SEÁN BURKE

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

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.

LAZARE NTIRENGANYA

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.

HELA BEN SOLTANA

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.

 

JEAN-CHRISTOPHE DELUMEAU MD, PhD, FISoP,

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.

DR. NDINDA KUSU

Dr Ndinda Kusu is the Country Project Director with the USAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program and the team lead for Management Sciences for Health in Kenya. She is a clinical pharmacist and an experienced public health, program management and health system strengthening specialist with over 25 years of experience working with public, private, and faith-based health sectors strengthening health and pharmaceutical systems to increase access to and use of medicines and health technologies.

 

She has done immense work in governance, human and institutional capacity development; development and implementation of policies, guidelines, curricula, and tools; implementing continuous professional development; supporting continuous quality improvement, promoting rational use; curbing antimicrobial resistance and strengthening regulatory systems.

 

She has a passion for promoting patient safety through pharmaceutical care, infection prevention control (IPC) and pharmacovigilance systems strengthening. Ndinda has spearheaded premier initiatives such as the introduction of the Kenya Pharmacovigilance Electronic Reporting System, curricula reform, and introduction of a postgraduate Masters’ course on Pharmacoepidemiology and Pharmacovigilance at the University of Nairobi.

 

In support of African Medicines Regulatory Harmonization (AMRH) agenda, Ndinda worked with the East African Community (EAC) Secretariat, Intergovernmental Authority on Development (IGAD) and other AMRH partners to support the EAC and IGAD Medicines Regulatory Harmonization Initiative through the development and implementation of harmonized regional guidelines, tools and approaches. She is a member of several health professional associations and committees.

Ndinda holds a Bachelor’s degree in Pharmacy and Masters’ degrees in Clinical Pharmacy and Public Health

HADIR ROSTOM

WHO consultant, Scientific board member at the International Society of Pharmacovigilance (ISoP), President of ISoP Egypt Chapter. Co-founder and former head of the Egyptian Pharmacovigilance Center, Pharmacovigilance Lecturer at MSA University. She was a principal contributor in issuing the “Good Pharmacovigilance Practice guidelines in Arab Countries” (GVP-Arab). At that time, she introduced new regulatory concepts to boost the PV practice at affiliate level for international pharmaceutical companies (e.g. Pharmacovigilance sub-system file “PSSF” & national display of a RMP). And established the national Pharmacovigilance Inspection program. She played an important role in strengthening Pharmacovigilance practice in Egypt and integrating pharmacovigilance teaching in Academia. She participates in numerous pharmacovigilance & medication safety training at the national and international levels. She supervised several pharmacovigilance research projects and had a list of publications in medication safety.

Mr. LIBERT CHIRINDA

Libert Chirinda is a Chief Regulatory Officer in the Pharmacovigilance and Clinical Trials (PVCT) Division at the Medicines Control Authority of Zimbabwe (MCAZ), where he is involved in managing vigilance activities as well as clinical trials oversight activities.

He has more than eight years’ experience in pharmacovigilance activities and regulatory affairs, and has been part of the PVCT Division, which is also the National Pharmacovigilance Centre for Zimbabwe, since 2013. He has been involved in several pharmacovigilance initiatives locally, regionally, and internationally, and seeks to improve pharmacovigilance systems in Zimbabwe and beyond.

He holds a Bachelor of Pharmacy Degree from the University of Zimbabwe (UZ), as well as a Master of Health Sciences Degree in Pharmacovigilance from the University of KwaZulu-Natal (UKZN).

Outside the work environment, Libert can usually be found playing chess or reading. Libert has been an avid reader for as long as he can remember, and his choice of literature spans across genres.

DR. ZAKARIA THAMRI

Zakaria holds a Doctoral degree in pharmacy from Algeria and a Pharmacovigilance certificate from France,

 

He started his career in Pharmacovigilance at Roche Pharmaceutical, where he has also served in different roles in Medical Affairs and Products quality.

 

Zakaria joined Boehringer Ingelheim in February 2019 as Local Pharmacovigilance Manager for North-West Africa Region and is currently, Regional Pharmacovigilance Lead for IMETA region (India, Middle East, Turkey and Africa) based in Dubai-UAE.

MS. ANNA M. SHIMBULU

Anna is medicines information and safety pharmacist with a Master’s of Science in Clinical Pharmacology. She has been heading the national pharmacovigilance centre for over 6 years. Prior to joining the regulatory authority in 2015, she worked in hospital pharmacy where she was also the focal person for pharmacovigilance.

She is the national focal person in the ongoing EDCTP funded project (April 2020 – March 2023) aimed at Strengthening Pharmacovigilance and Regulatory Capacities in four Southern African countries (SPaRCS).

Anna serves as a member of the Namibia Essential Medicine List committee as well as the Education Committee of the Pharmacy Council of Namibia.