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Pharmacovigilance Protocols in Sub-Saharan Africa: A Round Table Discussion

Date: Wednesday, October 27, 2021, 3.00 to 5.00 pm EAT

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When a drug or vaccine is approved for use, healthcare organizations monitor it regularly to ensure that it is both safe and effective. The potency of this supervision is primarily determined by each nation’s healthcare system and medical practices. A successful strategy for recognizing and reporting any unwelcome medical occurrences after using a pharmaceutical medication is crucial. Adverse product quality, severe drug responses, and medication errors all lead to a high morbidity and mortality rate. This is where pharmacovigilance is essential.

New medicines and vaccines are being specifically developed for usage in Sub-Saharan Africa. However, in many of the target nations, the introduction of new medications is not supported by pharmacovigilance protocols to monitor medicine safety, with information on the safety profile dependent on existing substandard systems.

Hence, pharmacovigilance needs to be improved in Sub-Saharan Africa, as many of its nations lack the infrastructure and resources to monitor medication and vaccine safety, and healthcare providers in these areas are frequently unaware of safety reporting obligations. With the rapid discovery/innovation of various COVID-19 vaccines, the need for stronger pharmacovigilance system is a priority

In this round table discussion, the panelists will discuss pharmacovigilance protocols in Sub-Saharan Africa. In essence, why it is necessary to manage drug safety and why pharmacovigilance needs to be improved, especially with the recent introductions of various types of COVID-19 vaccines. In addition, they will discuss the role pharmacovigilance can play in reducing vaccine hesitancy seen in most Sub-Saharan countries. They will also explore the challenges and concerns of the healthcare system in Sub-Saharan Africa in managing pharmacovigilance.


Frider Chimimba- Chairperson of Pharmacy and Medicines Regulatory Authority (PMRA), Malawi

Mrs. Frider Chimimba, was one of the pharmacists involved in setting up the National Pharmacovigilance Centre in Malawi in 2015, in collaboration with the National Regulatory Authority (PMRA). With a small team of four Pharmacists, they successfully managed to meet the requirements for Malawi to become a full member of the WHO International Drug Safety Monitoring Programme in March 2019.

She is also involved in research work focusing on Pharmacovigilance related baseline and drug utilization studies. From 2016, under PMPB, she has been involved in the project titled “Strengthening Pharmacovigilance in Malawi” in collaboration with GSK and conducting nationwide training of post-service healthcare workers on Pharmacovigilance under Global Fund.

She is a trained Pharmacist from the University of Dar-es-Salaam, Tanzania and for over twenty years worked with different organizations in Community pharmacy in Malawi. In 2006, she obtained an MSc in Pharmaceutical Services and Medicines Control at the University of Bradford UK, followed by MSc Clinical Research at Cranfield University, UK in 2013.

Dr. Helen Ndagije – Director Product Safety of the National Drug Authority, Uganda

Dr. Helen Ndagije, a pharmacist and clinical epidemiologist, is the Director of Product Safety at the National Drug Authority in Uganda. She is the President of the African Society of Pharmacovigilance, holds a master’s in business administration and a doctorate in public health. She is known for having introduced a decentralized system of pharmacovigilance in Uganda. She has also been the Vice-Chairperson of the African Vaccine Regulator’s Forum(AVAREF), a network that has seen the regulatory system for clinical trials of medicines and vaccines uplifted in the last 10 years. The WHO supported the AVAREF initiative of the 24 member countries meets annually and the last meeting was hosted by Uganda.

In August 2014, Helen also participated as a member of the expert panel to advise WHO of the ethical considerations for the use of unregistered interventions for the Ebola Viral Disease. She is also a member of the Tuberculosis Technical Expert group and various such other groups. Currently, Helen is also part of the East African Community Pharmacovigilance Expert working group.

Previously, Helen was a clinical trial manager for a project by the Medical Research Council in Uganda; Development of Anti-retroviral Therapy, after her excellent performance and completion of a phase II microbicide project in Uganda.

Henry Zakumumpa- CARTA Graduate

Henry Zakumumpa is a Health Systems Researcher at Makerere University and has specialized in HIV and health systems with his academic background being in the social sciences. His PhD research focused on the sustainability of antiretroviral therapy (ART) scale-up implementation in Uganda and was jointly supervised by Johns Hopkins University, Bloomberg School of Public Health, and Makerere University. In early 2017, Henry was a Carnegie Corporation of New York Fellow at Michigan State University.
Henry is a two-time fellow of The German Academic Exchange Service (DAAD) at the University of Kassel (2010) and the University of Oldenburg (2009). He has been Principal and Co-Investigator on
research projects funded by Bill & Melinda Gates Foundation, USAID, WHO, Wellcome Trust (UK) and Population Council (US). Henry has published extensively on differentiated HIV service delivery in esteemed international journals such as Implementation Science, Global Health Action, BMC Health Services Research and Global Health Research and Policy.

Felix Khuluza- CARTA Graduate
Dr. Felix Khuluza, is a registered pharmacist, health economist and pharmaceutical supply chain specialist. He has over eight years of experience in conducting research on the pharmaceutical supply chain and Quality of Medicines in Malawi. Dr. Khuluza is a holder of PhD in Pharmacy from the University of Malawi, a Master of Health Economics from the University of Queensland-Australia and an honors degree in Pharmacy from the University of Malawi. He is a CARTA fellow and EDCTP fellow.
He has been engaged by the Ministry of Health and Pharmacy and Medicines Regulatory Authority (PMRA) in reviewing and drafting of laws, policies and regulations related to the pharmacy profession in Malawi. His career has been shared between hospital pharmacy, retail pharmacy and pharmacy education. In pharmacy education, he is involved in undergraduate and postgraduate training of students with the University of Malawi, and supervision of postgraduate students registered with international universities.
Dr. Khuluza is the current head of the Pharmacy Department at Kamuzu University of Health Sciences (formerly College of Medicine-University of Malawi). He has won several research and academic grants including CARTA re-entry grant and EDCTP early career awards.

Moderator: Johan Ellenius- UMC

Johan Ellenius joined Uppsala Monitoring Centre in 2012. Before that he was a senior lecturer and programme director at Karolinska Institutet in Stockholm for eight years. A background in Computer Science and a strong interest in medical science and research led to him to obtaining a PhD in medical informatics at Uppsala University in 2000. Johan Ellenius has numerous scientific publications and patents in methods using machine learning such as artificial neural networks for addressing issues in clinical decision support.

At UMC, he serves as a team manager and senior researcher, focusing on various aspects of data analysis in both structured and unstructured information, guided by the overall vision of safer patients. His primary research interest is within the field of medical decision support.

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