pharmacoepidemiology (University of Verona,
Verona, Italy)
5. Adjunct professor of Pharmacology at the bachelor’s degree in nursing (University of Verona,
Verona, Italy)

Since April 2023, I serve as Treasurer of the ISoP Italian Chapter, contributing to the coordination of local
initiatives. As member of the ISoP Italian Chapter, I was also involved in the publication of a narrative review
on the conduction and interpretation of disproportionality analyses in pharmacovigilance:
• Cutroneo P, Sartori D, Tuccori M, Crisafulli S, Battini V, Carnovale C, Rafaniello C, Capuano A,
Poluzzi E, Moretti U, Raschi E. Conducting and interpreting disproportionality analyses derived
from spontaneous reporting systems. (2024) Frontiers in Drug Safety and Regulation, 3:1323057

Moreover, I am currently contributing to the coordination of the ISoP Special Interest Group on Real-World
Evidence and Big Data. Through this role, I have helped promote methodological dialogue, organize
scientific webinars, and support the uptake of real-world evidence within pharmacovigilance frameworks.
A significant milestone of my engagement in the activities of this Special Interest Group was coordinating
the development and drafting of the following paper:
• Crisafulli S, Bate A, Brown JS, Candore G, Chandler RE, Hammad TA, Lane S, Maro JC, Norén GN,
Pariente A, Russom M, Salas M, Segec A, Shakir S, Spini A, Toh S, Tuccori M, van Puijenbroek E,
Trifirò G; Real-World Evidence and Big Data Special Interest Group of the International Society of
Pharmacovigilance. Interplay of Spontaneous Reporting and Longitudinal Healthcare Databases
for Signal Management: Position Statement from the Real-World Evidence and Big Data Special
Interest Group of the International Society of Pharmacovigilance, Drug Safety
(https://doi.org/10.1007/s40264-025-01548-3).

I was also involved in the development of the READUS-PV guidelines for the reporting of disproportionality
analyses for drug safety signal detection using individual case safety reports in pharmacovigilance:
• Fusaroli M, Salvo F, Begaud B, AlShammari TM, Bate A, Battini V, Brueckner A, Candore G,
Carnovale C, Crisafulli S, Cutroneo PM, Dolladille C, Drici MD, Faillie JL, Goldman A, Hauben M,
Herdeiro MT, Mahaux O, Manlik K, Montastruc F, Noguchi Y, Norén GN, Noseda R, Onakpoya IJ,
Pariente A, Poluzzi E, Salem M, Sartori D, Trinh NTH, Tuccori M, van Hunsel F, van Puijenbroek E,
Raschi E, Khouri C. The REporting of A Disproportionality analysis for drUg Safety signal detection
using individual case safety reports in PharmacoVigilance (READUS-PV): explanation and
elaboration. (2024). Drug Safety. 47(6), 585–599. https://doi.org/10.1007/s40264-024-01423-7

• Fusaroli M, Salvo F, Begaud B, AlShammari TM, Bate A, Battini V, Brueckner A, Candore G,
Carnovale C, Crisafulli S, Cutroneo PM, Dolladille C, Drici MD, Faillie JL, Goldman A, Hauben M,
Herdeiro MT, Mahaux O, Manlik K, Montastruc F, Noguchi Y, Norén GN, Noseda R, Onakpoya IJ,
Pariente A, Poluzzi E, Salem M, Sartori D, Trinh NTH, Tuccori M, van Hunsel F, van Puijenbroek E,
Raschi E, Khouri C. The REporting of A Disproportionality analysis for drUg Safety signal detection
using individual case safety reports in PharmacoVigilance (READUS-PV): development and
statement. (2024). Drug Safety. 47(6), 575–584. https://doi.org/10.1007/s40264-024-01421-9

Professional experience in committee posts:
Since April 2023, I am the treasurer of the ISoP Italian Chapter.
Member of the local organizing committee of the 21st ISoP Annual Meeting: “A New Era of
Pharmacovigilance: Challenges and Opportunities” – 20-23 September 2022, Verona, Italy.

Your vision for pharmacovigilance:
As an academic pharmacologist, I envision pharmacovigilance as a dynamic bridge between science and
public health, integrating cutting-edge research, real-world data, digital innovation, and critical thinking to enhance risk assessment. Fostering interdisciplinary collaboration and training future experts are key to
advancing a globally responsive, evidence-based system.

Reasons for standing for election and what you can you do for ISoP:
I am standing for the ISoP Advisory Board for the 2025 election to contribute my academic and scientific
experience to ISoP’s global mission. As a pharmacologist engaged in research, I strongly believe in the
essential role of evidence-based pharmacovigilance and the need to connect science with practice. I aim to promote interdisciplinary collaboration, strengthen scientific communication, and support education and training initiatives, especially for early-career professionals. I am committed to fostering inclusive dialogue across regions and healthcare systems, helping ISoP expand its impact as a global, diverse, and dynamic network. I also hope to contribute to the strategic use of real-world data, emerging technologies, and academic partnerships to advance drug safety and patient care.

Nationality: Canadian/Lebanese

Qualifications:
EDUCATION
• Medication Safety Fellowship (Institute for Safe Medication Practices)
• Masters of Arts in Communication (Johns Hopkins University)
• Doctorate of Pharmacy (Lebanese American University)
• Post-Graduate Year Two (PGY-2) Pediatric Pharmacy Residency (Peyton Manning Children’s Hospital)
• Post-Graduate Year One (PGY-1) Pharmacy Residency (St. Michael’s Medication Center)
CERTIFICATION
• Certified Professional in Human Factors in Healthcare (CPHFH)
• Certified Professional In Healthcare Quality (CPHQ)
• Certified Professional in Patient Safety (CPPS)

Professional experience:
• Senior Manager, Quality and Medication Safety Services (Cleveland Clinic Abu Dhabi, UAE)
• Medication Safety Pharmacist (Health Sciences North, Canada)
• Clinical Assistant Professor (Lebanese American University)

Professional experience in committee posts:
• Department of Health Medication Safety Committee (Member, Department of Health, UAE)
• Quality & Medication Safety Committee (Chair, Cleveland Clinic Abu Dhabi)
• Quality & Patient Safety Council (Member, Cleveland Clinic Abu Dhabi)

ISoP Committee Membership
• Communications Team (Member)
• Medication Safety Special Interest Group (Member)
• North America Chapter (Recent member, no active involvement yet)
• Middle East Chapter (Recent member, no active involvement yet)

Your vision for pharmacovigilance:
My vision is to embed human factors at the core of pharmacovigilance globally, ensuring it informs every stage of medication use and safety. Equally, I envision integrating the art and science of communication as a strategic tool making the transmission of safety signals more timely, clear, and actionable thus allowing for more effective decision-making across the health system.

Reasons for standing for election and what you can you do for ISoP:
I am standing for election to the ISoP Board to bring my deep passion for human factors and communication, two critical yet often underutilized dimensions of pharmacovigilance. With extensive experience applying both in the context of medication error prevention, I’ve seen how thoughtful system design and effective communication can transform safety outcomes.
I’m committed to working collaboratively with fellow board members to shape a bold, modern communication strategy that reaches regulators, practitioners, and the public with clarity and impact. Equally, I will focus on strengthening the knowledge and skills of our members through targeted training and shared learning in these key areas.
My vision is to help ISoP lead globally in preventing errors through smarter systems, stronger communication, and collective action.

Nationality: Indian

Qualifications:
B.Pharma

Professional experience:
1. Founder & Lead PV /GxP Consultant
2. Regional PVQA Director (Asia Pac) Johnson & Johnson
3. Sr. PV Manager, Dr. Reddy’s Lab India
4. Affiliate PV Head, Sanofi Aventis India
5. Manager Pharmaceutical Operations, Aventis India

Professional experience in committee posts:
1. CEO – PVCON Consulting – 15 yrs
2. DIA India Chair for PV Conferences – 12 yrs
3. Trainer to CDSCO /DCG of India – 10 yrs
4. Adjunct Prof. Jamia Hamdard – 5 yrs and ongoing
5. ISoP S Asia Chapter Lead – ~ 5 yrs
6. Consultant to BoMRA (Botswana) – 2 yrs and ongoing

Your vision for pharmacovigilance:
My vision for pharmacovigilance is driven by my passion for patients’ safety and well being. I look forward to a situation where the ADR reporting rates in India & other developed Asian countries to be as good as their European counterparts. Even this could be a herculean task, my vision would be to minimize ADRs occurrence in this region, through educating & sensitizing HCPs about ‘Drug Safety’ in a manner that drugs are prescribed rationally and base on correct medical acumen.

Reasons for standing for election and what you can you do for ISoP:
As the AB member representing the largest continent Asia, I think, I would be in best position to know and evaluate emerging safety issues and public health problems in this territory and keep the AB appraised accordingly. As a responsible AB representative of ISoP, I would be in a position of strength to liaise with local Regulatory Agencies in this part of the world, compile valuable inputs for ISoP while simultaneously monitoring and pushing ISoP driven initiatives in this region.
As its well known fact that the PV awareness among public, HCPs, Institutions, is at the lowest ebb, I foresee a very important role for myself as mentor & trainer. My association with PV Program of India would be further enhanced in the new role.
I have been promoting ISoP SIG (Students Chapter) in various institutions in India, and in the capacity of the AB member, I would have more , contribution visibility within ISoP ensuring greater support for such activities.

Nationality: UK

Qualifications:
BSc MB BS MRCS MD MRCP FISOP
Fellow of International Society of Pharmacovigilance

Professional experience:
Hospital Medicine 1980-1988
Clinical research: Lecturer in Medicine attached to Renal Unit University of Manchester 1988-1994
Senior Medical Assessor Pharmacovigilance Assessment Group, Medicines Control Agency 1994-1999
Senior Medical Director Parexel International 1999-2005
Deputy qualified person for pharmacovigilance Johnson & Johnson 2005-2007
Principal consultant NDA Regulatory Science Ltd 2007-2021
Managing Director, Husoteria Ltd 2021- present day

Professional experience in committee posts:
Chair panel convenors overseeing Drug Safety Surveillance module as part of pharmaceutical specialist training on behalf of UK Faculty of Pharmaceutical Medicine
Founding member and previously part of the planning committee for the DIA ‘QPPV forum’: currently the only international association for QPPVs, and deputy QPPVs
Previously Treasurer of ISoP and Executive Committee and Advisory Board Member during the period 2002-2019 (allowing for a three-year gap); previously ISOP Chapter coordinator
Chair Scientific Committee ISOP 2010 and 2019; ISoP representative organizing committee 2017
Co-chair ISOP Medication Errors Special Interest Group
Chair of the Pharmaceutical Ergonomics & Human Factors Group as part of the Chartered Institute of Ergonomics & Human Factors
Currently Vice-President ISOP and Director ISoP Secretariat Ltd
Previously Co-chair DIA SIAC Clinical Safety and Pharmacovigilance 2002-2008.

Your vision for pharmacovigilance:
Pharmacovigilance continues to evolve to meet new challenges such as how best to involve patients and families in the system and integrate new technologies such as machine learning, AI and pharmacogenomics into our processes to maximize benefits for both users and patients. We must also strive to be environmentally sustainable as well as ensure we design and develop processes with humans at the centre.

Reasons for standing for election and what you can you do for ISoP:
1) In my previous roles as Vice-President, Treasurer and Executive Committee Member of ISoP, I have demonstrated the ability and willingness to develop ISoP. From my previous and current ISOP roles, I have insight into how Annual meetings can be set up, the operation of the chapters, successfully led the Medication Errors SIG and initiated new groups.
2) Since 2004, I have been actively involved in developing pharmaceutical safety culture with a view to ISoP having a central leadership role. As a Board Member I can contribute to the design and delivery of progressive and innovative training programs and implementation of the competency framework
3) I have over 30 years’ worth of experience of pharmacovigilance with experience of the regulatory, contract research, industry, and consulting sectors. In addition, my past background of hospital medicine and clinical research means I am well qualified to identify with many of the key stakeholders in pharmacovigilance who are members of ISoP. This means I am well placed to meet their needs and advise what is appropriate training and development for them.
4) My long career in pharmacovigilance means I am well connected globally so that I am well placed to spread the ISoP messages around safe and effective us of medicines about which ISoP feels so strongly.

Nationality: United States of America

Qualifications:
MD, PhD, MSc, MS, FISPE

Professional experience:
I currently serve as the Vice President and Head of Medical Safety for Marketed Products Development, Plasma-Derived Therapies, and Medical Device Safety at Takeda Pharmaceuticals. Prior to this role, I held senior leadership positions at several leading companies, including Sanofi, Merck KGaA, and US Merck. Before transitioning to industry, I spent 13 years at the US FDA, where I progressively took on greater responsibilities, ultimately serving as Deputy Division Director at a division in the Office of Surveillance and Epidemiology, CDER. At the FDA, I was honored with several prestigious awards, including the FDA Distinguished Service Award and the Frances Kelsey Excellence in Drug Safety Award. I have contributed to scientific advancement in pharmacovigilance (PV) through teaching, publishing, peer reviewing for major scientific journals, and participating in public-private consortia such as the Innovative Medicines Initiative (IMI) and the Council for International Organizations of Medical Sciences (CIOMS). I also served as a member of the ICH Expert Working Group for the M4E(R2) guideline on enhancing the format and structure of benefit-risk information. My work has been recognized both nationally and internationally, and I am regularly invited to speak at webinars, scientific conferences, symposia, and public workshops. I have also served as a session chair and member of scientific program committees in several conferences. In addition to my professional responsibilities, I have held various academic appointments and authored over 80 peer-reviewed articles, letters to the editor, and book chapters. For additional details, please visit www.DrTarekHammad.com.

Professional experience in committee posts:
As an engaged ISoP member and active contributor to the North America Chapter (NASoP), I served on the Scientific Committee for the successful 2024 ISoP Annual Meeting. I also actively contribute to several of the Society’s committees and Special Interest Groups, including the ISoP Real-World Evidence (RWE) and Big Data SIG. In parallel, I serve as Co-Chair of the American Statistical Association’s (ASA) Safety Scientific Working Group, where I help advance interdisciplinary dialogue and methodological innovation in safety science. I am also a Fellow of ISPE and currently Chair of ISPE’s Industry Council, a role that enables me to foster strategic cross-sector collaboration and support the society’s mission globally. Additionally, I serve on the Program Committee for the Annual DIA Global Pharmacovigilance Conference, where I contribute to shaping the scientific agenda and ensuring the conference remains a leading forum for advancing regulatory and scientific perspectives in PV.

Your vision for pharmacovigilance:
PV is at the heart of regulatory decision-making, guiding benefit-risk conversations with clear, transparent communication to all stakeholders. I envision a PV landscape driven by emerging technologies, real-world evidence and pragmatic, data-driven risk assessment, where safety signals are identified early and managed decisively. A truly global, collaborative network of stakeholders—spanning industry, regulators, academia, and patients—will share insights across various regions, harmonize methods, and accelerate innovation. Upholding scientific independence, we will safeguard public trust by ensuring that safety science remains unbiased and focused squarely on patient welfare. Finally, we will nurture the next generation of safety leaders, equipping them with the skills, mentorship, and inclusive culture needed to advance public health worldwide.

Reasons for standing for election and what you can you do for ISoP:
I am honored to be nominated for the ISoP Advisory Board and bring over three decades of experience across regulatory, industry, and academic settings—including leadership roles at the FDA, Merck, Sanofi, and Takeda. My career has been dedicated to advancing PV, from establishing the FDA’s first intramural drug-safety research program to leading global integration of evidence-based medicine approaches into safety causality assessments. If elected, I will focus on advancing scientific innovation and expanding ISoP’s visibility and impact—particularly through thought leadership in PV and benefit-risk methodologies, real-world evidence, and digital safety tools. I will leverage my international network and experience on global committees to strengthen ISoP’s role as a cross-sector convenor and ensure that its guidance influences policy and practice worldwide. I am committed to safeguarding ISoP’s scientific independence by promoting transparency, upholding unbiased discourse, and reinforcing its position as a trusted, non-commercial voice in patient safety. I will also support the development of early-career professionals through continuing my mentoring activities and championing an inclusive environment that welcomes diverse perspectives.

Nationality: Serbia/ USA

Qualifications:
Medical Doctor, Masters Pharmacology, PhD Pharmacology; MPH 1) Epidemiology 2) Clinical Research;
Internal Medicine & Clinical Pharmacology Fellowship; Epidemiology Fellowship; Drug Research & Development
Fellowship.

Professional experience:
Industry Experience: 2014-2025
Executive (Head of Drug Safety and Risk Management): Celldex Therapeutics, Raptor Pharmaceuticals
Sr. Director Pharmacovigilance and Risk Management, Exelixis
Senior Medical Director, Clinical Pharmacology/ Clinical Science: Takeda Pharmaceuticals; Shire (acquired by
Takeda)
Consulting Experience: 2010-Present
Various companies; Degge Group Ltd (acquired by PharmaLex in 2017), Bridge to Data
The Pharmaceutical Education & Research Institute (PERI)
National Expert, Medicines and Medical Devices Agency of Serbia 2002-14
Academic and Editorial Experience:
Professor, Head of Department of Pharmacology, Trinity School of Medicine, St. Vincent and Grenadines
Associate Professor, Dept. of Pharmacology, School of Pharmacy, University of Belgrade
Clinical Therapeutics, Topic Editor, Pharmacovigilance 8/2022-Present

Professional experience in committee posts:
-International Society of Pharmacovigilance (ISoP)
ISoP Scientific Board Member, 2022-24, Fellow of ISoP (2019)
ISoP Communication Lead, 01/2021-12/22;
Scientific Committee Member: ISoP Annual Meeting, Montreal, 2024; Bogota, Colombia, 2019
Chair of the Poster Price Committee, Bali, Indonesia, 2023.
Founder and Coordinator of the South-Eastern European (SEE) ISoP Chapter, 2012-24
Chaired 6 ISoP training courses/symposiums at the ISoP Annual meetings; ISoP speaker and abstract reviewer.
Manuscripts’ reviewer for Drug Safety, an official journal of the ISoP.
-American Society of Clinical Pharmacology and Therapeutics (ASCPT)
Chair, Global Health Community (GHC), 04/2024-04/26;
The Low-to-Middle-Income Country (LMIC) Accelerator Program Selection Committee member for 2025-26
Chaired and developed 5 proposals selected by the Scientific Committee for the ASCPT Annual Meetings
ASCPT Scientific Award Selection Task force member.; Reviewer for Clinical Pharmacology and Therapeutics, an
official ASCPT journal.; Symposium proposals and abstracts reviewer.

Your vision for pharmacovigilance:
Pharmacovigilance is vital to ensuring patient safety across an evolving landscape of therapies and
devices. As innovation accelerates, the field must embrace continuous learning and cross-disciplinary
collaboration. My vision is to foster global harmonization, reduce disparities, and promote proactive
safety strategies. ISoP should lead by integrating diverse expertise to advance science, education, and
policy. Together, we can strengthen pharmacovigilance as a dynamic, patient-centered discipline.

Reasons for standing for election and what you can you do for ISoP:
With a diverse background in academia, regulatory affairs, and the pharmaceutical industry, I offer a
unique blend of expertise to contribute to the ISoP Advisory Board. I have served as a professor, mentor,
regulatory expert, consultant, board member, and pharmaceutical executive specializing in
Pharmacovigilance and Drug Safety, playing a key role in drug and biologics approvals. As an active
subject matter expert, author, and speaker, I am passionate about advancing education and professional
development in pharmacovigilance. As a member of ASCPT, I aim to foster collaboration between ASCPT
and ISoP to enhance education, research, and global practices. I am committed to supporting ISoP’s
training, meetings, publications, special interest groups, and efforts to engage the next generation.
Pharmacovigilance is rapidly evolving with new therapies and devices, requiring adaptability and
collaboration. ISoP needs leaders who understand regional differences and are dedicated to reducing
disparities. My international experience positions me to strengthen partnerships and guide ISoP’s future
mission.

Nationality: Armenian

Qualifications:
MD, MPH

Professional experience:
– Founder/CEO at ETL Healthcare LLC
– Technical Advisory Board Member at ancillarie

Professional experience in committee posts:
– Member of the WHO Global Patient Safety Network (GPSN)
– Member of the International Society of Pharmacovigilance (ISoP)
– Global Pharmacovigilance Society Ambassador for Armenia
– International Editorial Board Member for the Journal of Pharmacovigilance and Drug Research (JPADR)
– Board Member of the Armenian Association of Specialists in Evidence-Based Medicine (AASEBM)
– Co-founder of “Do not Harm’’ Health NGO

Your vision for pharmacovigilance:
– To ensure the highest standards of patient safety through proactive, science-driven safety surveillance.
– To harness innovation, technology, and real-world evidence for rapid detection and prevention of adverse events.
– To build global trust by maintaining transparency, compliance, and ethical vigilance.
– To foster cross-sector collaboration in advancing pharmacovigilance science and practice.
– To contribute to the lifecycle safety of medical products, protecting public health worldwide.

Reasons for standing for election and what you can you do for ISoP:
– I am deeply committed to ISoP’s mission of promoting global patient safety through scientific excellence and collaboration.
– My professional background spans regulatory, industry, and academic sectors, enabling me to bring a well-rounded perspective.
– I aim to represent and strengthen the voice of the Eurasian region within the global pharmacovigilance community.
– I propose launching a dedicated Eurasian ISoP Chapter to foster regional collaboration, education, and capacity building.
– I will actively support the development of ISoP-led training programs, workshops, and research projects.
– I bring experience in organizing international conferences and building strategic partnerships across continents.
– I am committed to promoting digital innovation and real-world data integration in pharmacovigilance practices.
– I will advocate for equitable representation and engagement of emerging countries in ISoP’s initiatives.
– I am ready to contribute to ISoP’s scientific publications, working groups, and outreach strategies.
– With dedication and integrity, I will serve to expand ISoP’s global influence and impact in the evolving safety landscape.

Nationality: Kenyan

Qualifications:
• Doctor of Philosophy (PhD), Medical Science
• Master of Pharmacy in Pharmacoepidemiology and Pharmacovigilance
• Bachelor of Pharmacy

Professional experience:
Pharmacoepidemiologist and Pharmacovigilance Specialist with over 19 years of progressive experience overseeing and strengthening pharmacovigilance systems and post-marketing surveillance in Kenya and across East Africa, developing and influencing regional and national policies on Pharmacovigilance and Postmarketing surveillance, enhancing drug and patient safety through research, and advancing regulatory innovation.
Currently serving as Deputy Director of Product Safety at Kenya’s Pharmacy and Poisons Board, I oversee national efforts in pharmacovigilance, clinical trials, medicines information, and post-marketing surveillance, while managing cross-functional teams and multimillion-dollar global health programs. I have successfully mobilized donor grants to strengthen regional drug safety frameworks, scale digital surveillance systems, and build institutional capacity for pharmacovigilance and post marketing surveillance.

Professional experience in committee posts:
Technical committees: Served as Vice-President of the International Society of Pharmacovigilance-Africa Chapter (ISoP-AFRICA) 2009-2024, Member of the East African Community (EAC) Technical Working Group on Pharmacovigilance and Post-Marketing Surveillance, Member of the African Medicines Regulatory Harmonization (AMRH) Technical Committee on Regulatory Capacity Development in Africa (ToR RCD). Organizing committees: Local Committee member in 3rd ASoP Conference 2016, Part of coordinating Team Mid-Year ISoP training 2019, and Kenya Pharmaceutical Society Symposium committee member 2018-2023.

Your vision for pharmacovigilance:
I envision a patient-centred pharmacovigilance system that safeguards public health through innovation, equity, and evidence. Integrating safety monitoring into public health programs and empowering frontline professionals will be pivotal to advancing patient safety. Harmonizing Africa’s regulatory frameworks is essential to strengthening regional pharmacovigilance and elevating its global status. My vision is that medicines used in Africa will be not only effective, but safe, trusted, and shaped by local realities.

Reasons for standing for election and what you can you do for ISoP:
As a passionate advocate for pharmacovigilance in Africa, I bring over a decade of regulatory experience from Kenya’s Pharmacy and Poisons Board and within Africa’s Harmonisation programs. My leadership has allowed me to collaborate with regulatory authorities, healthcare professionals, and policymakers, refining pharmacovigilance frameworks, risk mitigation approaches, and patient-centred safety strategies. With my deep experience in navigating resource-constrained regulatory environments, fostering multi-stakeholder collaboration, and driving grassroots pharmacovigilance adoption, I believe I will offer the ISoP Advisory Board a wealth of region-specific insights, strategies, and practical solutions. I believe in contextualizing global strategies to fit local healthcare realities. Joining the ISoP Advisory Board would help amplify Africa’s voice in global drug safety.

Nationality: Australian

Qualifications:
Medicines Code of Conduct ed 19.
Certificate of competency in Therapeutic Goods Advertising Code
Certificate of achievement in PV and Pharmacoepidemiology – Role of the QPPV
Bachelor of Science with Honours and PhD in Pharmacology

Professional experience:
Director of Membership and Engagement/ Associate Director of Education (ARCS Australia)
Senior Manager, PV and Med Info, including QPPV (CSL Seqirus, Vifor Pharma, Specialised Therapeutics)
Senior PV associate (BMS), PV Quality Management Specialist and PV Agreements Specialist (CSL)

Professional experience in committee posts:
Conference committee board member for both 2023 ARCS (Sydney) and ISoP (Bali) conferences
ISoP, Western Pacific Chapter President and host of the World Patient Safety Day Event since 2023
ISoP Scientific Board member, co-author of WHO PV Curriculum, Implentation of GPPC
Member of the ARCS Workforce and Capacity summit advisory board and facilitator of the PV stream
Chair of the QPPVA Competency Framework Committee (QACFC) leading the development of a competency framework in Australia for Medicine Sponsors

Your vision for pharmacovigilance:
My vision for PV is to embed a culture of patient safety from the very beginning -starting with university education and continuing throughout professional practice. I aim to ensure all HCP’s recognise PV not as a regulatory burden, but as a powerful tool for improving clinical decision-making. Adverse event reporting should be seen as an opportunity to enhance knowledge, refine benefit-risk understanding, and ultimately deliver better patient outcomes. My goal is to normalise, simplify, and elevate PV across all sectors and career stages.

Reasons for standing for election and what you can you do for ISoP:
With over 20 years of experience spanning academia, industry, and the not-for-profit sector, I bring a well-rounded and strategic perspective to the ISoP Advisory Board. I have worked across PV system design, regulatory compliance in multiple jurisdictions, and global PV education delivery. In my current role at ARCS, I lead national conferences, summits and education programs for professionals in the pharmaceutical sector. I chair the QPPVA Competency Framework Committee and have played a key role in advancing PV competency standards in Australia. I am passionate about building clear pathways for emerging professionals and elevating the role of PV across disciplines. I aim to support ISoP in the global rollout of the GPPC and contribute to its recognition as a professional qualification. I will continue to advocate for stronger regional engagement and ensure all voices are represented. As an Advisory Board member, I will champion ISoP’s scientific and educational agenda, foster partnerships, and promote the professionalisation of pharmacovigilance worldwide.

Nationality: United States

Qualifications:
With over ten years of progressive responsibility at the FDA leading policy development and regulation in drug product safety, alongside more than fifteen years of expertise in pharmacovigilance, medication errors, and risk management, I am a global and U.S. expert in medication error prevention, risk management, and pharmacovigilance. I have led initiatives on global harmonization of container labelling and packaging standards to reduce overall harm associated with medication errors as part of the International Medication Safety Network (IMSN).
I graduated from Massachusetts College of Pharmacy and Health Sciences with Masters of Science in Industrial Pharmacy and Doctorate of Pharmacy and completed a PGY1 Pharmacy Practice Residency.

Professional experience:
Current Position: Senior Director, Head of Risk Management Strategy, AbbVie
I provide global leadership in delivering innovative and strategic risk management excellence, regulatory compliance, risk minimization effectiveness evaluation, and operational excellence for drug products with risk management programs. I provide strategic support for risk assessment and risk management approaches, including additional pharmacovigilance activities and additional risk minimization activities.
Previous positions:
Senior Director, Risk Management Center of Excellence, Pfizer (2021-2024)
Provided strategic risk management support for drug products with risk management programs.
Deputy Director, Office of Medication Error Prevention and Risk Management, CDER, FDA (2010-2021)
Oversaw the post-market safety program, responsible for guiding a wide range of activities related to risk assessment and mitigation, medication errors, research, training, and policy. Served as FDA liaison to international regulators and standard-setting organizations for drug nomenclature and medication errors.

Professional experience in committee posts:
Active member of ISOP since 2021. Participated as FDA representative prior to 2021. Active member of NASoP since 2021. Led the creation of the content for the medication error module for AM2P, an education and accredited, online training program designed for Industry. Active member and contributor to Medication Error SIG since 2018. Presented on various topics including falsified medication in SIG meetings. Active member and contributor to Pharmacovigilance in the community SIG since 2023. Active member and contributor to RMM SIG digital working group since 2024.

Your vision for pharmacovigilance:
The future of pharmacovigilance should be aimed towards creating a proactive, global system that leverages AI, real-world data, and digital health tools for enhanced drug safety monitoring. Integration of diverse data sources and exploring opportunities for international collaboration, standardization, and best practices will promote global harmonization. Exploring the feasibility for patient engagement and education, thus empowering individuals to play an active role in medication safety.

Reasons for standing for election and what you can you do for ISoP:
As an Advisory Board member at ISoP, I aim to leverage my experience and expertise to advance the ISOP’s mission of global medication safety. I am committed to expanding ISoP’s global reach, focusing on opportunities to engage underrepresented regions. By fostering collaboration and building partnerships with regulatory agencies, academic institutions, pharmacovigilance centers, patient safety organizations, and industry stakeholders, we can strengthen and enhance patient safety. I will also promote the development of advanced training programs for the next generation of pharmacovigilance professionals to equip them with the necessary skills and knowledge. I am committed to creating and supporting mentorship and fellowship opportunities for students, fostering growth, and inspiring future leaders in the field. As a representative of ISoP in international forums, I seek to influence policy and collaborative research on emerging issues such as digital health and AI in PV as well as innovative risk management approaches.

Nationality: German, Romanian

Qualifications:
Medical Doctor, Specialty: Clinical Genetics
Master of Science: Pharmaceutical Medicine

Professional experience:
Physician, Clinical Geneticist, Genetic Counseling – Prenatal Diagnostic lab
Global Clinical Operations – responsible for safety reporting to investigators and Ethics Committees for clinical trials
Country Head Pharmacovigilance
Head of Medical Information
EU QPPV Deputy
Stufenplanbeauftragte (Graduated Plan Officer)

Professional experience in committee posts:
Member of ISoP risk communication SIG digital working group
Co-chair of the German trade association vfa’s PV group
Member of Germa trade association Pharma Deutschland´s PV group, working e.g. in the EU QPPV/Stufenplanbeauftragte FAQ committee
Member of MSc Pharmaceutical Medicine student selection and student examination committee, PV Lecturer

Your vision for pharmacovigilance:
Pharmacovigilance is at a pivotal moment. As we navigate an increasingly complex therapeutic landscape, marked by accelerated drug development, real-world data integration, and evolving patient expectations, our discipline must evolve from a regulatory necessity into a proactive, patient-centered science. My vision is to help shape a future where PV is not only reactive but predictive, not only compliant but empathetic, caring, and people choose PV out of passion.

Reasons for standing for election and what you can you do for ISoP:
Reasons for standing for election:
I believe in ISoP´s mission to advance the science and practice of PV worldwide. With over 18 years of experience in PV, I bring a deep understanding of both operational realities and strategic foresight. I have led cross-industry initiatives such as Patient Safety Day campaigns and advocacy for AE reporting, and I regularly speak at international conferences on topics ranging from patient-centricity and digital transformation to inspection readiness and risk minimization. These experiences have equipped me to contribute meaningfully to ISoP’s strategic direction and outreach.
What can I do for ISoP:
Champion innovation: support ISoP’s efforts to integrate digital tools and methodologies into PV practice; Strengthen connectivity and education: contribute to ISoP’s training programs and mentor emerging professionals, strengthen collaboration within and between chapters; Enhance visibility and collaboration: advocate for pharmacovigilance as a key pillar of public health and patient trust; Promote inclusivity: amplify voices from underrepresented regions and foster multicultural dialogue.

Nationality: Ugandan

Qualifications:
1. Fellow International Society of Pharmacovigilance
2. Doctor of Philosophy (PhD) in Public Health-Université catholique de Louvain, Belgium
2. Master of Business Administration degree- Herriot-Watt University, UK
3. Master of Science in Epidemiology and Biostatistics degree- Makerere University
4. Bachelor of Pharmacy (Honors) degree-Makerere University

Professional experience:
1. Director Product Safety, National Drug Authority Uganda- 2016 to Present
2. Head of the Drug Information Department, National Drug Authority Uganda – 2006-2016
3. Trial Manager, Medical Research Council / Uganda Virus Research Institute (MRC / UVRI) Research Unit on AIDS in Uganda, Uganda 2005-2007
4. Clinical Trial Coordinator, (MRC / UVRI) Research Unit on AIDS in Uganda, Uganda 2003-2005

Professional experience in committee posts:
1. President, African Chapter of the International Society of Pharmacovigilance, 2019-2022
2. Member, ISoP patient safety engagement SIG and Risk communication SIG
3. National Taskforce on Anti-Microbial Resistance, 2015 to date
4. Advisory Committee of the Pan African Clinical Trials’ Registry Advisory Group
5. Vice Chair of the African Vaccine Regulator’s Forum, September 2011-Nov 2014
6. Medicines’ Transparency Alliance Council, Uganda 2012 to date
7. Head, National Pharmacovigilance Centre-Uganda
8. HIV Drug Resistance Network, Uganda
9. East African Community Pharmacovigilance and Post Market Surveillance expert working Group

Your vision for pharmacovigilance:
I envision a world where every medicine and health product is used safely, with patient well-being at the center of every decision. My goal is to foster strong, inclusive, and harmonized global pharmacovigilance systems. I believe in empowering communities and professionals alike to report, learn, and act on safety data. Through collaboration, innovation, and transparency, we can build trust in medicines and health systems. As a board member, I will champion equity, scientific excellence, and meaningful impact in patient safety.

Reasons for standing for election and what you can you do for ISoP:
I bring over 20 years of experience in pharmacovigilance practice and research at national, regional, and global levels. Africa, with 20% of the world’s population and disease burden, yet contributing only 2% of clinical trial safety data, underscores the urgent need for robust pharmacovigilance systems. I intend to advocate for impactful strategies I have implemented, such as integrating pharmacovigilance into pre-service health professional training, promoting patient-led reporting, and leveraging digital health technologies. I am eager to share innovative approaches that have successfully driven engagement across Africa, promoting evidence-based decision making to the global level. Beyond my deep expertise in pharmacovigilance, I also bring two decades of regulatory leadership experience, offering a valuable perspective to strengthen global pharmacovigilance practices. I am fully committed to contributing at least 5 hours a week and supporting any specific roles of the Advisory Board with my skills and dedication.

Nationality: Nigeria

Qualifications:
Bachelor’s degree in pharmacy (B.Pharm), Master’s degree in International Public Health (IMPH), Master of Medical Sciences in Global Health Delivery (MMSc.-GHD), currently a PhD candidate (2026) and ISoP Fellow.

Professional experience:
I have over 20 years of experience in pharmacovigilance and patient safety. I am a Senior Manager on pharmacovigilance at the United States Pharmacopeia (USP) where I lead USP’s global work on pharmacovigilance and regulatory system strengthening activities. I worked as a regulator for over 16 years at the National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria where I was instrumental to establishing the national pharmacovigilance system. I have supported the WHO and other organizations as a subject matter expert in various pharmacovigilance areas including support to strengthen pharmacovigilance systems in different low- and middle-income settings and to establish systems to introduce new drugs and vaccines in public health programs.
I currently serve on the WHO’s Global Advisory Committee on Vaccine Safety (GACVS).

Professional experience in committee posts:
I am currently the President of the Africa chapter of ISoP where I provide strategic leadership in shaping the program and activities of the chapter. I previously served as the Secretary of the chapter from December 2019 to July 2024. I have served on several committees of ISoP including the Scientific Committees for the annual meeting in Oman in November 2021 and the 2nd African Society of Pharmacovigilance Conference in Accra, Ghana in December 2015. I am a member of several ISoP SiGs.

Your vision for pharmacovigilance:
Pharmacovigilance as profession has grown tremendously over the years in terms of its scope and the people who embrace it as a career path. Furthermore, the changing practice environment provides a lot of opportunities to shape the future direction of the profession and the practitioners. My vision is to ensure that the strategic direction of the profession is aligned with the current needs of the environment and the people.

Reasons for standing for election and what you can you do for ISoP:
In my former role as the secretary of the Africa chapter of ISoP, I coordinated activities involving several pharmacovigilance experts and practitioners in the continent. I saw the passion people brought to the topic of patient safety and the gaps in knowledge, experience, networks and a supportive environment to perform. In my current role as the President of the chapter, I work with my team to provide the vision, strategies and policies to advance pharmacovigilance practice in Africa. With its large pool of young, dynamic and talented professionals as well as a good number of very experienced PV experts and professionals, Africa has the potential to contribute meaningfully to efforts to enhance the science and practice pharmacovigilance. I plan to utilize my role as the President of the chapter and my work at the global level to harness the resources within and outside Africa to further contribute in advancing the practice of PV and draw more professionals to the fold.

Nationality: Nigerian

Qualifications:
B.Pharm, 1989. M.Sc, 1992; Ph.D, 2007; Pharm D, 2018; PG Certificate in PV & PEpi LSHTM UK,

Professional experience:
2010 – Date: Core Technical Member, National Drug Safety Advisory Committee for NAFDAC, Nigeria.
2021- 2025: Secretary General, West African Postgraduate College of Pharmacists (WAPCP)
2019 – Date: Research Team lead for Pharmacovigilance (PV) at the African Centre of Excellence for Drug Research, Herbal Medicine Development and Regulatory Science (ACEDHARS) University of Lagos Nigeria.
2017- 2023: Prof & Head, Department of Pharmacology, Therapeutics and Toxicology, College of Medicine University of Lagos, Nigeria.
2012 – Date: Coordinator, Southwest PV Zone for NAFDAC, Nigeria
2021-2023: Site Investigator/Coordinator, Training and Implementation Grant: Cohort Event Monitoring (CEM): Safety Signal Detection Post Vaccination With COVID-19 Vaccines in Nigeria; National Agency for Food and Drug Administration and Control (NAFDAC) in collaboration with the United States Centre for Disease Control and Prevention (US CDC) through the University of Maryland Baltimore.

Professional experience in committee posts:
Active member in the African Society of Pharmacovigilance
Third Prize Poster Award at International Society of Pharmacovigilance (ISoP) Conference Ghana 2010
Editor-in-Chief, West African Journal of Pharmacy

Your vision for pharmacovigilance:
My vision is to advance global pharmacovigilance through collaboration, innovation, and patient-centered
approaches. I will promote mentorship, capacity building and evidence-based decision-making. I will leverage technology to enhance our PV activities. I will also prioritize diversity, equity, and inclusion, ensuring all voices are heard. Together, we will improve patient safety and public health outcomes.”

Reasons for standing for election and what you can you do for ISoP:
As a pharmacovigilance expert, I am excited to stand for election as an advisory board member of the International Society of pharmacovigilance. With experience working in resource-limited settings, I have developed a deep understanding of the challenges and opportunities in African pharmacovigilance.
I successfully co-founded and served as Pharmacovigilance Research Team Lead for ACEDHARS, a World Bank implementation project worth six million US dollars from 2019 to date.
I am committed to promoting global collaboration, capacity building, and knowledge-sharing to enhance patient safety and public health in Africa and beyond. I passionately desire fostering partnerships and advancing pharmacovigilance in Africa, while contributing to the society’s global mission.”
I have co-authored two books on PV and published over 50 original scientific papers in the field of PV and Pepi including our latest publication on the medsafety app in April 2024. I will use these experiences to support the board towards implementing ISoP overall strategic objectives.

Nationality: British

Qualifications:
MSc Pharmacology (Kings College London)
BSc (Hons) Biomedical Chemistry (Sheffield)

Professional experience:
As a dynamic, visionary, and credible senior leader, I bring a wealth of Pharmacovigilance expertise and technical depth gained across various Pharmaceutical organisations. In my current role as Director of PV (Ipsen) & Chair of the UK ABPI (Association of the British Pharmaceutical Industry) PV Expert Group, I operate at the forefront of the PV landscape—collaborating across regulatory, scientific, and policy domains. My experience includes key leadership roles such as the Qualified Person for Pharmacovigilance (QPPV), where I have worked closely with senior executives to ensure compliance with global regulatory frameworks including the European Union (EU) Directive 2010/84/EU & Clinical Trials Directive (CTD), UK Human Medicines Regulation (HMR) Part 11, United States (US) CFR 314, and the International Conference on Harmonisation (ICH) guidelines. Through these positions, I have led the successful implementation and oversight of comprehensive PV systems aligned with both corporate governance and local regulatory expectations through strong leadership.

Professional experience in committee posts:
Strong experience in committee posts spanning over seven (7) years as chair of the ABPI PV expert group and the ABPI board steering group (BSG) to represent the UK industry voice and drive forward agreed objectives with the UK government, MHRA, NICE and NHS England. As a result of serving as chair, strong relationships have been formed and remain fruitful which has enabled the shaping, lobbying and advocacy of the external landscape. Internally, or within organisational posts, I have served on multiple steering committees, GxP leadership teams and decision boards, respectively.

Your vision for pharmacovigilance:
My vision is to first connect our community with our purpose by championing global leadership in PV and upholding the highest standards of scientific integrity, transparency, and patient-centric responsibility. I believe that building strong, collaborative relationships with regulators, healthcare professionals, and global partners is key to ensuring robust benefit-risk and the safe and effective use of medicines. Through proactive risk management, open dialogue, and a commitment to continuous learning and innovation, I strive to advance the field and make a meaningful impact on public health.

Reasons for standing for election and what you can you do for ISoP:
With my strong leadership skills and PV acumen, I am excited to fostering a stronger, strategic, and more purposeful ISoP community of the future. As an active ISoP chapter member (UK-IRL) and SIG member (Pharmacogenomics & PV in the community) through my lens, I view my candidacy as a pivotal enabler to influence global policy, enhance post-marketing surveillance, and foster scientific collaboration across jurisdictions. If selected, my goal is to support the ISoP in driving meaningful yet impactful change, promoting regulatory harmonisation, and upholding the highest standards of ethical vigilance and patient safety through inclusive, empowering leadership. I am especially eager to contribute to strategic discussions that shape the global PV landscape, drawing on my collaborative approach, scientific acumen, and regulatory insight to offer meaningful perspectives and help guide the board’s long-term direction of travel. It is time for an ISoP refresh, and this alone remains my primary reason for standing for election.

Nationality: Egyptian

Qualifications:
Hadir hold a degree in clinical pharmacy from Ain Shams University, Egypt, and executive management in healthcare certificate from Harvard School of Public Health.

Professional experience:
Hadir has 24 years experience in the Pharmaceutical sector, including 14 years extensively in pharmacovigilance domain. Currently, she is a lecturer at MSA University, Egypt. Her most notable contributions to pharmacovigilance on the international level include serving as a WHO consultant in Regulatory System Strengthening. In this role, she has supported regulatory authorities in various countries to establish and enhance their pharmacovigilance systems in alignment with the WHO Global Benchmarking Tool. Additionally, as an independent pharmacovigilance consultant and lead auditor, she evaluates the compliance of pharmacovigilance systems within the pharmaceutical industry to ensure adherence to applicable regulations across different countries.

While serving at the regulatory authority, she co-founded and led of the Egyptian Pharmacovigilance Center. Hadir has also contributed significantly to the development of Good Pharmacovigilance Practice guidelines in Arab countries. She acted for integrating PV teaching in Academia in Egypt.

Professional experience in committee posts:
Hadir is member of the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP) and ISoP Scientific Board. Additionally, she is the chair of the local organizing committee and co-chair of the scientific committee of ISoP 2025 Cairo annual meeting. Chair of ISoP Egypt Chapter.

Your vision for pharmacovigilance:
Hadir envisions pharmacovigilance as a global safeguard for medicine safety and effectiveness, driven by proactive, data-informed monitoring. Empowered stakeholders, through education and collaboration, are key to its success.
Integrating AI and real-world evidence ensures PV evolves with medical innovation.
Harmonized global regulations must underpin robust safety systems, especially in underserved regions.

Reasons for standing for election and what you can you do for ISoP:
1. Enhancing Membership Value through tailored packages that meet the interest of professionals in different sectors to ensure long-term engagement across diverse career stages and regions.
2. Diversifying Revenue Streams and Financial Sustainability; develop diversified funding strategies, and value-added services in a sustainable financial model which will empower ISoP to invest in critical initiatives while maintaining independence, integrity and expand its impact.
3. Strengthening Global Collaborations and Strategic Partnerships with key stakeholders including international scientific societies, regulators, academia, industry, and patient organizations to amplify our collective action on global pharmacovigilance priorities.
4. Strengthening PV Education, qualification programs and researches that address emerging challenges and opportunities in drug safety.

Nationality: Mexican-American

Qualifications:
• Medical Doctor with Specialty in Internal Medicine, Board Certified
• Doctoral Degree: Sciences in Clinical Epidemiology (Pharmacoepidemiology & Pharmacovigilance), Erasmus University, Netherlands.
• Master’s Degree: Outcomes and Effectiveness Research, Darthmouth Medical University.
• Master’s Degree: Sciences: Epidemiology and Biostatistics, Major: Pharmacoepidemiology and Pharmacovigilance, McGill University.

Professional experience:
Management: Dr. Salas has over 20 years of experience in PE/PV across various therapeutic areas. Currently, Dr. Salas is the Global Safety Therapeutic Area Head in Oncology at Bayer Pharmaceuticals Inc. In the past, Dr. Salas was the Head of the Global Epidemiology Department at Daiichi Sankyo, and AstraZeneca Regional Medical Director.
Patient Care and Clinical Research: Dr. Salas has worked as attending physician at the Emergency Department and Internal Medicine Department, and clinical researcher in various hospitals including CMN “Siglo XXI and Raza”, Mexico; University of Birmingham in Alabama, USA; and Royal Victoria Hospital, Canada.
Research and Teaching: Currently, Dr. Salas holds the positions as Adjunct Scholar with UPenn and Rutgers U. She was Tenure Track Full Professor of Pharmacoepidemiology and Pharmacovigilance at the School of Public Health and Preventive Medicine, UAB and Veterans Administration Hospital, USA; Professor of Pharmacology, UNAM, Mexico. Mentorship pre-graduate and postgraduate students in different parts of the world. Associated Editor of the Pharmacoepidemiology and Drug Safety Journal.

Professional experience in committee posts:
• ISoP: ISoP Advisory Board Member and Special Interest Group Coordinator. Scientific Committee Chair of the Annual ISoP Meeting in Montreal, Canada, and Scientific Committee Chair of ISoP-LatAm. In the past, Chair of North America Society of Pharmacovigilance (NASoP).
• ISPE: Global Development Committee Chair at ISPE. Scientific Planning Committee Chair, 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Co-Chair of the 2012-Annual Mid-Year Meeting of ISPE held in Miami, Florida.
• ISPOR Chair of the Medication Adherence Special Interest Group (SIG) at the International Society of Pharmacoeconomics and Outcomes Research (ISPOR).
• US Government: Representative of the UAB Center for Education and Research on Therapeutics (CERTs) in Musculoskeletal disorders at the National CERTs, Agency for Healthcare Research and Quality (AHRQ), US Human and Health Services Department. Chair of the Grant Reviewer Committee. US Human and Health Services Department, Division of Medicine and Dentistry (DMD), Chiropractic Demonstration Projects Grant Program. DSI Representative in the FDA Initiative: Shared REMS, USA.

Your vision for pharmacovigilance:
For me, ISoP should serve as the global leader in providing an unbiased scientific forum for education and research in pharmacovigilance (PV), facilitating the exchange of ideas and promoting the safe and rational use of medicinal products worldwide. Furthermore, ISoP should be a cornerstone in advocating patient safety through the development of guidelines and the creation of innovative methods for early detection, assessment, interpretation, prevention, and management of adverse effects related to medicinal products.

Reasons for standing for election and what you can you do for ISoP:
I am eager to lead the ISoP organization to further advance the development of pharmacovigilance worldwide. My extensive experience in leadership roles across academia, government, and industry, positions me as a strong candidate to direct ISoP. I have a proven track record of consolidating groups, fostering the exchange of ideas, and implementing innovative methods to attract more members to ISoP. During my tenure as the leader of the NASoP Chapter, we achieved a significant increase in membership, including many experts in pharmacovigilance. I introduced webinars into our routine monthly meetings, offering fresh insights from representatives across all sectors. Additionally, I encouraged members to engage in key topics of interest, which led to several scientific publications. ISoP should maintain a presence in major international forums on pharmacovigilance to discuss safety-related topics, ensuring that its members take pride in belonging to this esteemed organization.

Nationality: Egyptian

Qualifications:
Harvard Medical School, USA. Global Clinical Scholars Research Training (GCSRT), 1-year program.
Karolinska Institute, Sweden. Master of Medical Sciences in Health Informatics.
Université de Bordeaux- Eu2P Programme, France. Master of Science in Pharmacovigilance and Pharmacoepidemiology.
Alexandria University, Egypt. Master of Sciences in Hospitals Administration.
Faculty of Pharmacy, Alexandria University, Egypt. B.Sc. in Pharmaceutical Sciences.
Certifications: Certified Professional in Healthcare Quality (CPHQ, USA); ISQua Fellowship; Clinical Drug Development (Uppsala University); EIT Health “Co-Up Lab” (Karolinska Institutet).

Professional experience:
I am currently a PhD candidate in Public Health Sciences (Epidemiology) at Karolinska Institutet and work as a Pharmacovigilance Specialist at a CRO in Stockholm. I also serve as Assistant Deputy Editor for the International Journal for Quality in Health Care (IJQHC). Previously, I worked as a tutor in the Master’s Programme in Health Informatics at Karolinska Institutet, as an External Regulatory Consultant with the Institute of Pharmacovigilance in Prague, and as a Lecturer in Health Services Management at Umm Al-Qura University in Saudi Arabia. I began my career as a hospital pharmacist with the Ministry of Health in Egypt. I am a licensed pharmacist in Egypt (with no expiry) and was also licensed in Saudi Arabia from 2019 to 2021. I previously served as Chair of the Swedish Network for International Health (SNIH) and currently sit on the board of the Doctoral Students’ Association at Karolinska Institutet.

Professional experience in committee posts:
Co-founder and Lead of the ISoP AMR Subgroup (within the Medication Errors SIG); organizer and moderator of the ISoP AMR Webinar Series; author of the AMR Subgroup abstract published in Drug Safety. Member, ISoP Students Group Coordinating Committee. Contributor to the PV Qualification SIG (PV certification exam item writing and review).

Your vision for pharmacovigilance:
Pharmacovigilance should be a proactive, globally engaged, and digitally driven field that safeguards patient safety and optimizes medicine use. It must evolve beyond passive reporting to actively inform policy, guide antimicrobial resistance (AMR) surveillance, and support health system performance. By advancing patient-centred pharmaceutical innovation, strengthening capacity by focusing on technology, and promoting global collaboration to enhance human performance, pharmacovigilance will be strengthened.

Reasons for standing for election and what you can you do for ISoP:
As co-founder and lead of ISoP’s AMR Subgroup and a member of the ISoP Students Group Coordinating Committee, I bring coordination experience, leadership, and a collaborative mindset. I am particularly interested in contributing to the coordination of ISoP Education and Training or supporting ISoP Chapters and SIGs, building on my background in teaching, healthcare quality, and public health. I have organized successful ISoP AMR webinars, supported SIG activities, and contributed to peer-reviewed publications. I aim to strengthen collaboration between ISoP SIGs and Chapters, encourage participation from diverse regions, and support access to high-quality training opportunities. I am fully committed to ISoP’s mission and prepared to dedicate the required time to help advance the Society’s global reach and impact. I will also bring a strategic, action-oriented perspective to support innovation, education, and long-term sustainability across ISoP’s initiatives.

Nationality: Italian

Qualifications:
MD, PhD, Full Professor of Pharmacology, School Of Medicine, University of Bordeaux

Professional experience:
2002, Medical student (Messina, Italy): development of an Italian network of GPs interested in pharmacovigilance activities.
2003, Sicilian Pharmacovigilance Regional Centre, 2003, disproportionality analyses and automated signal detection (Verona, Italy; Pr Gianpaolo Velo).
2005-08, signal detection group of the Italian Medicine Agency (AIFA).
2007, PhD Student, strengths and limits of assessing drug risks in real life (Messina, Italy; Bordeaux, France).
2008-11, Post-Doc student participation to research projects funded by FP7, as EU-ADR, SOS, and ARITMO (Bordeaux, Pr Moore and Pr Bégaud).
2011-14, Researcher, INSERM U1219, Bordeaux Population Health, Pharmacoepidemiology Team
2014-2017
– Hospital Practitioner; management of adverse events during in clinical trials settings (Clinical research unit of Bordeaux University hospital),
– Researcher; real-life safety studies conducted by the French program “Drugs-Safe”, funded by the French Medicine Agency (ANSM).
2017-, Associate Professor of Pharmacology in Bordeaux
2017-, Coordinator of the European Programme of Pharmacovigilance and Pharmacoepidemiology (Eu2P).
2021-, Director of Bordeaux PV Center
2021-22, Coordination of the French survey of the safety of Comirnaty anti COVID-19 vaccine
2022 -, Full Professor of Pharmacology in Bordeaux

Professional experience in committee posts:
2017-2022, Council Member of EACPT, on behalf of French Society of Pharmacology and Therapeutics
2020-2023, Steering Group of the ENCePP, Elected member
2020-, Medical Commission of the University Hospital of Bordeaux, elected member
2022-2025, ISoP Advisory Board Member

Your vision for pharmacovigilance:
Pharmacovigilance is evolving very fast, and we have to imagine new solutions for helping drug safety experts in drug safety assessment. Use system interoperability to facilitate the spontaneous reporting, and foster their quality, test and implement artificial intelligence for day by day activities, and move forward for knowledge integration to make all the process of drug safety assessment more standardized and efficient.

Reasons for standing for election and what you can you do for ISoP:
Over the past three years, I’ve had the privilege of serving on the Advisory Board during a period of remarkable growth for ISoP. Special Interest Groups, Regional Chapters, and all the ISoP communities are the lifeblood of ISoP’s growth—driving engagement and innovation across pharmacovigilance worldwide. ISoP is now poised to lead a dynamic new era in pharmacovigilance by deepening global partnerships, advocating interdisciplinary collaboration and amplifying mentorship. I am committed to fostering rigorous research, engaging new professionals, and embracing innovation—including the responsible integration of Artificial Intelligence into pharmacovigilance practices. ISoP plays a crucial role in shaping a global vision for drug safety. I’m proud of what we’ve achieved so far, and I would be honored to continue this work. With humility and determination, I ask for your support in being re-elected to the next AB.

Nationality: US Citizen/UK Permanent Resident

Qualifications:
MSc, Industrial Engineering (Health Systems Design), Iowa State University
BSc, Industrial Engineering, Iowa State University
Executive Certificate in Drug Discovery and Development, Temple University School of Pharmacy

Professional experience:
Principal, The Pareto Group (2024–present): Strategic counsel on PV infrastructure, biobank governance, precision medicine, and regulatory frameworks in Africa, EU, and US.
Associate Partner, Red Nucleus (2021–2024): PV, regulatory, clinical ops, and records management services for top-30 pharma sponsors.
Head, Pharmacovigilance Solutions, Bioclinica (2019–2021): Developed PV solutions for EMEA and APAC markets.
Managing Director, Kinapse Ltd / Syneos (2015–2018): Oversight of preclinical and regulatory services for key global pharma accounts.
Senior Director, Pfizer (2001–2014): Led Regulatory & Safety Strategic Management, global PV operations, and post-M&A integration.

Professional experience in committee posts:
Treasurer, ISoP North American Chapter (2023–present): Chapter financial stewardship and governance contributions. Currently leading the development of the Member Mentoring program.
ISoP NASoP Nominating Committee (2020)
ISoP NASoP Working Groups: COVID-19 Response, Patient Centricity, Diversity in Clinical Trials
ISOP SIG: PGx
ISoP Annual Meeting Local Organizing Committee (2024–2025): Lead for sponsor identification and support for Montreal (2024) and Cairo (2025)

Your vision for pharmacovigilance:
Pharmacovigilance must evolve as a globally inclusive discipline that integrates patient-centred approaches, real-world data, and genomics. PV should not only detect risks but also guide safer therapies through better science, policy alignment, and healthcare system integration, particularly in underrepresented regions.

Reasons for standing for election and what you can you do for ISoP:
I seek election to the ISoP Advisory Board to enhance global equity, regional representation, and sustainable growth of ISoP. My financial acumen, combined with experience across regulatory, pre-clinical, and precision medicine, and leadership in both established and emerging markets, uniquely positions me to support ISoP’s strategic goals.

I can help strengthen ISoP’s presence in Africa and low- and middle-income countries, advance PV education, and build cross-sector collaborations.
Additionally, I will prioritize member engagement, fiscal accountability, and the bridge between science, policy, and patient outcomes.

Nationality: Mexican

Qualifications:
I hold a Bachelor’s degree in Pharmaceutical Biological Chemistry from the National Autonomous University of Mexico (UNAM), a Master’s degree in Pharmacology from CINVESTAV-IPN, and a PhD in Medical Sciences from Faculty of Medicine of UNAM. My academic background has been consistently focused on drug safety, with graduate theses addressing intensive pharmacovigilance and pharmacogenomic risk factors for anthracycline-induced cardiotoxicity in pediatric cancer patients. I have complemented my formal education with advanced training in clinical research, bioethics, regulatory science, and international pharmacovigilance methodologies. I have been recognized with academic honors and distinctions, and I am currently a Member of the Mexican National System of Researchers. This solid academic foundation supports my multidisciplinary work at the intersection of pharmacovigilance, pharmacoepidemiology, and pediatric therapeutics.

Professional experience:
I currently serve as Head of the Department of Pharmacoepidemiological Research at the Hospital Infantil de México Federico Gómez, one of the country’s leading pediatric institutions, and as a lecturer in Pharmacovigilance at the Faculty of Chemistry, UNAM. Over the past decade, I have held strategic roles in both clinical and regulatory pharmacovigilance, including coordination of hospital pharmacovigilance units, development of risk minimization strategies, and implementation of antimicrobial stewardship programs. My work has bridged research, education, and health policy, with a strong focus on pediatric drug safety. I have published in peer-reviewed journals, led multidisciplinary research projects, and mentored numerous undergraduate and graduate students. I have also participated as a speaker at numerous national and international conferences, and organized training programs, academic events, and symposia to strengthen pharmacovigilance capacity in Mexico and Latin America. As part of my commitment to knowledge dissemination, I have edited a national textbook on hospital pharmaceutical services and authored a chapter on causality assessment in clinical pharmacy. Furthermore, I have represented academic institutions in regulatory working groups, contributing to the revision of key Mexican pharmacovigilance standards promoting evidence-based regulation and institutional collaboration.

Professional experience in committee posts:
I have held leadership roles in national and international committees dedicated to pharmacovigilance, pharmaceutical sciences, and patient safety. I currently serve as President of the Latin American Chapter of the International Society of Pharmacovigilance. In this capacity, I led the creation of the Latin American Pharmacovigilance Block—an unprecedented collaborative initiative aimed at strengthening regional integration and dialogue among regulatory authorities, academia, and professional associations. I have also successfully organized two Latin American ISoP Symposia, which have become key platforms for sharing scientific advances and building capacity in the region. Since 2017, I have served on the Board of the Mexican Association of Pharmacovigilance in various capacities, and I recently concluded my term as Vice President. Additionally, I have chaired the Committees on Hospital Pharmacy and on Pharmacovigilance and Technovigilance at the National College of Pharmaceutical Chemists of Mexico. At the institutional level, I have actively participated in hospital committees on ethics, pharmacovigilance, and quality, contributing to interdisciplinary strategies for patient safety and clinical governance. I have also represented academic institutions in national regulatory standardization processes, advancing regulatory alignment through evidence-based scientific input.

Your vision for pharmacovigilance:
I envision a scientifically robust pharmacovigilance system that goes beyond compliance to actively generate new knowledge on drug safety. My goal is to strengthen its methodological foundations and integrate it into clinical and public health decision-making. I advocate for a culture of evidence, innovation, and patient-centeredness. Pharmacovigilance should be seen not only as a regulatory tool, but as a dynamic scientific discipline.

Reasons for standing for election and what you can you do for ISoP:
I am standing for election because I believe in the transformative power of pharmacovigilance to protect patients and improve health systems. ISoP has played a crucial role in my professional development, and I am committed to giving back to the Society by strengthening its presence in Latin America, facilitating cross-regional initiatives, and expanding educational opportunities for emerging professionals. I will advocate for equity in participation, support the development of Spanish-language resources, and promote stronger alliances between regulatory authorities, academia, and health institutions. I also aim to contribute to ISoP’s strategic planning by integrating the perspectives of underrepresented regions. Through a collaborative, multilingual, and science-based approach, I am committed to advancing ISoP’s mission and ensuring that pharmacovigilance remains relevant, responsive, and impactful.

Nationality: Mexican/Spanish

Qualifications:
I am a medical doctor and senior researcher with experience in pharmacovigilance, pharmacoepidemiology, and health data science. At IDIAP Jordi Gol, I have coordinated international vaccine safety studies, developed innovative methodologies using real-world data, and led multidisciplinary teams. Coordinator for the flagship Centres de Salut Integral de Referència (CSIR) Project in Catalonia, I drive integrated, high-quality primary care reform through innovative organizational models and rigorous evaluation of clinical and population health outcomes. I am also a lecturer at the Universitat Oberta de Catalunya, committed to capacity building and mentorship. My leadership roles include co-coordinating the ISoP European Chapter, co-chairing the Data Expert and Access Partners (DEAPs) Working Group at VAC4EU, and serving as a member of the European Health Parliament’s Well-being for Health Care Workers Committee. These experiences have strengthened my ability to foster collaboration, promote scientific innovation, and champion diversity and inclusion in pharmacovigilance-pharmacoepidemiology worldwide.

Professional experience:
Senior Researcher and Project Coordinator, IDIAP Jordi Gol (Barcelona): Leading multi-country studies on vaccine safety and effectiveness, managing international research consortia, and developing innovative pharmacovigilance-pharmacoepidemiology methodologies. Coordinator of the Centre de Salut Integral de Referència (CSIR) Project, a flagship health system reform initiative in Catalonia, focused on integrated, high-quality primary care, cross-functional team management, and collaboration with health authorities.

Researcher at Sant Joan de Déu Hospital on mental health and well-being in migrant population.
Lecturer at Universitat Roviri I Virgilli and at the Faculty of Health Sciences, Universitat Oberta de Catalunya: Teaching and mentoring in public health.
Collaborator with regulatory agencies, healthcare providers, and patient organizations on pharmacovigilance-pharmacoepidemiology and real-world evidence projects.

Professional experience in committee posts:
Co-coordinator of the Data Expert and Access Partner Working Group (DEAPs WG) at VAC4EU: In this role, I help coordinate a network of 16 partner organizations across Europe, facilitating access to and standardization of observational healthcare data for real-world evidence generation, and supporting the development of guidelines and best practices for data-driven pharmacoepidemiology studies.
Co-coordinator of the ISoP European Chapter: I contribute to the strategic planning and implementation of ISoP’s scientific research and training activities in Europe, supporting collaboration among member centers, organizing scientific events, and promoting the inclusion of underrepresented regions and perspectives within ISoP.
Member of the European Health Parliament, Well-being for Health Care Workers Committee: I worked alongside European leaders to develop policy recommendations and advocate for the health and well-being of healthcare professionals at the European level.
Additionally, I have served on scientific and organizing committees for international conferences, including chairing the ISoP Mid-Year Symposium 2024 in Barcelona, and have participated in research consortia steering committees, focusing on multi-country pharmacovigilance-pharmacoepidemiology projects and cross-sector collaboration.

Your vision for pharmacovigilance:
I envision a pharmacovigilance community that leads through scientific innovation, harnessing real-world evidence and artificial intelligence to protect patient safety and public health. My goal is to build global capacity through education and mentorship, empower professionals in all regions, and drive strategic, transdisciplinary collaboration. Above all, I believe pharmacovigilance must be inclusive and representative, ensuring every voice shapes our field’s future.

Reasons for standing for election and what you can you do for ISoP:
I am standing for election to the ISoP Advisory Board to serve and empower our global community. My commitment to ISoP and its members is unwavering: I will champion scientific innovation, expand educational and mentorship opportunities – especially in under-resourced settings—and actively promote the participation of underrepresented groups. My leadership in international research, ISoP’s European Chapter, VAC4EU, and the CSIR Project equips me to foster impactful collaborations and drive meaningful patient safety outcomes. I am dedicated to making ISoP a leader in scientific excellence, diversity, and inclusion. Together, we can shape a future where pharmacovigilance is a force for safer medicines and healthier societies everywhere.
I am deeply committed to ISoP’s mission and to working collaboratively with all members to advance our shared goals. I look forward to contributing my experience, passion, and vision to the Advisory Board and to the continued success of ISoP and its global community.

Nationality: British / United Kingdom

Qualifications:
• DPhil (PhD) Clinical Medicine, Wolfson College, University of Oxford, UK
• MPharm, University of Nottingham, UK

Professional experience:
• Assistant Professor in Clinical Pharmacy, University of Birmingham, UK (2024-present)
• Coordinator, Global Pharmacovigilance (2018 –present)
• Project / Research Manager, The Global Health Network, University of Oxford, UK (2022-2024)
• PhD Student (thesis title ‘Can building a community of practice improve pharmacovigilance in
low-resource settings?’), University of Oxford, UK (2018-2022)
• Rotational Pharmacist, University Hospitals of North Midlands NHS Trust, UK (2018)

Professional experience in committee posts:
• Founding member and secretary, ISoP UK and Ireland Chapter (2022-2025)
• ISoP Student Group Coordinating Committee Member (2023-Present)
• ISoP Annual Meeting 2023 Scientific Committee member
• ISoP Mid-Year Meeting 2026 Scientific Committee member
• Academic Lead, Global Health Impact Hub, University of Birmingham
• Advisory Board Member, CEPI-Funded SPEAC Activity on Landscape Assessment of Active Safety
Surveillance of Vaccines in LMIC
• Former Advisor Board Member, Global Antimicrobial Stewardship Partnership Hub

Your vision for pharmacovigilance:
Pharmacovigilance must evolve into a globally representative field, amplifying underrepresented voices and
integrating diverse perspectives at the highest levels of decision making. As the digital transformation
accelerates, we must close, not widen, existing capacity gaps and commit to equitable safety monitoring
worldwide. ISoP should lead this charge, promoting health equity, serving as a trusted voice for all sectors,
and championing greater inclusion of pharmacovigilance at the highest levels of public health debate.

Reasons for standing for election and what you can you do for ISoP:
I have been an active member of ISoP since 2018, and have benefited first-hand from the inclusive,
supportive spirit of the society and the remarkable opportunities it offers. During this time, I have
developed a profound appreciation for ISoP’s global impact and am dedicated to supporting its continued growth and success. If elected, I will bring robust scientific expertise, a commitment to widening collaboration, and an inclusive global perspective to the society’s leadership. I have proven leadership experience, having coordinated global public health initiatives with the WHO and international health research funders, and lead a global network of pharmacovigilance stakeholders (Global Pharmacovigilance, >10,000 members worldwide), which can be harnessed to elevate ISoP’s visibility and welcome broader membership. Moreover, my active participation across ISoP chapters and SIGs grounds me in the needs of the society membership, making me well placed to ensure a member-led approach to ISoP’s leadership.

Nationality: British

Qualifications:
1. PhD in Clinical Pharmacology, University of Manchester, 1995-1997.
2. MSc in Clinical Pharmacology (by research), University of Manchester, 1993-1995.
3. BSc Hons in Pharmacy, University of Sunderland, 1988-1991.
4. Fellow of International Society of Pharmacovigilance Since Oct 2019.
5. Fellow of Faculty of Public Health, Royal Colleges of Physicians of the UK Since March 2021.
6. Fellow of the Royal Pharmaceutical Society of Great Britain Since July 2012.
7. Honorary Fellow of Royal College of Paediatrics and Child Health Since April 2011

Professional experience:
1. Regius Professor of Pharmacy, Aston University, UK (2025-Present).
2. Lo Shiu Kwan Kan Po Ling Endowed Professor in Pharmacy, Department of Pharmacology and
Pharmacy, University of Hong Kong (HKU), Hong Kong (2018 – 2024).
3. Chair Professor of Pharmacy Practice and Medicine Evaluation Research, Department of Practice and
Policy, School of Pharmacy, University College London (UCL), UK (2015-2018).
4. Pharmacovigilance Officer at the former Medicines Control Agency (currently Medicines and
Healthcare Products Regulatory Agency), UK (1992 – 1993).

Professional experience in committee posts:
1. Member of Pharmacy and Poisons Board of Hong Kong (Regulatory Authority of Hong Kong) (2012 to
2015 and 2019 to 2025).
2. Member of Independent Scientific Advisory Committee (ISAC) for Clinical Practice Research Datalink
(CPRD) of UK Medicines and Healthcare Products Regulatory Agency (MHRA) (2016-2021).
3. Vice-President of ISoP and member of ISoP Advisory Board (2016-2019).
4. Member of Attention Deficit Hyperactivity Disorder (ADHD) Guideline Group. National Institute for
Health and Clinical Excellence (NICE) (2007-2009 and 2016-2018).
5. Member of Epilepsy Guideline Group. National Institute for Health and Clinical Excellence (NICE)
(2010-2011).

Your vision for pharmacovigilance:
My vision is to establish pharmacovigilance (PV) and ISoP as the global leader in PV, fostering innovation
and setting standards of excellence. ISoP’s work will enhance public awareness, refine regulatory
frameworks, and advocate for the safe use of medicines worldwide. Its educational programmes and
guidelines will become foundational tools for advancing practice and research in PV, inspiring
collaborative efforts to improve patient safety and revolutionize healthcare systems on a global scale.

Reasons for standing for election and what you can you do for ISoP:
As a passionate advocate for pharmacovigilance (PV), I am dedicated to advancing the science and
practice of PV to promote the safe use of medicines. ISoP is a global organization that shares this vision,
hence the reason I am standing for election—to bring my PV experience and expertise to support ISoP in
achieving its goals. As a member of the advisory committee of ISoP, I will foster collaboration and
innovation to address critical challenges in PV. By leveraging my research and practical expertise in PV, I
aim to 1) Work with ISoP members and patient groups to develop strategies and lead actions that
enhance public understanding of PV. 2) Collaborate with ISoP members and regulatory authorities to
strengthen regulatory frameworks in PV. 3) Partner with ISoP members and educational organizations to
create training programmes and support research initiatives aimed at advancing scientific knowledge and
competencies in PV.

Nationality: Jordanian

Qualifications:
Bachelor degree in pharmacy from university of Jordan
Mini Mba from Cambridge
German board in GMP in Pharma industry

Professional experience:
Certified QMS ISO consultants for more than 13 years , & certified Pharmacovigilance professional certified
Certified trainer , has an ability to implement the QMS ISO 9001 , 22000 , risk management , 45001 , medical devices in all industries and organization , ability to implement and train and raise awareness about PV system
For all pharma industries , health authorities and anyone interested .

Professional experience in committee posts:
Collaborating with regulatory authorities and other stakeholders to improve reporting systems and raise awareness about PV, as i participated in many international summits , conferences & exhibition
These committee roles helped strengthen the overall PV system and ensure patient safety, particularly in high-risk populations like women and children

Your vision for pharmacovigilance:
My vision in pharmacovigilance is to contribute to building a proactive, patient-centered safety culture that ensures the safe and effective use of medicines across all populations — especially vulnerable groups like women, children, and the elderly. I aim to advance PV practices through strategic risk management, continuous education, and system strengthening, integrating real-world evidence and digital innovation to support timely and accurate decision-making. Ultimately, I strive to make pharmacovigilance not only a regulatory requirement, but a core value embedded in all levels of healthcare and pharmaceutical practice .

Reasons for standing for election and what you can you do for ISoP:
I am standing for election to contribute meaningfully to the global advancement of pharmacovigilance through ISoP’s collaborative platform. With over 13 years of experience in pharmacovigilance, quality management, and patient safety—particularly in low- and middle-income countries—I recognize the critical need for capacity building, knowledge sharing, and inclusive representation in the field. I believe that serving on ISoP’s leadership team will allow me to advocate for underrepresented regions, promote safer use of medicines, and support initiatives that enhance PV systems globally

What I can do for ISoP

● I will work to amplify voices from the MENA region and other underrepresented communities in ISoP’s agenda and activities.

● I bring experience in multi-stakeholder coordination between regulatory authorities, hospitals, academia, and industry, and can foster strategic partnerships.

● I’m committed to promoting the integration of digital tools and real-world data in PV practice to enhance signal detection and patient engagement.

● I will advocate for greater research, awareness, and system strengthening to address the unique challenges in pharmacovigilance for women and children.

Nationality: Swedish

Qualifications:
Medical doctor, clinical pharmacologist. Master of Science in Pharmacology; PhD and Associate professor in clinical pharmacology. Senior PV Expert. Awarded a Fellowship with ISoP (FISoP).

Professional experience:
My principal areas of expertise: Pharmacovigilance, Pharmacogenetics, Clinical Pharmacology, Drug regulation
I am currently a Senior PV Expert at the Uppsala Monitoring Centre (UMC). Prior to joining the UMC, I worked at the Swedish Medical Products Agency for more than 20 years.
I have a long career path in academia, regulatory science and public health through the UMC, with over 35 years of experience in pharmacology and pharmacovigilance in Chinese, European and international positions. Within the EU regulatory network I have been active in many of the routine PV procedures (e.g. PSURs, RMPs, Referral, PASS protocols or results, and drug safety signals) as a medical assessor or PRAC Rapporteur.
I have published more than 70 scientific papers, with 25 articles published in the last ten years. The research works were mainly within clinical pharmacology, pharmacogenomics, and pharmacovigilance with new signals and signal management in recent years.
I have actively contributed to ISOP training and meetings related to pharmacovigilance and pharmacogenomics, and my Chinese language knowledge also brings a contribution to ISoP skillset. I actively lead the Pharmacogenomics SIG in ISoP.

Professional experience in committee posts:
Member of Pharmacovigilance Working Party (PhVWP) 2010 – 2012.
Members of Pharmacovigilance Risk Assessment Committee (PRAC) at EMA 2012-2018.
Member of the Pharmacogenomic Working Party (PGWP) at EMA 2009 -2018.
Chairperson of the Pharmacogenomics (PGx) SIG of ISOP since 2020.
Member of the CIOMS XII Working Group on “Benefit-Risk Balance for Medicinal Products” (recently finalized in 2025).

Your vision for pharmacovigilance:
Global collaboration- enabling real-time signal detection everywhere.
Patient-centered- putting the needs, experiences and voice of patients at the heart of drug safety.
Personalised risk management- integrating genetic data into risk management plan.
Continuous Learning Systems- feeding the updated drug safety profiles back into different stake holders.
Proactive- using AI and machine learning to detect patterns and predicting potential adverse effects early

Reasons for standing for election and what you can you do for ISoP:
As an Advisory Board member I hope to bring to ISoP my areas of expertise in pharmacovigilance, pharmacogenomics, clinical pharmacology and regulatory science as well as my enthusiasm and energy. Together with other ISoP Advisory Board members foster pharmacovigilance both scientifically and educationally and enhance all aspects of the safe and proper use of medicines, in all countries. I am willing to help ISoP develop further as a robust, professional, and leading pharmacovigilance society.

Nationality: Egyptian

Qualifications:
• Bachelor of Pharmacy, Helwan University, Egypt (2006)-
• Winner of GCC AWARD in Pharmacovigilance 2023
• RAPS-Certified Regulatory Affairs Professional – Medical Devices (2024)
• Qualified Person for Pharmacovigilance (QPPV)
• ISO 9001:2015 Lead Auditor
• Completed 20+ advanced training courses in pharmacovigilance, signal detection, device vigilance, risk minimization, and regulatory frameworks (EU, GCC, MENA)

Professional experience:
• Regulatory Affairs & Product Quality Supervisor – Middle East
Fresenius Medical Care, UAE (2022-Present)
Lead PV, RA, and QMS operations for medical devices across 16 Middle East countries.
• QPPV, Regulatory Affairs & Quality Manager
Advanced Technology Company, Kuwait (2018-2022)
Oversaw PV for 30+ multinational companies; developed distributor PV networks; conducted FSCA coordination, safety data management, and audits.
• QPPV & Drug Safety Officer
Mohamed Naser Alhajery & Sons, Kuwait (201-2018)
Set up PV systems and ensured compliance for 20+ MAHs; handled ICSRs, PSURs, and regulatory correspondence.
• Regulatory Affairs Manager @ Nutraceuticals
Health House, Kuwait (2018-2019)
Managed product registration and regulatory expansion in GCC.
• QPPV @ Bahrain Pharma, Egypt (2016-2018)

Professional experience in committee posts:
• Active member of ISoP, RAPS, and Mecomed Regulatory Committee

Your vision for pharmacovigilance:
Pharmacovigilance is more than compliance -it is a regional safety culture.
I aim to empower distributors as PV champions through multilingual training and digital tools.
I’ll promote a Middle East PV Harmonization Charter, aligning GCC/Levant practices.
I’ll support AI-based vigilance platforms to accelerate signal detection and response.
PV must become part of every function – from receptionists to regulators – ensuring safety at all touchpoints.

Reasons for standing for election and what you can you do for ISoP:
As a passionate PV leader with over 15 years of experience, I offer cross-sector and cross-regional insights.
I aim to amplify ISoP’s presence in the Middle East and foster PV awareness in Arabic-speaking regions.
My bilingual background and cultural knowledge help bridge global PV standards and local realities.
I will initiate PV education hubs and digital mentorship programs through ISoP.
I bring strong expertise in GVP, device vigilance, risk communication, and quality systems.
I will work to create scalable PV frameworks adapted for low-to-middle-income countries.
I propose webinars and practical case studies to support HCPs, regulators, and companies.
I will promote ISoP collaboration with universities, ministries, and industry networks.
I am committed to diversity, outreach, and innovation in PV practice.
Together, we can empower the next generation of global PV professionals.

Nationality: Lebanese

Qualifications:
I hold a Doctor of Pharmacy (Pharm.D.) from Lebanese American University, and a
Master’s in Patient Safety from MCPHS University in the U.S., along with certification in
Medication Safety. I am currently a PhD candidate in Public Health at Université Grenoble
Alpes in France, focusing on pharmacovigilance systems in resource-limited settings.

Professional experience:
My career spans over two decades in pharmacy education, clinical practice, and national
pharmacovigilance management. I served as Clinical Assistant Professor at the Lebanese
American University School of Pharmacy (2001–2015), Clinical Pharmacist in Medication
Safety at LAUMC-RH (2012–2015), and currently serve as Senior Clinical and Technical
Manager of the Lebanese National Pharmacovigilance Program at the Lebanese Ministry
of Public Health since 2021 .

Professional experience in committee posts:
I have held numerous academic and national committee roles including:
Chair, Medication Safety Committee (LAUMC-RH)/ Chair and Secretary, Research
Council (LAU)/ Member, Strategic Planning and Accreditation Committees (LAU)/
Member, Colloquium Exam Jury/ Member, Financial Aid, PAC, and University Senate
(LAU).

Your vision for pharmacovigilance:
My vision is to institutionalize pharmacovigilance within national health systems by
integrating it into regulatory frameworks and public health agendas. I believe in a
proactive, data-driven approach that empowers healthcare professionals, engages
patients, and ensures safe medication use. Through international collaboration, capacity
building, and digital tools, pharmacovigilance can transform into a cornerstone of patient
safety and healthcare quality in all countries; especially those with limited resources .

Reasons for standing for election and what you can you do for ISoP:
I am standing for election to bring the perspective of a developing country successfully
implementing a national pharmacovigilance program under complex constraints. I believe
ISoP can play a critical role in harmonizing safety standards globally while adapting them
to local realities. With my dual background in academia and health system leadership, I
can contribute to expanding ISoP’s training initiatives, nurturing regional collaboration,
and supporting capacity-building in underserved settings. I aim to promote inclusion,
innovation, and policy translation across member states. Through strategic projects,
publications, and advocacy, I will support ISoP’s mission to embed pharmacovigilance into
every healthcare system for the benefit of all patients.

Nationality: Swedish

Qualifications:
Pharmacist with a Master’s degree in Drug Discovery and Development from Uppsala University.

Professional experience:

• Signal management assessor: 2013-2014 Uppsala Monitoring Centre (UMC)
• Team Manager: 2014–2015 UMC
• Research Pharmacist: 2015-2022 UMC
• Senior Pharmacovigilance Scientist 2022- Present UMC

I have over a decade of experience contributing across several key areas within global pharmacovigilance
at Uppsala Monitoring Centre. My work has primarily focused on signal management and
pharmacovigilance research, with a strong emphasis on method development to enhance the
identification and understanding of medicine safety concerns. I have led and supported international
initiatives aimed at improving signal detection processes and strengthening global pharmacovigilance
systems. A core part of my role involves developing tools and approaches that address real-world needs
and challenges in medicine safety, with the goal of improving safety monitoring and decision-making.

I have a particular passion for addressing medication errors and preventable harms, and I have held a
dedicated focus and responsibility in this area throughout my career—both within UMC and through my
involvement with the International Society of Pharmacovigilance (ISoP).
I have also worked closely with national regulatory authorities around the world to support the
development and sustainability of effective national pharmacovigilance centres.
Earlier in my career, I gained valuable experience in retail pharmacy and clinical trial operations, which
continues to shape my comprehensive and practical approach to medicine safety.

Professional experience in committee posts:
• Project Manager, International Society of Pharmacovigilance (ISoP) Medication Error Special
Interest Group: 2020-2021
• Scientific Committee Member – ISoP Annual Meeting 2025

Your vision for pharmacovigilance:
As a passionate pharmacovigilance professional, I envision a globally connected ISoP that advances the
safer use of medicines and vaccines through innovation and collaboration. By fostering a vibrant and
inclusive community, we can empower members through continuous learning and shared knowledge.
Strategic growth and meaningful outreach will help ensure ISoP’s resilience and global relevance. I am
committed to strengthening member engagement and creating opportunities for professional
development. Together, we can build a safer, more effective healthcare system – for everyone,
everywhere.

Reasons for standing for election and what you can you do for ISoP:
I am honored to stand for election to the ISoP Advisory Board to help shape a safe and inclusive global
pharmacovigilance community.
As a Swedish pharmacist with proud African heritage, I bring a unique cross-cultural perspective that
reflects the diversity of the global health landscape. With over a decade of experience— from signal
management to supporting national regulatory pharmacovigilance systems—I offer strategic insight
grounded in both scientific rigor and cultural awareness.
My passion for education, mentoring, and innovation drives my commitment to strengthening ISoP’s
scientific and professional impact. I aim to expand access to training, foster collaboration, and support
members across all regions, especially those underrepresented in global health dialogues.
As a long-standing ISoP member, I deeply value our shared mission and the strength of our diverse
community. I will work to ensure ISoP remains resilient, forward-looking, and responsive to evolving
healthcare needs. Pharmacovigilance is not just my profession—it is my dedication. Together, we can
advance the safe use of medicines and vaccines worldwide. I am ready to lead, serve and shape ISoP’s
next chapter.