Liberia has approved its first pharmacovigilance regulation. It was presented alongside the updated regulation on clinical trial monitoring to more than 150 stakeholders. The Liberia Medicines and Health Products Regulatory Authority (LMHRA) developed these and related guidelines supported by the VaccTrain 2.0 team at the Paul-Ehrlich-Institut (PEI). Following the subsequent…
The three-day workshop organised by BloodTrain Next Generation and the Africa Society for Blood Transfusion (AfSBT) in Nairobi, Kenya, in October 2024 was well received by the 25 participants from 17 countries. They learnt how blood establishments can validate their critical equipment and processes, and what regulatory authorities need to…
Advanced course for two trainers from Zimbabwe The Medicines Control Authority of Zimbabwe (MCAZ) is one of the well-established medicines regulatory authorities in Africa. The MCAZ has recently achieved the World Health Organization (WHO) Maturity Level 3. As a certified Regional Center of Regulatory Excellence (RCORE) for clinical trials, the…
For three days, 21 regulators deepened their expertise in the regulatory assessment of in vitro diagnostic medical devices (IVD). The aim was to strengthen their monitoring and authorisation in their respective National Regulatory Authority (NRA) institutions. NRA-professionals from 14 African countries took part in the workshop in Rwanda. This training…
Ghana aims to establish official lot release for vaccines and biological products Five Regulatory Officers from the Food and Drugs Authority of Ghana (FDA Ghana) took part in a two-week training at the Paul-Ehrlich-Institut (PEI) in February 2024. The participating team covered a range of expert areas:…
The VaccRelease project supports African partner countries in establishing reliable official lot release to monitor the safety of vaccine lots. This includes: technical advice on analysing weaknesses using the WHO Global Benchmarking Tool, developing country-specific regulatory structures such as regulations, guidelines, and standard operating procedures, building competencies as needed. Training…
‘We need to collaborate! Let’s go far together.’ Under the leadership of the African Union, the African continent is working hard to expand its own vaccine production. At the same time, this requires strict state control and monitoring of locally produced vaccine lots. As for regulatory authorities and official control…
Since 2019, the World Health Organization (WHO) has included the regulation of blood and blood products in its global assessment system for medicine authorities, the Global Benchmarking Tool (GBT). Until now, no official WHO benchmarking using the extended GBT + Blood tool has been performed. However, the self-assessment using this…
Haemovigilance comprises a complex system for monitoring the entire blood transfusion chain from blood collection to transfusion and the follow-up of transfused patients. It serves to ensure the safety and improved use of blood and blood products. By working on the development of haemovigilance systems in Africa, BloodTrain has gained…