Dr Brian Edwards
(Chair of the Scientific Committee)
Managing Director of Husoteria Ltd
Vice President of The ISoP
Dr Edwards trained as a medical doctor 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 13 years up until 2021, he was Principal Consultant in Pharmacovigilance at NDA Regulatory Science based in the UK. In addition, he 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 was 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 Benefit Risk Assessment Planning working group since 2020. He was elected back to the Executive Committee of ISOP in 2022 and is Vice-President of ISoP and Director of ISOP Secretariat Ltd. In May 2023 he was awarded a Global Fellowship in Medicines Development.
Hadir Rostom
Pharmacovigilance consultant,
Lecturer at MSA University
Pharmacovigilance consultant, Lecturer at MSA University, member of the WHO Advisory Committee on Safety of Medicinal Products (WHO-ACSoMP), Lead Senior PV auditor, President of Egypt Chapter of ISoP, Member in ISoP Scientific Board.
She has 24 years experience in the Pharmaceutical sector, including 14 years extensively in pharmacovigilance domain. She is Co-founder and former head 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, supervised several PV research projects and has a list of publications in the pharmacovigilance and drug safety. 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.
Mayada Alkhakany
CEO - Baghdad Heart & National Health Factory
Dr. Mayada Alkhakany is a visionary leader in the healthcare and pharmaceutical industries. As CEO of Baghdad Heart and National Health Factory in Iraq, she is committed to healthcare innovation and improving patient care on national and global levels. She is also the founder of a healthcare consultancy focused on empowering patients and building sector capabilities. In her previous role as Regional Market Access, Healthcare Affairs, Innovation, and Patient Engagement Leader at Boehringer Ingelheim UAE, Dr. Alkhakany spearheaded impactful initiatives for patients and stakeholders across the region. She has held key positions at Boehringer Ingelheim, including Global Senior Non-Trial Activities Manager, and Head of Pharmacovigilance for the Middle East, Turkey, and Africa. Prior to Boehringer, she held pivotal roles at Merck Sharp & Dohme (MSD). Dr. Alkhakany is an Advisory Board Member of the International Society of Pharmacovigilance (ISoP) for 2023-2026 and the founder and chair of its Patient Engagement Group. She is also a co founder of the ISoP Middle East Chapter. Additionally, she contributes to ISPOR (International Society for Pharmacoeconomics and Outcomes Research), focusing on patient engagement and digital healthcare solutions. A lifelong learner, Dr. Alkhakany holds a dentistry degree from Baghdad University and has completed prestigious international programs at institutions such as IESE Business School and Harvard University. She is renowned for her leadership, innovation, and advocacy in patient safety and engagement, shaping the future of healthcare globally.
Mohamed A. Elhawary
Vaccine Safety Officer & General Secretary of ISoP Egypt Chapter
Ministry of Health & Population (MoHP)
Mohamed is an expert in medication and vaccine safety with extensive experience in pharmacovigilance and regulatory affairs. He previously served as a Medication Safety Officer at the International Committee of the Red Cross (ICRC), where he focused on promoting the safety monitoring of medicinal products in resource-limited settings. Mohamed also worked as a Pharmacovigilance Coordinator & Instructor at the Central Administration of Pharmaceutical Affairs at Egypt's Ministry of Health & Population (MoHP), contributing to the enhancement of the country’s pharmacovigilance systems and he training of key personnel. Currently, Mohamed is a Vaccine Safety Officer with the Expanded Program of Immunization (EPI), where he ensures the safety and effectiveness of immunization programs. He has developed protocols, standard operating procedures (SOPs), and reports, and has presented scientific and regulatory data at both departmental and national meetings. In addition to his professional roles, Mohamed serves as the General Secretary of the ISoP Egypt Chapter, further supporting the growth and development of the pharmacovigilance in Egypt. He has also authored multiple publications in respected scientific journals, contributing to advancements in the field of medication and vaccine safety in Egypt.
Jimmy Jose
Associate Professor (Pharmacy Practice)
University of Nizwa
Dr. Jimmy Jose is an Associate Professor in Pharmacy Practice/Clinical Pharmacy, and College Consultancy and Collaborative Activities Officer at the University of Nizwa, Sultanate of Oman. His previous major academic appointments include in International Medical University, Malaysia. He is the lead editor of a recently published textbook by Springer Nature in the field of pharmacovigilance, ‘Principles and Practice of Pharmacovigilance and Drug Safety’; a book written from the perspective of a practitioner, industry personnel, researcher, or regulator, creating a synergy between drug safety, pharmacovigilance, and clinical practice. Dr. Jose was awarded his PhD in the field of pharmacovigilance. He was trained in clinical pharmacy at Michigan hospitals, USA, and has international clinical pharmacy experience in both Oman and India. His primary field of research is hospital-based pharmacovigilance and has special interest in studying the knowledge, practice, and role of patients/public in drug safety. He has published multiple book chapters on pharmacovigilance and several articles on drug safety/pharmacovigilance in peer reviewed journals. He has contributed extensively to the training of the health care professionals on medication safety with the national pharmacovigilance team in Oman and he is the country representative- Oman for International Society of Pharmacovigilance- Middle East Chapter. He has held position as ‘Consultant’ for pharmacovigilance organisations in the industry. He serves as an Associate Editor for the journal Pharmacoepidemiology and Drug Safety and as an Editorial/Advisory Board Member for various other journals. He has led internally and externally funded multidisciplinary research projects in the field of drug safety.
Dr Viola Macolic Sarinic
PRAC Scientific Committee Lead and Adviser on Safety of Medicines
European Medicines Agency (EMA)
Dr Viola Macolic Sarinic is a medical doctor and clinical pharmacologist with a PhD in pharmacogenomics applied to biosciences and a master’s in clinical pharmacology. With over 20 years of experience in clinical pharmacology, regulatory affairs, and pharmacovigilance, she has worked in academic, clinical and regulatory environments. Viola’s career includes key roles as a clinician, clinical and pharmacovigilance assessor, head of the national Agency’s pharmacovigilance department, and member of the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Human Medicines Products (CHMP) at the European Medicines Agency (EMA). She also served as the director of the Croatian Medicines Agency (HALMED) for four years. Viola has international experience, having worked at the EMA in London in the scientific advice office and at the WHO headquarters in Geneva in the Pharmacovigilance team. There, she contributed to strengthening pharmacovigilance systems in low- and middle-income countries (LMICs). Currently, Viola is the Pharmacovigilance risk assessment committee’s (PRAC) Scientific Lead at the EMA in Amsterdam, where she continues to shape pharmacovigilance activities and contribute to the safety of medicines in the European Union and beyond.
Santiago Schiaffino
Senior Director, Patient Safety Biopharma AstraZeneca
A highly accomplished Medical Doctor, graduated with Honors from Buenos Aires University in 2002, specializing in paediatrics and clinical pharmacology, with advanced training in pharmacovigilance. He earned a sub-specialization degree in Pharmacovigilance from Argentina's Health Authority and further enhanced his expertise by completing a Master’s in Safety of Medicines at the University of Seville, Spain. With more than 15 years of experience in the pharmaceutical industry, he has held several pivotal roles in pharmacovigilance, gradually transitioning through a variety of responsibilities that have allowed him to develop an indepth understanding of the field. Since 2020, he has been an active member of the International Society of Pharmacovigilance (ISoP), participating in the prestigious ISoP Fellowship program, which is designed for professionals in the field to collaborate and advance safety initiatives globally. Currently, he serves as Senior Director of Global Patient Safety Biopharma at AstraZeneca, where he leads strategic initiatives to ensure the safety of patients through the effective management and oversight of pharmacovigilance processes. His career reflects a dedication to patient safety and pharmaceutical sciences, underscoring his role as a trusted leader and expert in the ever-evolving world of pharmacovigilance and drug safety.
Eugene van Puijenbroek
Clinical Pharmacologist
The Netherlands Pharmacovigilance Centre Lareb
Eugène van Puijenbroek is a medical doctor and clinical pharmacologist who has been working at the Netherlands Pharmacovigilance Centre Lareb since 1994. From April 2014 till April 2024 he was professor of pharmacovigilance at the Faculty of Science and Engineering, Department of PharmacoTherapy, -Epidemiology and -Economics of the University of Groningen, the Netherlands. He obtained a vast experience analysing signals in the spontaneous reporting system of the Netherlands and published in national as well as international journals. Next to his work in pharmacovigilance he has been working as a general practitioner from 1991 till 2006. His current field of attention is the development of signal detection methodologies, especially the integration of the statistical approach combined with the use of clinical information. He was a member of the Executive Board of the International Society of Pharmacovigilance from 2006 till 2012 and is currently member of the ISoP Scientific Board. He was co-opted member of the Pharmacovigilance Working Party of the European Medicines Agency from 2010 till 2012. He is a member of the editorial board of Drug Safety since 2001 and Chair of the Signal Management Review Technical Working Group Methods Work stream of the European Medicines Agency. Eugène van Puijenbroek has been coordinating national and international studies focussing on the safety of drugs. He coordinated postgraduate training courses on pharmacovigilance and supervises several PhD students working in the field of Drug Safety.
Alem Zekarias
Senior Pharmacovigilance Scientist
Uppsala Monitoring Centre
Alem Zekarias is a highly experienced Senior Pharmacovigilance Scientist within the Research Department at Uppsala onitoring Centre (UMC). With over a decade of experience in global pharmacovigilance (PV), she has worked in diverse areas, such as signal management, research methodology for PV practice, education, and training, among others. Additionally, she has also authored scientific publications in the field of PV. She has been leading and managing several international collaborations, bringing valuable experience in fostering partnerships and coordinating efforts across diverse stakeholders. This role has broadened her global perspective and enhancing her ability to address complex challenges in pharmacovigilance effectively. Also, she has served as a project manager for the Special Interest Group (SIG) on medication error. Driven by a strong passion for understanding and addressing the evolving needs and challenges in pharmacovigilance, she strives to develop innovative solutions that deliver meaningful impact. At UMC, she serves as the key lead for medication error-related initiatives, ensuring these critical activities align with international safety standards and organizational objectives. A pharmacist by training, Alem holds a Master’s Degree in Drug Discovery and Development from Uppsala University. Before joining UMC, she gained valuable experience as a pharmacy manager and contributed to clinical trial operations.
Jayesh Pandit
PVCH and QPPV Coordination Lead, East and North-West Africa
Dr. Jimmy Jose is an Associate Professor in Pharmacy Practice/Clinical Pharmacy, and College Consultancy and Collaborative Activities Officer at the University of Nizwa, Sultanate of Oman. His previous major academic appointments include in International Medical University, Malaysia. He is the lead editor of a recently published textbook by Springer Nature in the field of pharmacovigilance, ‘Principles and Practice of Pharmacovigilance and Drug Safety’; a book written from the perspective of a practitioner, industry personnel, researcher, or regulator, creating a synergy between drug safety, pharmacovigilance, and clinical practice. Dr. Jose was awarded his PhD in the field of pharmacovigilance. He was trained in clinical pharmacy at Michigan hospitals, USA, and has international clinical pharmacy experience in both Oman and India. His primary field of research is hospital-based pharmacovigilance and has special interest in studying the knowledge, practice, and role of patients/public in drug safety. He has published multiple book chapters on pharmacovigilance and several articles on drug safety/pharmacovigilance in peer reviewed journals. He has contributed extensively to the training of the health care professionals on medication safety with the national pharmacovigilance team in Oman and he is the country representative- Oman for International Society of Pharmacovigilance- Middle East Chapter. He has held position as ‘Consultant’ for pharmacovigilance organisations in the industry. He serves as an Associate Editor for the journal Pharmacoepidemiology and Drug Safety and as an Editorial/Advisory Board Member for various other journals. He has led internally and externally funded multidisciplinary research projects in the field of drug safety.
