ISoP Mid-Year Symposium

Dr Stella Blackburn. MB BS, MA, MSc, FRCP(Ed), FISPE, FFPM, DLSHTM, Dip.Pharm.Med.
Stella studied medicine at Cambridge and Guys and worked in hospital medicine before joining the pharmaceutical industry. She has worked in pharmacovigilance and pharmacoepidemiology for 35+ years: in industry (11+ years) as a regulator (nearly 17 years) and CRO (9 years). She has an MSc in Epidemiology from the London School of Hygiene and Tropical Medicine and co-developed, and still teaches on, their course in Pharmacovigilance and Pharmacoepidemiology. In 1997 she joined the European Medicines Agency (EMA). Stella was EMA lead in developing EU strategy and policy on risk management, writing the EU guidelines on this topic and was part of the core team implementing the 2010 PhV legislation. She was on the original steering group developing ENCEPP and was the Alternate Co-ordinator, and a scientific work package leader, of IMI PROTECT. Whilst at IQVIA she advised companies on EU strategy, Post Authorisation Safety Studies and risk management with a special interest in rare diseases.
Stella is currently CIOMS President and a member of the CIOMS Glossary Advisory Group. She participated in the CIOMS IX/XI/XIII working parties.
Stella is a Fellow of the International Society of Pharmacoepidemiology (ISPE), the Royal College of Physicians of Edinburgh, and the Faculty of Pharmaceutical Medicine. She is a past President of ISPE, an Honorary Professor at the LSHTM and was a Visiting Scientist and then Senior Regulatory Advisor at NEWDIGS, Center for Biomedical System Design at MIT and Tufts.

Tom started his industry career in medical information, but soon realised that his passion was for pharmacovigilance (PV). He has worked across the full PV spectrum from early phase clinical trials through to generics. Following a period heading up the PV function at a leading clinical research organisation (CRO), he decided to launch Drive Phase PV, with the goal of providing high-quality and personalised PV support to clients around the world.
He is an Honorary Fellow of Pharmaceutical Information and Pharmacovigilance Association (HonFPIPA) and has served on the committee since 2013, included as President from 2020- 2022.

Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency
(MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a
BSc (Hons) and PhD from the University of London and has extensive academic and regulatory
experience, including roles at both the European Medicines Agency and at the MHRA. Her previous
positions include Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust
and an Industrial Strategy Challenge Fund Director at UK Research and Innovation.

Professor Sam Salek
PhD RPh FFPM/RCP GFMD FRPS FESCP MCMS
Sam Salek is Professor of Pharmacoepidemiology and Regulatory Science in the School of Life and Medical Sciences, University of Hertfordshire, UK where he leads the Public Health & Patient Safety research group. He is also the Director of the Institute for Medicine Development, Cardiff, UK, Vice-President of PharmaTrain Federation and a visiting Professor at the State of Hessen, Germany. Professor Salek is the founder and past chair of the Patient Engagement Special Interest Group of the International Society of Quality of Research, co-chairs the European Hematology Association (EHA) Scientific Working Group for Quality of Life and Symptoms and chairs the EHA SWG ‘Gaucher’s Disease Task Force’.
Professor Salek completed his undergraduate degree at the University of Oklahoma, USA in 1978. He later moved to Cardiff, United Kingdom where he studied for his PhD, 1985–1989. Since completing his PhD, Professor Salek has held a number of academic posts on both sides of the Atlantic. His major research interests are: development, evaluation and application of instruments to assess patient-reported outcomes and health-related quality of life (HRQoL); pharmacoeconomics/ health economics, benefit-risk assessment of medicines; medicine profiling; and pharmaceutical regulatory science to improve patient access to new medicines.
Professor Salek has developed a few undergraduate, postgraduate diploma and MSc courses over the past 40 years which they continue to be successful. Of noteworthy: he developed and modernised the 2-year part-time Postgraduate Course in Pharmaceutical Medicine (Dip Pharm Med) and was the Course Director for 30 years; he is the founder of the MSc in International Pharmaeconomic & Health Economics in 2006 and was the Programme Director until 2015; he is the founder of the Integrated Master of Regulatory Science (an undergraduate programme) which received approval from the University of Hertfordshire Validation Board in April 2017 and commenced in September 2018.
Professor Salek is a fellow of the Royal College of Physicians, the Royal Pharmaceutical Society, Cardiff Medical Society, the European Society of Clinical Pharmacy and Global Fellow of Medicine Development. He is a member of five Editorial boards and has published 20 books and over 750 journal articles and abstracts. He has developed and validated 11 general and disease-specific patient-reported outcome (PRO)/health-related quality of life (HRQoL) measures, whilst also collaborating with the pharmaceutical industry to design HRQoL protocols for clinical trials. Increasingly, Professor Salek is shifting his emphasis towards the practical applications of patient-reported outcome measures in clinical/policy decision-making and patient engagement in research as partners/collaborators as well as family reported outcome measures (development and implementation).

Francesco Salvo is a Full Professor of Pharmacology at the Medicine School of the University of Bordeaux.
It’s been around 20 years he’s working in drug safety, first at the Sicilian centre of Pharmacovigilance in Messina, Italy, then the nationwide Italian network of regional PV centres, and in the signal detection group of the Italian Medicine Agency (AIFA).
In 2008 he moved to Bordeaux where he has been involved in pharmacoepidemiology research projects funded by European Commission.
From 2014 to October 2020, he assessed safety of clinical trial sponsored by the Bordeaux University Hospital, and he was involved in real-life safety studies conducted by the French platform “Drugs-Safe”, supported by the French Medicine Agency (ANSM).
In 2017, he started the coordination of the European Programme of Pharmacovigilance and Pharmacoepidemiology (Eu2P), and since 2021 he leads the Bordeaux Regional Pharmacovigilance Centre.
Professor Francesco Salvo currently serves as Vice President of the International Society of Pharmacovigilance (ISoP).

Dr Ryan Walker is a registered pharmacist and Assistant Professor of Clinical Pharmacy at the School of Pharmacy, University of Birmingham, UK. With a background in research systems strengthening, his work focuses on strengthening medicines safety research and practice in low resource settings. His current research explores barriers to participation in postgraduate pharmacovigilance education opportunities, improving pharmacovigilance data access, medicines safety during health emergencies, and strengthening methods of knowledge exchange. Since 2018, he has coordinated Global Pharmacovigilance, an open access online knowledge hub and community of practice dedicated to supporting pharmacovigilance research in low- and middle-income countries. In addition, he is outgoing secretary of the ISoP UK and Ireland Chapter, an Advisory Group member of the ISoP Student Group, and member of the ISoP European Chapter interim steering committee.

Miranda qualified from Southampton University Medical School in 1995. She completed clinical posts in a variety of hospital specialties (Psychiatry, Elderly Care, Obstetrics and Gynaecology, Palliative Medicine) before joining the DSRU in 2002. She provides clinical support across a range of pharmaco-epidemiological studies and is actively involved in teaching, facilitating and course organisation through DSRU Education and Research Limited. She has presented at international conferences and published papers in peer reviewed journals. Miranda holds the Diploma in Pharmaceutical Medicine and is a Member of the Faculty of Pharmaceutical Medicine (MFPM) of the Royal College of Physicians.

Dr Harriet Scorer MB BS FFPM
Harriet is a pharmaceutical physician with over 30 years’ experience working in the pharmaceutical industry. Her roles have included clinical trials, pharmacovigilance, medical and regulatory affairs, and senior management as a Medical Director.
She is Chair of WMUK. A charity which supports patients with Waldenstrom’s Macroglobulinaemia (WM) to live longer, better quality lives.
WM is a rare and incurable low grade non Hodgkin lymphoma. Although therapeutic options are expanding there is no consensus on the preferred approach with patients having to make difficult choices regarding potentially toxic treatments.
Harriet herself has WM and over the years has had many treatments, some easier to tolerate than others. She is currently participating in a clinical trial. Her background places her in a unique position to ask the question ‘Is pharmacovigilance delivering for patients?’

Sylvia Layton, P.Eng., C.Eng., F.I.Chem.E., CRM, is a risk engineering and process safety specialist with over 35 years of experience in operational risk assessment across the oil, gas, petrochemical, power, and industrial sectors. She began her career in the mid-1980s at Exxon’s Fawley refinery in the UK; one of the few women in a front-line technical role at the time. Since then, she has conducted hundreds of risk assessments at industrial facilities across the UK, Europe, the U.S., and Canada. Sylvia is a Fellow of the Institution of Chemical Engineers, a designated Process Safety Engineer through the IChemE, a licensed Professional Engineer in British Columbia, and holds a Certificate in Risk Management from the Insurance Institute. Her assessments support risk-informed decisions in insurance underwriting and promotes best practices in process safety and operational risk management.

Uwe Riek PhD
Master (Diplom), Environmental Natural Sciences, ETH Zürich, Study-focus on Chemistry, Earth System, Natural Perils & Risk. Ph.D., from Inst. of Cell Biology, ETH Zürich. Field of work: Biochemistry, Biophysics & Automation. >10y experience as trainer and consultant for system administration and architecture (UNIX, Linux, high availability systems & networks). 3 years consultant at Swisscom for business continuity, disaster recovery, scenario-based risk analysis for high availability systems and networks. Since 14 years risk engineer at Swiss Re for various industries (Chemistry, Pharma/Biotech, Telecom, Dams & Hydropower, Mining & general property) strongly involved in risk quantification method development.

Bruce Fitt is Emeritus Professor of Plant Pathology at the University of Hertfordshire. He led a Crop Protection and Climate Change research group, with two Professors, one Reader, four postdoctoral research fellows, seven PhD students and several MSc students, until July 2023. He also led the University of Hertfordshire Research Excellence Framework submission to the UK government on Agriculture, Food and Veterinary Sciences in 2014 and 2021. He was a member of the research executive group of the School of Life and Medical Sciences. He was co-leader of the Centre for Agriculture, Food and Environmental Management University Research Centre.
Research highlights. New insights into operation of resistance against hemibiotrophic crop pathogens (Huang et al. 2006; Boys et al. 2012). Demonstrated that crop disease control contributes to climate change mitigation (reduced GHG from agriculture, Mahmuti et al. 2009; Fitt et al. 2011; Hughes et al. 2011). Research on impacts of climate change on crop diseases (Evans et al. 2008; Butterworth et al. 2010) presented at House of Lords (2010). Use of quantitative PCR in analysis of 160-year Rothamsted archive samples to produce new theories about wheat septoria diseases (Bearchell et al. PNAS, 2005; Shaw et al. 2008) and with spore sampling to forecast disease epidemics (West et al. 2008; Van de Wouw et al. 2010). Web-based versions of forecasts for oilseed rape diseases (e.g. Welham et al. 2004; Stonard et al., 2010) widely used by UK industry (since 1996).

Dr. Eileen Dareng, MD, MPH, PhD is a clinically trained pharmacoepidemiologist with over a decade of experience in conducting observational studies, including pregnancy-related research to address regulatory requirements. Having held key roles in various biopharmaceutical industry settings, Dr. Eileen Dareng has led and contributed to numerous pregnancy studies, playing a pivotal role in the design, execution, analysis and implementation of innovative approaches in these studies, ensuring regulatory acceptability.
Currently serving as a Director of Safety Epidemiology at AstraZeneca, Eileen Dareng provides overall scientific oversight and strategic development for a wide array of observational studies, contributing to the advancement of knowledge in the field of pregnancy research and pharmacovigilance.

Dr Anne Broe Lambourne, MD, PhD, is a UK-based pharmacoepidemiologist with over 10 years of experience in designing and conducting multi-country retrospective observational studies for both regulatory and non-regulatory purposes. Anne is an Associate Director of Epidemiology at IQVIA, as well as a guest researcher at University of Southern Denmark. Dr Lambourne is actively involved in the International Society for Pharmacoepidemiology Special Interest Group and has led a global alignment initiative for pregnancy studies in real world evidence.

Professor Deborah Layton FRPharmS, FISPE, PhD is a UK-based pharmacoepidemiologist and pharmacovigilance expert with over two decades’ experience in medicines safety, real-world evidence and regulatory decision support. She is Chief Scientific Officer at PHARMO, part of Lumanity and founder of PEPI Consultancy Ltd, providing senior advisory input on post-authorisation safety studies, risk management and evidence governance. She is an honorary professor at University of Hertfordshire, is widely published and has previously held executive leadership roles, with responsibility for oversight of large, complex post-marketing safety programmes using routine healthcare data.

Dr Céline Caillet is the Deputy Head of the Medicine Quality Research Group (MQRG) of the Infectious Diseases Data Observatory, MORU Tropical Health Network and the Center for Tropical Medicine and Global Health of the University of Oxford. She is a pharmacist and former resident of the Hospital of Toulouse. Following her MSc in Epidemiology and Public Health in Bordeaux, France, Céline completed her PhD in drug safety in Laos. Before joining the MQRG team, she did research on drug safety at the Regional Center of Pharmacovigilance of Toulouse, France. She also taught pharmacology at the Faculty of Medicine of Toulouse, and during her PhD in the Department of Pharmacy at the University of Health Sciences, Vientiane. She joined the MQRG team in 2015, then based in Laos and is now based in Oxford, UK. She is particularly interested in the epidemiology of substandard and falsified medicines, innovative technologies to investigate falsified medicines cases, and testing the performances of screening technologies for early detection of substandard and falsified medicines.

With more than 25 years of experience in healthcare analytics, biostatistics, data management, business consulting, and thought leadership, Sarah Seager has led strategy, delivery, product development, and technical initiatives across the Healthcare and Life Sciences sector. She has built a career on driving innovation and improving operational efficiency, consistently championing data driven approaches that enhance patient outcomes and advance the value of real world evidence in healthcare.

Andrej Segec MPharm MSc is originally from Slovakia and a pharmacist by training (Comenius University, Bratislava, Slovakia) with an MSc in Epidemiology (London School of Hygiene and Tropical Medicine, London, UK). He has worked for the European Medicines Agency (EMA) since 2008, holding a number of roles in pharmacovigilance, signal detection and signal management, monitoring of the performance of the EMA pharmacovigilance system, in surveillance and epidemiology, as committee manager for the operations of the Pharmacovigilance Risk Assessment Committee (PRAC) and as a risk management specialist for anti-infective therapies and vaccines during the COVID-19 pandemic.
In the current role, Andrej’s focus is on the generation and use of real world evidence in regulatory decision making and the operation of the Data Analysis and Real-World Interrogation Network (DARWIN EU®).

Dr Nivantha Naidoo, MBChB, MPH Epi, MSc Comparative Research, is a Paris-based pharmacoepidemiologist, methodologist and certified physician with 15 years’ experience across EU and global healthcare, specializing in technology-enabled real-world data analytics and real-world evidence generation. She is currently a Principal at Oracle Life Sciences, where she leads integrated evidence generation strategy and delivers consulting solutions across the product lifecycle. She has expertise spanning evidence synthesis including living methods, secondary data analytics including registry plug-in and primary ‘direct-to-participant’ studies including Delphi technique. She is an active scientific contributor, and conference faculty/member in ISPE/ISPOR communities, with leadership roles. Bilingual in English and French, she combines methodological rigor with pragmatic, stakeholder-focused delivery for regulators, HTA/payers, and industry decision-makers.

Dr Ben Bray MBChB MD MSc FBCS
Ben is an epidemiologist and physician who has been working in real world evidence for over fifteen years. His career spans academia and industry, across health services research, epidemiology and health data science, and he has authored over 75 publications including in leading journals such as The Lancet, BMJ and PLOS Medicine. He has a specialist interest in applied applications of AI, and co-chairs the generative AI working group at ISPE. He currently leads the real world evidence practice area at LCP, and is an honorary senior clinical lecturer at King’s College London and member of the Indicator Advisory Committee at NICE.

Pav is a visionary healthcare leader with over 25 years of working experience in Pharmacovigilance (PV), holding global senior management roles including regional and local. He is currently Head of Pharmacovigilance at Celltrion Inc. and has chaired the UK ABPI Pharmacovigilance Expert Network (PEN) for over eight (8) years where he also served as a Board Steering Group member. Recognised as a credible industry thought leader, he was awarded “PV Thought Leader of the Year” at the International Awards of Excellence. Pav actively contributes to global PV initiatives, ISoP, and regulatory forums, shaping national guidelines and patient safety strategies. He is known for purposeful leadership, empowering teams, and influencing policy, including contributions to the UK Government’s Lord Patrick Vallance Review.

Professor Deborah Layton FRPharmS, FISPE, PhD is a UK-based pharmacoepidemiologist and pharmacovigilance expert with over two decades’ experience in medicines safety, real-world evidence and regulatory decision support. She is Chief Scientific Officer at PHARMO, part of Lumanity and founder of PEPI Consultancy Ltd, providing senior advisory input on post-authorisation safety studies, risk management and evidence governance. She is an honorary professor at University of Hertfordshire, is widely published and has previously held executive leadership roles, with responsibility for oversight of large, complex post-marketing safety programmes using routine healthcare data.

Pav is a visionary healthcare leader with over 25 years of working experience in Pharmacovigilance (PV), holding global senior management roles including regional and local. He is currently Head of Pharmacovigilance at Celltrion Inc. and has chaired the UK ABPI Pharmacovigilance Expert Network (PEN) for over eight (8) years where he also served as a Board Steering Group member. Recognised as a credible industry thought leader, he was awarded “PV Thought Leader of the Year” at the International Awards of Excellence. Pav actively contributes to global PV initiatives, ISoP, and regulatory forums, shaping national guidelines and patient safety strategies. He is known for purposeful leadership, empowering teams, and influencing policy, including contributions to the UK Government’s Lord Patrick Vallance Review.

Dr. Michael Forstner has 25 years industry experience in various roles in R&D and drug safety in different pharmaceutical companies and as a consultant and has contributed to several successful marketing authorizations of innovative medicines by developing workable, efficient benefit-risk management measures, mostly in the oncology and CNS therapeutic areas. He is currently driving the utilization of RWE and AI in pharmacovigilance processes and their integration with digital health processes, as well as methodologies to develop and maintain favourable benefit-risk frameworks informed by patient preferences. Another focus is on the development of graphical representations of risks associated with ADRs to enable improved patient decision making.

Linda Härmark, PharmD, MEpi, PhD, MBA
Dr. Linda Härmark has over 20 years of experience in pharmacovigilance, spanning research, strategic leadership, and international collaboration. She began her career at the Netherlands Pharmacovigilance Centre Lareb, where she held senior roles including Head of Innovation and Deputy Director. Currently, she is Director of the Drug Safety Research Unit, leading studies on medicine and vaccine safety using real-world data.
She is passionate about patient involvement in pharmacovigilance, where she has conducted research and contributed to CIOMS XI’s report on patient involvement. She is committed to advancing pharmacovigilance in LMICs, having coordinated the WHO Collaborating Centre for Patient reporting and Education in PV and served on the executive board of the EDCTP-funded PAVIA project.
Linda has (co-)authored over 50 peer-reviewed publications. She serves on the steering committee of the European Chapter of ISoP bringing scientific depth and strategic insight to the evolving field of drug safety.

Omar Aimer is a pharmacologist based in Montreal, Canada, with extensive expertise in pharmacovigilance and drug safety. He currently serves as President of the International Society of Pharmacovigilance (ISoP) for the 2025–2028 term and is the Founder of InnoVigilance.
Omar has held roles at the Regional Pharmacovigilance Centers in France and the LNCPP (now ANPP) in Algeria, and has lectured at the Universities of Algiers, Oran, Versailles, and Essen. He has also contributed to the pharmaceutical industry across Europe and Canada.
He holds a Pharmacy degree and a PhD in Pharmacology from the University of Algiers, a Master’s in Pharmacovigilance and Drug Safety from Paris Descartes University, and a Certification in Global Health with a focus on safety and quality from Harvard University.
Omar has presented widely at scientific forums and authored numerous peer-reviewed publications, with special interests in emerging technologies, medical device safety, and advancing pharmacovigilance practices globally.

Professor Sam Salek
PhD RPh FFPM/RCP GFMD FRPS FESCP MCMS
Sam Salek is Professor of Pharmacoepidemiology and Regulatory Science in the School of Life and Medical Sciences, University of Hertfordshire, UK where he leads the Public Health & Patient Safety research group. He is also the Director of the Institute for Medicine Development, Cardiff, UK, Vice-President of PharmaTrain Federation and a visiting Professor at the State of Hessen, Germany. Professor Salek is the founder and past chair of the Patient Engagement Special Interest Group of the International Society of Quality of Research, co-chairs the European Hematology Association (EHA) Scientific Working Group for Quality of Life and Symptoms and chairs the EHA SWG ‘Gaucher’s Disease Task Force’.
Professor Salek completed his undergraduate degree at the University of Oklahoma, USA in 1978. He later moved to Cardiff, United Kingdom where he studied for his PhD, 1985–1989. Since completing his PhD, Professor Salek has held a number of academic posts on both sides of the Atlantic. His major research interests are: development, evaluation and application of instruments to assess patient-reported outcomes and health-related quality of life (HRQoL); pharmacoeconomics/ health economics, benefit-risk assessment of medicines; medicine profiling; and pharmaceutical regulatory science to improve patient access to new medicines.
Professor Salek has developed a few undergraduate, postgraduate diploma and MSc courses over the past 40 years which they continue to be successful. Of noteworthy: he developed and modernised the 2-year part-time Postgraduate Course in Pharmaceutical Medicine (Dip Pharm Med) and was the Course Director for 30 years; he is the founder of the MSc in International Pharmaeconomic & Health Economics in 2006 and was the Programme Director until 2015; he is the founder of the Integrated Master of Regulatory Science (an undergraduate programme) which received approval from the University of Hertfordshire Validation Board in April 2017 and commenced in September 2018.
Professor Salek is a fellow of the Royal College of Physicians, the Royal Pharmaceutical Society, Cardiff Medical Society, the European Society of Clinical Pharmacy and Global Fellow of Medicine Development. He is a member of five Editorial boards and has published 20 books and over 750 journal articles and abstracts. He has developed and validated 11 general and disease-specific patient-reported outcome (PRO)/health-related quality of life (HRQoL) measures, whilst also collaborating with the pharmaceutical industry to design HRQoL protocols for clinical trials. Increasingly, Professor Salek is shifting his emphasis towards the practical applications of patient-reported outcome measures in clinical/policy decision-making and patient engagement in research as partners/collaborators as well as family reported outcome measures (development and implementation).

Vijay Kara serves as a Director within the Safety Innovation and Analytics group, part of GSK’s Global Safety organization. He is a seasoned pharmacovigilance professional with over 15 years of experience in the field.
Throughout his career, Vijay has held various roles at multiple pharmaceutical companies, acquiring expertise in signal detection and management, risk management, and preparing regulatory submissions for new products and indications, license renewals, in addition to experience in safety governance. His contributions have led to multiple peer-reviewed publications in pharmacovigilance.

Felipe Villalobos is a medical doctor and senior researcher with dual Mexican and Spanish nationality, specializing in pharmacovigilance, pharmacoepidemiology, and health data science. At IDIAP Jordi Gol in Barcelona, he leads international vaccine safety studies, coordinates multidisciplinary teams, and drives innovative research using real-world data. He also oversees the Centres de Salut Integral de Referència (CSIR) Project, advancing integrated, high-quality primary care reform in Catalonia.

Beyond his research, Dr. Villalobos lectures at the Universitat Oberta de Catalunya and collaborates with regulators, healthcare providers, and patient organizations to strengthen global pharmacovigilance capacity. He co-coordinates the ISoP European Chapter and the Data Expert and Access Partners (DEAPs) Working Group at VAC4EU, and has served on the European Health Parliament’s Well-being for Health Care Workers Committee.

Passionate about innovation, inclusion, and mentorship, Dr. Villalobos advocates for a globally connected and equitable pharmacovigilance community that leverages data science to improve patient safety worldwide.