Paul-Ehrlich-Institut trains regulators from Ghana and Zimbabwe in pharmacovigilance

Since 2016, the PEI has been involved in the "Global Health Protection Programme" (GHPP) of the Federal Ministry of Health (BMG). "RegTrain-VaccTrain" is the name of a project within the GHPP which has the responsibility to train regulators in the area of vaccines – an important group of medicines for health protection. The five African countries, Gambia, Ghana, Liberia, Sierra Leone, and Zimbabwe, are supported in setting up sustainable structures for monitoring these medicines. Up to now, adverse effects of medicines are not yet systematically recorded in some African countries during clinical trials or after the marketing authorisation has been granted. However, this is imperative for providing the population with safe medicines. The programme also includes training two regulators from the two partner countries, Ghana and Zimbabwe to become educators in the field of pharmacovigilance. The aim is that these regulators transfer their knowledge to their own authorities and, if possible, also to those of their neighbouring countries.

PEI trainee programme Source: H. Stoll / PEI

In the eight-week training course, the participants learn how the area of pharmacovigilance in Germany and the European Union is regulated and elaborate suggestions as to which knowledge they will require and will be able to implement for regulatory affairs in their own countries to improve the pharmacovigilance system in their countries in a targeted manner. In doing so, they closely exchange information with the experts from various divisions of the PEI. "What we are also hoping for from the exchange within the RegTrain-VaccTrain Project is to gain deeper insights as to how the area of pharmacovigilance is regulated in our partner countries. That way, we can find out where we can provide our support with our expertise", said Dr Christoph Conrad, project manager of the GHPP Project RegTrain-VaccTrain at the PEI.

During their stay in Langen, the two regulators are also preparing training documents for their colleagues in Africa. To be well prepared for the transfer of knowhow on site, Ashie and Nyamandi are participating in didactics course in Bonn for several days, together with some African trainees of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). PEI and BfArM are closely co-operating in the extended project RegTrain. While the PEI covers the areas of clinical trials and pharmacovigilance, the BfArM supports its partners in the field of marketing authorisation.

About the Trainees

Adela Ashie, pharmacist with an academic degree has been working at the "Food and Drugs Authority" (FDA) at Ghana. Her responsibilities as Senior Regulatory Officer in the Division of Pharmacovigilance at that authority include the regular reports on pharmacovigilance and adverse effects.

Tatenda Nyamandi has been working at the "Medicines Control Authority" of Zimbabwe in Harare as regulator for pharmacovigilance and clinical trials since 2014. He has a bachelor’s degree in pharmacy. His responsibilities at the authority include processing incoming safety reports and adverse effects as well as the evaluation of such adverse effects.