DR. SHAHINAZ BADR

/in /by

Shahinaz, pharmacist with more than 20 years’ experience in pharmacy and pharmaceutical business, currently working as Pharmacovigilance Quality auditor for companies in the EMEA region.

Started her career as a clinical pharmacist in Cairo University Medical School Teaching Hospital integrating with top HCPs of different specialties in interdisciplinary healthcare systems, where safety monitoring was always an integral part of clinical practice. Leveraging on her expertise, she joined the pharmaceutical industry working in Regulatory Affairs and later regional positions before focusing on Pharmacovigilance.

Actively working in pharmacovigilance regulatory Intelligence in a role enabling her to interact with industry colleagues and Competent Authority Pharmacovigilance departments. Shahinaz has contributed to several international initiatives and partnerships to help support patient safety and improve the monitoring of drugs for safety.  She is an active member the ISOP Special Interest Group collaborating in the initiation of the GPPC (Global Pharmacovigilance Certificate).

DR. VIVIAN RAKUOMI

/in /by

Vivian Rakuomi is a Pharmacovigilance and Health system strengthening pharmacist with over 14 years of experience working in both public and private sector of health care in sub-Saharan Africa and Asia. Currently he is a Senior Technical Advisor-Regulatory System Strengthening, with the MTaPS program within the Management Sciences for Health (MSH). He has provided technical oversight in the implementation of health and pharmaceutical projects in EAC and partner states, IGAD and its member states, as well as within Kenya and in Asia working with the regional bodies.

His areas of expertise include health systems management and strengthening; pharmaceutical services and systems strengthening; regional multi-country regulatory harmonization processes; pharmacovigilance and medication safety; medicines and therapeutics committees and rational use of medicines; quality healthcare and patient safety; standards-based pharmaceutical management (accreditation of pharmaceutical services), project management and capacity building; developing funding proposals, technical strategies, workplans and budgets among others.

He has worked with the Ministry of Health, Kenya, as a senior deputy pharmaceutical specialist offering services at policy and patient level, and the National Medicines Regulatory Authority in Kenya (The Pharmacy and Poisons Board) as a regulatory officer for pharmacovigilance and head of the post marketing surveillance (PMS) division. He is a Bachelor of Pharmacy graduate with a Master of Pharmacy in Pharmacoepidemiology and Pharmacovigilance.

DR. SISAY ENDALE BIRU (B.Pharm,BA MSC.)

/in /by

Sisay Endale Biru is an academician and researcher at Addis Ababa University, College of Health Sciences, School of Pharmacy, Ethiopia. He completed his Bachelor of Pharmacy from Addis Ababa University and Master of Sciences in Regulatory Affairs (Medicine Regulation Track) from the same university.

 

He also graduated from Admas University with a bachelor’s degree in Marketing Management. He is currently engaged in research, teaching, and advising. He is the coordinator of Pharmacovigilance (PV) at the Tikur Anbessa Specialized Hospital’s PV center in Addis Ababa, Ethiopia. He works with the Ethiopian Pharmaceutical Association as a trainer, PV course lead, and CPD course evaluator.

 

Additionally, he actively contributes to the development of policy, research, the development of PV training materials, and the assessment of medication dossiers for the Ethiopian Food and Drug Authority (EFDA). His research interests include health and drug policy analysis, drug regulation, and drug safety (PV).

Dr. MANAL M. YOUNUS

/in /by

Dr Manal Younus is currently the head of Iraqi Pharmacovigilance Center based in MOH. Manal is a pharmacist with a Ph.D. in Clinical Pharmacy. Key achievements include the establishment and the expansion of the Iraqi pharmacovigilance system. Represent Iraq in the WHO international drug monitoring program (PIDM). She is an International Society of Pharmacovigilance (ISoP) Advisory Board member  and represent ISoP in the Council of International Organizations of Medical Sciences (CIOMS). Manal is the vice president of the ISoP Middle East chapter,  ISoP Pharmacovigilance Professional Qualification Framework SIG member and she had authored more than 30 articles in different drug safety related subjects. Finally, a member of the specialized committee for Antimicrobial Resistance of the International Academy of Public Health (IAPH).

MR. GEORGE SABBLAH

/in /by

George is a pharmacist by profession and had a Master degree in Public Health from the University of Ghana and a certificate in Pharmacovigilance and Pharmacoepidemiology from London School of Hygiene and Tropical Medicine. He is currently a PhD candidate at the University of Groningen where his thesis is focused on patients’ contribution to pharmacovigilance in Sub-Saharan Africa.

He is a Chief Regulatory Officer and the Head of the Safety Monitoring Department at the Food and Drugs Authority.

He has authored several abstracts and original research articles on medicine safety in peer reviewed journals.

 

George’s interest is in strengthening pharmacovigilance systems and patients’ contribution to safety monitoring of medicines and other health products.

MR. SEÁN BURKE

/in /by

18 years working in pharmacovigilance, of which 10 have been as a director of pharmacovigilance for the affiliates at MSD. In his current role, Sean provides pharmacovigilance support to primarily the Eastern Europe, Middle East and Africa regions.

Mr. Sean supports in the development of local PSMF’s at MSD, which are legislatively required or requested pre-inspection.

Responsible for Pharmacovigilance activities in the EU and Balkans, as well as PV Intelligence and Operational activities within the International PV organization.

Sean is a chairperson of two EFPIA PV working groups, (Africa and the Middle East).

MS. ANASTACIA NAIDOO

/in /by

Anastacia Naidoo holds a MSc Pharmacotherapy degree and is employed at MSD South Africa as the Pharmacovigilance Country Lead for South Africa and Sub-Saharan Africa.

 

In her role at MSD, Anastacia is responsible for all local PV activities related to the 27 African countries under her responsibility.  Anastacia has over a decade of PV experience and has also worked at the two largest South African Pharmaceutical companies in South Africa, Aspen Pharmacare and Adcock Ingram.

MR. LAZARE NTIRENGANYA

/in /by

He is the Division Manager for Pharmacovigilance and safety monitoring division at Rwanda Food and Drugs Authority (Rwanda FDA). He is a holder of bachelor’s degree in pharmacy from National University of Rwanda and master’s degree in Public Health Methodology from Université Libre de Bruxelles/Belgium. Currently, he Heads a division at Rwanda FDA that includes different regulatory functions mainly Pharmacovigilance, clinical trial oversight, Post marketing surveillance, promotion, and advertisement con trol.

He held different position in Health system in Rwanda including Deputy director of District Pharmacy and Chief Pharmacist at Bushenge Provincial Hospital for 5 years where he was focusing and dedicated in clinical Pharmacy practice, Quality Improvement, and supply chain management. He was involved in Pharmacovigilance harmonization process in East African Community. He was involved in establishment of different regulatory function at Rwanda FDA where He coordinated development of different regulations and guidelines especially these governing Pharmacovigilance, conduct of clinical trials, Post marketing surveillance, promotion, and advertisement of regulated products in Rwanda. He was involved in development of Hospital accreditation standards in Rwanda. He has different trainings especially trainings in pharmacovigilance, clinical trials, Translation medicines, Pharmacometrics, Assessment and registration of medical products.

MS. HELA BEN SOLTANA

/in /by

She is a pharmacist, that graduated from University of Pharmacy in Tunisia and also holds a master’s degree in marketing Intelligence and Strategic Monitoring.

 

Prior to joining Bausch and Lomb, she worked for several companies in pharmacovigilance and regulatory affairs sectors (AbbVie, Novo Nordisk, and Sanofi Pasteur).

 

Ms. Hela also has regulatory experience with Novo Nordisk and Sanofi Pasteur for Tunisia and Libya.

 

MR. JEAN-CHRISTOPHE DELUMEAU MD, PhD, FISoP,

/in /by

Jean-Christophe Delumeau, a member of the Scientific Board of the International Society of Pharmacovigilance (ISoP), graduated in medicine and neuropharmacology from universities of Rennes and Sorbonne (Paris).

After medical residency, he completed a research program in intracellular signalling at the National Institute of Medical Research (Inserm, France), then moved to clinical research in healthcare companies based in Basel, Paris, and Tokyo where he conducted multinational trials in neurodegenerative diseases and cerebrovascular disorders.

From 2001 until June 2020, he exerted the responsibilities of regional pharmacovigilance leader at Bayer in Japan, China, and Singapore until his appointment as head of pharmacovigilance policy strategy with a global scope. On July 1st, 2022, Jean-Christophe Delumeau, was appointed as a board director of the Institute of Pharmacovigilance, the NGO developing the Global Pharmacovigilance Professional Certification in collaboration with ISoP.