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).

Florah is a pharmacist by profession currently heading the pharmacovigilance unit of South African Health Products Regulatory Authority (SAHPRA). She holds BPharm and master’s in pharmacy with specialisation in Pharmacovigilance & Pharmacoepidemiology. She joined SAHPRA in 2011 as Medicine Registration Officer in the Pharmaceutical & Analytical Directorate and later Head the Vigilance unit since October 2015 to date. She has experience in different pharmacy sectors, including medicines regulation, retail and hospital pharmacy. She has attended different pharmacovigilance courses offered internationally including training by Uppsala Monitoring Centre.

She supports the National Immunisation Safety Expert Committee and member of African Union Smart Safety Surveillance (AU-3S) Joint Signal Management Group, aimed at facilitating cross-country signal management for COVID-19 vaccines in Africa, to support action in the interest of public health and safety.

Max Goldberg leads the global medical device reporting team for Worldwide Patient Safety at BMS. He holds a bachelors and master’s degree in engineering and has expertise in medical devices and combination products throughout the entire product lifecycle. Max has been involved in product development, risk management, manufacturing, and post market surveillance for medical devices, combination products, and biologics. He is involved in forming and implementing global combination product post market safety reporting regulation.

She is an American board certified for pharmacotherapy specialty, she has two master degrees, one in clinical. pharmacotherapy and the second in public Administration from the American University in Cairo.

She is a fellow at the Egyptian board for healthcare management. She has profound working history in regulating pharmaceutical practices in the Egyptian public and private sectors, she used to be managing the PV General administration for more than 2 years, supporting the additionally, she represents the Egyptian drug authority as an Observer at the international cooperation on cosmetic regulations working group ICCR. Previously, she used to be the antimicrobial stewardship national coordinator and participated in the development of the National Action Plan for Antimicrobial Resistance.

She is a pharmacist by training. She has specialized in Pharmacoepidemiology and Pharmacovigilance, currently enrolled for PHD studies in Clinical Pharmacology and Pharmacovigilance at Karolinska Institutet in Sweden focusing on strengthening safety monitoring in public health programs with a focus on mass drug administration.

She is the Head of Pharmacovigilance at the Pharmacy and Poisons Board, Kenya, and the Vice President of International Society of Pharmacovigilance, Africa Chapter. She has 15 years working experience in Pharmacovigilance related work and is responsible for leading the PV team in Kenya to develop regulatory systems to strength Pharmacovigilance within the health sector and pharmaceutical industry.

She is a member of the Pharmacovigilance and PMS technical working groups in Kenya, within the East African Community and The Intergovernmental Authority on Development Regional Economic Blocks and has contributed to development of various tools and guidelines for strengthening of PV in the region. Recently appointed as a member of the AMRH Technical Committee on Regulatory Capacity Development in Africa (ToR RCD)

She is passionate about patient safety and keen on strengthening pharmacovigilance systems and patients’ contribution to safety monitoring of medical products and health technologies, she is also keen in contributing to a pool of trained PV specialists in Kenya and gives honorary lecturers to both undergraduate and masters students at University of Nairobi.

Pr Nadjat LOUMI-MEDEDJEL, Director of the Centre National de Pharmacovigilance et de Materiovigilance (CNPM), is a doctor graduated from the University of Algiers, holding a Diploma of Advanced Studies from the Faculty of Medicine of Paris (France), a university degree in pharmacovigilance from the university Claude Bernard of Lyon and a doctoral thesis in clinical pharmacology at the Faculty of Medicine of Besançon (France).

She took part in the creation of the CNPM with its founder Professor A Helali in 1998, whereshe has always been devoted to pharmacovigilance and materiovigilance.

Since 2016, she has introduced the concept of Phytovigilance, Réactovigilance, Cosmetovigilance, in addition to the vigilance of the drug, the medicaldevice and the vaccine alreadyestablished.

Teacherat the Faculty of Medicine of Algiers, wheresheteaches the module of pharmacology. She supervises the training of resident physicians in clinical pharmacology.

She supervises also the training of health professional in :

“Pharmacovigilance and Materiovigilance” ; “Medical good prescribing” ; “Monitoring plasmatic of medicine” ; “Rational drug use program”.

She is Editor of the independent Medical journal “la Revue Prescrire” since 2007.

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.

Brève présentation : Pharmacien, marié et père de trois enfants. J’ai treize (15) ans d’expérience professionnelle dont dix (10) ans dans le domaine de la réglementation et de la régulation pharmaceutique. Je suis dans l’amélioration continue du travail et j’ai une bonne capacité d’adaptation. Mes objectifs professionnels : Acquerir une excellente compétence dans la régulation pharmaceutique et Partager ces connaissances acquises en tant qu’expert.

Dr. Amira Amin received her Bachelor degree of pharmaceutical science. faculty of pharmacy, Cairo University in 2006 and Diploma in clinical pharmacy from faculty of pharmacy (Ain-Shams university) in 2010.

Today she is the deputy head of Egyptian pharmaceutical vigilance administration at Egyptian Drug Authority since September 2020 and joined from pharmacovigilance specialist at Egyptian pharmacovigilance center (EPVC) – (CAPA) – Ministry of health (MOH) where she honed her skills for 6 years.

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).

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.

MRS HOUDA SEFIANI is medical doctor, graduated from Rabat University School of medicine, Morocco. Specialized in pharmaco-toxicology. She has a PHD in Health Vigilances field.

She began her career as practitioner during 4 years before integrating the WHO Collaborating Centre: Moroccan Poison Control Centre and Pharmacovigilance Centre, in 2007.

Since 2007: working in pharmacovigilance activities, focusing on cases analysis, causality assessment, signal detection and risk minimization actions.

Since 2008: Involved in different training and pharmacovigilance development projects in collaboration with the World Health Organization, Monitoring Medicines Project, Uppsala Monitoring Centre and the Moroccan Pharmacovigilance Centre, to promote Pv in Africa and MENA region and to develop new tools to manage ADRs.

Since 2014, She is member of ATC-DDD WHO Working group.

Lebogang has over 12 years of working experience in the Pharmaceutical Industry, a fully registered Pharmacist with the Botswana Health Professions Council graduated with a Bachelor of Pharmacy from the Latrobe University, Bendigo Australia.

A Pharmacovigilance Manager with the Botswana Medicines Regulatory Authority (BoMRA), Lebogang has a firm grip in the Drug Regulatory systems, Market dynamics and pharmaceutical industry, currently responsible for core PV operational functions including Case Management, and Quality and Document Management, managing the operation infrastructure required to oversee all aspects of adverse event collection, processing, and reporting from clinical trials.

As the Immediate Past President of The Pharmaceutical Society of Botswana, Lebogang is involved in the development of Campaigns that promote health care industry and has gone to develop strategic relations and collaborations with stakeholders within the health industry in Botswana and the SADC region. A member of the Commonwealth Pharmacist Association Council, his role includes but not limited to advocating for collaboration and partnership amongst the Commonwealth Pharmacy Associations. A member of the joint taskforce for the Ministry of Health & Wellness and Business Botswana mandated with developing strategic projects that will see private sector collaboration in public healthcare delivery. Also, member of International Society of Pharmacovigilance

LK as he is affectionally known prides himself with the development of safety exchange agreements with license partners and distributors in support of PV collaborations, a firm believer that accomplishments validate facts you already know while setbacks teach the hard lessons.

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.

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).

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.

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).

Professor Riadh DAGHFOUS is a Doctor of Medicine MD. He received the title of Physician Resident for Hospitals of Paris in 1990 and obtained his specialty in Pharmacology at the University of Tunis during the same year. He became an Assistant lecturer in Pharmacology at the Faculty of Medicine of Tunis in November 1991 and Associate Lecturer in December 1996 and now he is a professor of pharmacology since December 2004.

He has held several teaching positions including the position of coordinator of Pharmacology teaching (from 2002 to 2008) in the Faculty of Medicine of Tunis.

At the national level, he is now the Head (General Director) of the Tunisian National Center of Pharmacovigilance since January 2017and, the head of Covid-19 scientific vaccination committee and member of the Tunisian Health Ministry COVID-19 scientific committee, since 2021.

Professor Riadh DAGHFOUS is a member of the Clinical Pharmacology Research Laboratory of the National Center for Pharmacovigilance and of the Pharmacology Research Unit at the Faculty of Medicine of Tunis and is also a national expert in clinical trials since 1999. He’s an author of numerous national and international publications.

At the international level, he occupies the position of Tunisia representing in the WHO for the international network for the surveillance of pre-qualified vaccines.

He has been a founding member of the African society of pharmacovigilance since 2012 and a member of the International Society of Pharmacovigilance since 2001.

is a Pharmacovigilance (PAVIA) coordinator in Eswatini. Alemayehu is a pharmacy professional with advanced skills around pharmaceutical services and pharmacovigilance (Patient safety). He has over ten years of proven experience in pharmaceutical services, academia and pharmacovigilance at national, regional and facility levels.

In his current role as a Pharmacovigilance Africa (PAVIA) coordinator with Eswatini National Pharmacovigilance center, he coordinates pharmacovigilance activities and provide technical assistance to the National pharmacovigilance center in the Government of the Kingdom of Eswatini to strengthen the pharmacovigilance system.

He previously worked with various USAID-funded projects including Management Science for Health (MSH)/SIAPS project as a Technical Advisor-patient safety as well as in Universities in Eswatini as a Lecturer.

Alemayehu holds a bachelor’s degree in Pharmacy, a master’s degree in clinical research and currently pursuing his Ph.D. in pharmacovigilance and pharmacoepidemiology at the University of Bordeaux, France through EU2P program. He has also done various PV training with different institutions.

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.

PV Hub partner in Dubai Pharmacovigilance (PV) Hub with over 8 years of experience in Pharmacovigilance. Currently the Hubs Submissions champion and Automation Champion.

Career: Medical representative (Roche Nigeria); Medical tourism (Dubai UAE), Pharmacovigilance and drug safety (Roche Dubai, UAE)

Driving process improvement to achieve efficiency and better ways of working is my ethos.

She is responsible for the implementation and maintenance of an effective local pharmacovigilance system for the respective affiliates, the development and implementation of the local Patient Safety strategy, ensuring active contribution, partnership with local and global stakeholders.

She is a Medical Doctor graduated from Faculté de Médecine de Tunis. She joined Roche in 2012 as Clinical Trials Manager with full accountability for all the assigned studies at country level.

She worked in different positions with increasing responsibilities in Clinical Research in diverse therapeutic areas, Safety, Quality management and Medical Affairs for Tunisia and Libya. She has a strong passion to create value and sustainable impact on the ecosystem.

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.

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 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

Comfort Ogar is a global safety consultant with the WHO on the novel oral polio type 2 vaccine (nOPV2). Prior to her work with the WHO, she was a Principal Technical Advisor and pharmacovigilance lead for the USAID funded Medicines, Technologies, and Pharmaceutical Services (MTaPS) program led by Management Sciences for Health, where she supported low- and middle-income countries in Africa and Asia to establish or strengthen their regulatory systems with particular focus on pharmacovigilance systems. She worked as a regulator for about 18 years at Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), where she was instrumental to establishing the country’s national pharmacovigilance system.

She has a master’s in public health (MPH) from The Hebrew University of Jerusalem, and a master’s in medical sciences (MMSc) in Global Health Delivery from the Harvard Medical School and is a PhD candidate at the University of Utrecht. Comfort is the current secretary of the Africa chapter of the International Society of Pharmacovigilance (ISoP). She is married with two children. She loves traveling and mountain biking.

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.

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.

An Egyptian Pharmacist with 6-year- experience in PV working in different companies ensuring the patients’ safety in various regions (Egypt, Gulf and Levant).

Currently, the LSR back-up in Roche Egypt for the past 4 years and the former LSR in Roche Gulf for 2.4 years.

Before joining Roche, Nour has worked in Bayer PV department covering the Middle East.

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.