Advisory Board

Pharmacist, Epidemiologist, Ms Pharmaceutical Care, MsC Education. With 20 years of experience, she is an international consultant and lecturer in pharmacovigilance, safe use of medications and medical devices, patient safety, management of information sources and patient education, including standards for national and international accreditation (JCI), with experience as a teacher in the same areas. Member of Research Ethics Committees, Founding Member and Ex-President of the Colombian Pharmacovigilance Association, International Society of Pharmacovigillance (ISoP) Board Member, and ISoP Special Interest Group (SIG) “Medication errors” Co-chair. ISoP SIG Risk Communication member and ISoP President.

Founding member of Latin American Network of Human Factors and Ergonomics in Healthcare Systems (RELAESA). Currently Pharmacy Career Director in Pontificia Universidad Javeriana.

Dr Edwards trained at Guy’s Hospital, London and spent 14 years in hospital medicine and clinical research before joining the UK regulatory agency which used to be called the Medicines Control Agency. After 5 years there, he joined a global CRO, Parexel, for six years followed by 18 months at Johnson & Johnson as a deputy qualified person for pharmacovigilance.

For the last 13 years up until 2021, he was Principal Consultant in Pharmacovigilance at NDA Regulatory Science based in the UK.

In addition, he is Director of ISoP Secretariat Ltd and co-chairs the ISOP Medication Error Special Interest Group) and Chair of the UK Pharmaceutical Human Factors group. Previously, he chaired the panel overseeing the ‘Drug Safety Surveillance’ module as part of Higher Medical Training for pharmaceutical medicine in the UK between January 2006 and 2012. He has been awarded a Fellowship with the International Society of Pharmacovigilance.

Currently he is Managing Director of his own consultancy Husoteria Ltd and has been co-leader of the DIA/ASA BRAP working group since 2020. More recently, he has been elected back to the Board of ISOP and will be Vice-President on the Executive Committee.

Mónica is a clinical pharmacologist trained in pharmacovigilance. She achieved her medical degree in her home country -Ecuador- and holds a PhD. degree in Clinical Pharmacology from the Autonomous University of Barcelona. Mónica has worked in multidisciplinary groups to identify post-marketing drug safety signals at national and international level.

Since returning to Ecuador, she has worked as a lecturer of Basic and Clinical Pharmacology in some Ecuadorian universities. Monica has also served on several national committees, including the external expert panel of the Ecuadorian Regulatory agency (ARCSA) and the National Commission of Medicines in Ecuador (CONAMEI). Internationally, she has worked as a consultant for the Pan-American Health Organization and is part of the external expert panel of the Brazilian Health Regulatory Agency (ANVISA). She was part of the previous term of the ISoP Advisory Board (2019-2022).

Currently, she works as a consultant -based in Ecuador- for the Uppsala Monitoring Centre (Education and training section/Signal management team).

Omar Aimer has more than 18 combined years of experience in Pharmacovigilance, Quality Assurance and Risk Management in Pharmaceutical Industry, regulatory authority and Hospital environment in Europe and North America. He has also more than 11 years of experience in parallel as a lecturer on Pharmacology and Clinical Research.

Omar holds a Degree in Pharmacy from the University of Oran (Algeria), PhD in Pharmacology from Algiers University (Algeria), a Master in Pharmacovigilance and Drug Safety from Paris Descartes University (France) and a Certification on Improving Global Health with a Focus on Quality and Safety from Harvard T.H. Chan School of Public Health.

He has previously worked as Safety Officer at Pfizer and Pharmacovigilance Specialist at Sanofi in Montreal, Canada.

Omar is a member of the International Society of Pharmacovigilance (ISoP), Leader of the Medical Device Safety – Special Interest Group (SIG) and served on the Executive Committee as the Coordinator of Membership at North American Chapter of ISoP.

He has presented in multiple scientific forums and contribute in several per reviewed publications with interest in new technologies, regulation, and the improvement of pharmacovigilance around the world.

Dr. Mayada Alkhakany has more than 15 years of experience working within various sectors of the pharmaceutical industry having worked across a range of key areas including clinical operation, medical affairs, and pharmacovigilance functions.

She was the head of pharmacovigilance in Middle East, Turkey, and Africa (2014-2019) in Boehringer Ingelheim. She was an associate director of pharmacovigilance in Merck Sharp & Dome (2010-2014). She’s pharmacovigilance, policy making and leadership consultant.

Dr. Mayada is a member of ISoP (International Society of Pharmacovigilance), founder and Chair of ISoP patient engagement group. Co-founder and ex-president of ISoP Middle East chapter (2015-2020). She was the chair of local organizing committee of the annual meeting of ISoP 2021. She conducted many training programs under the umbrella of ISoP Middle East Chapter and in collaboration with Arab Health Authorities. She has been invited as a speaker in many conferences both international and regional.

She is passionate about supporting patients, utilizing different channels and tools. Most of her talks about patient engagement, medication adherence and medication errors.

Dr Ghita Benabdallah is a pharmacist, graduated from the Faculty of Pharmacy of the University of Monastir. Monastir, Tunisia.

She started her career in a private pharmacy in Rabat, Morocco for 5 years before joining the Centre Anti Poison et de Pharmacovigilance du Maroc (CAPM), in 2001.

Since 2001: Working in the pharmacovigilance (PV) department, focusing on all PV activities, on promoting patient safety, preventing medication errors, and risk minimization actions.

Since 2006: Involved in various projects in collaboration with the World Health Organization, the World Alliance for Patient Safety, and the Uppsala Monitoring centre (UMC) in Uppsala, Sweden and the Moroccan pharmacovigilance centre to assess the capacity of pharmacovigilance centers to detect and analyze medication errors and to broaden the scope of national pharmacovigilance centers.

She participated with the Moroccan pharmacovigilance team in the development of a new WHO guideline: Reporting and learning systems for medication errors: The role of pharmacovigilance centers.

Since 2011, as the CAPM has been designated a WHO Collaborating Centre for strengthening pharmacovigilance practices, she is involved in trainings in pharmacovigilance and capacity building of health professionals in French-speaking African countries and countries of the Eastern Mediterranean region.

Since 2020, she is involved in pharmacovigilance trainings and capacity building of health professionals to handle the surveillance of covid 19 vaccines.

Dr Ghita Benabdallah is member of international networks for patient safety, medication errors and vaccines.

Dr. Salas is an Executive Medical Director, Global Epidemiology Lead, and Therapeutic Area Lead of the Specialty Medicine, Clinical Safety, and Pharmacovigilance Department at Daiichi Sankyo Inc. She has experience in Pharmacoepidemiology, Pharmacovigilance, Pharmacoeconomics, Clinical Epidemiology, and Outcomes Research.

Dr. Salas is a medical doctor with a specialty in Internal Medicine, and an epidemiologist with more than 20 years of experience in pharmacovigilance and pharmacoepidemiology. Dr. Salas holds degrees in Medicine, Internal Medicine, Outcomes Research, Epidemiology, Clinical Epidemiology, and Pharmacoepidemiology. Dr. Salas is the current president of the North American Society of Pharmacovigilance, and an Adjunct Scholar at the University of Pennsylvania and Rutgers University. Dr. Salas had worked in the Internal Medicine Department, Hospital of Specialties, and Preventive Medicine Department at the University of Alabama at Birmingham (UAB). She was a full-tenure professor at the School of Public Health (SOPH), UAB. At the SOPH, Dr. Salas developed the Pharmacoepidemiology program and represented the Birmingham Center for Education, Research, and Therapeutics (CERTs) at the CERTs National Educational Consortium from the U.S. Human and Health Services Department.

Dr. Salas has worked with multiple large databases such as the Veterans Administration Database, National Medicare and Local Medicaid Databases, Saskatchewan database, Rotterdam database, and others. Dr. Salas has experience working in the pharmaceutical industry, initially, she joined the Patient Safety Departments at AstraZeneca Pharmaceuticals followed by Pfizer Inc, Merck Research Laboratories, and lately Daiichi Sankyo Incorporated, where she is responsible for the development of the Global Pharmacoepidemiology Department, CSPV. Dr. Salas obtained various federal grants, worked with multiple large databases “big data” and “real-world data”, published multiple scientific articles in peer-reviewed journals, and has more than 1000 citations in the scientific literature.

Francesco Salvo is 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.

The founder and the director of the Iraqi Pharmacovigilance Center, hold a PhD in clinical pharmacy. She has over 20 years of experience in medicine regulation, and clinical pharmacy. She has more than 8 years of experience working in pharmacovigilance; managing all work-related details; planning, implementing, following up, improving pharmacovigilance activities, managing communications and staff. In fact, she laid the foundation for the establishment and the expansion of the pharmacovigilance system and pharmacovigilance regulation in Iraq. She represent Iraq in the WHO international drug monitoring program (PIDM).

She has served on many national, regional, and international committees; as a member of the National Biological Registration Committee; an elected ISoP Advisory Board member for 2019–2022 and 2022–2025; representing ISoP in the CIOMS Executive Committee and was a member of the CIOMS WG XI to deliver the “The Patient Involvement in the Development, Regulation, and Safe Use of Medicines guideline; ’Co-chair of the ISoP Patient Engagement Special Interest Group;; Vice-president of the ISoP Middle East chapter. She is a member of the Regional Board of the Antimicrobial Resistance Specialty Committee of the International Academy of Public Health (IAPH). She is also a WHO Bench Marking assessor. She has authored more than 30 articles on different drug safety-related subjects. She is an active trainer and presenter on different aspects related to pharmacovigilance, regulation, and drug safety. She has been an ISoP Fellow since 2021.

Professor Zhang worked in the field of pharmacovigilance and risk management for 15 years at National Medical Product Administration (NMPA). She now works as a physician of Integrated Medicine and is engaged in drug clinical trials and post-marketing research at the Second Medical College（Dongfang Hospital, Beijing University of Chinese Medicine). She has been involved in drug clinical evaluation and safety monitoring for over two decades.

Li is a member of the ISoP Scientific Board, an elected ISoP Advisory Board member (2019-2025), and an Expert of the WHO Uppsala Monitoring Centre signal review panel; Expert of clinical trial inspector of the Center for Food and Drug Inspection of NMPA; Secretary General of Pharmacovigilance Research Committee and Committee member of International Exchange Committee, China Society of for Drug Regulation; Vice Chairman of Data Safety and Monitoring Board of World Federation of Chinese Medicine Societies; Vice Chairman of Traditional Chinese Medicine Working Committee and Board member of Diabetes Committee, Beijing Association of Chinese Medicine; member of International Society of Pharmacoepidemiology. She is an editorial board member of Drug Safety, Chinese Journal of Pharmacoepidemiology and Drug Evaluation Research. She is also a reviewer for Pharmacoepidemiology and Drug Safety, European Journal of Integrative Medicine, Chinese Journal of Hospital Pharmacy, and Chinese Journal of New Drugs.

She has published more than 90 articles in peer-reviewed national and international scientific journals, while compiled or participated compiled 28 books, monographs and chapters as chief editor, and associate editor.

Dr Mira Harrison-Woolrych is the immediate past President of ISoP and Chair of the ISoP Women’s Medicines Special Interest Group. She is a Fellow of the Royal College of Obstetricians and Gynaecologists and worked in clinical positions in England and New Zealand before undertaking medical research in women’s health. During her career in pharmacovigilance, Mira has worked in medicines regulation at MHRA in London and was the previous Director of the New Zealand Intensive Medicines Monitoring Programme (IMMP), which conducted active post-marketing surveillance and pharmacoepidemiology research until 2013.

Mira is the author of over 70 academic papers; two pharmacovigilance textbooks (Medicines for Women and An Introduction to Pharmacovigilance) and two books of fictional short stories (Admissions and New Admissions). Mira still lives and works in Aotearoa New Zealand, in the Department of Women’s and Children’s Health at Otago University. She also works as a writer and is a long-standing member of a national ethics committee.