Context The availability, safety and quality of blood and blood products is an essential component of any health care system. The WHO has therefore listed them as essential medicines. Blood products are life-saving for many patients, in particular for women with pregnancy-related complications, children suffering from severe anaemia and people…
Context Vaccines remain the most effective tool for preventing infectious diseases and for improving global health. As only 1% of the vaccines needed in Africa are currently produced in Africa, the continent needs a robust vaccine industry. The COVID-19 pandemic, in particular, has highlighted the need for supranational structures to…
Context The Ebola epidemic and the COVID-19 pandemic have clearly demonstrated that timely access to safe, effective and affordable medicines and vaccines is vital to prevent and fight infectious diseases and protect public health. Many African countries, however, rely on imports of vaccines because national production capacity is insufficient and…
Short Description The Ebola epidemic in West Africa has shown that vaccines and therapeutics are not readily available to control an epidemic quickly. In many cases, health systems are overwhelmed under those conditions. Essential clinical trials can only take place with restrictions and delays, if at all. The RegTrain-VaccTrain project…
Short Description Blood and blood products are important medical products, acknowledged as indispensable by the World Health Organization (WHO). However, in many African countries, there is a deficiency in both the quantity and quality of available blood reserves. The procedures for performing, processing, storing, and testing blood donations are often…
Inspections contribute to blood safety and effectiveness Blood establishments do not only collect blood from donors, they often also have the license to further process the blood into the components needed for therapy. For this processes and manufacturing, blood establishments must comply with requirements – for example, for donor selection…
BloodTrain Haemovigilance Technical Support: Key Steps to Launch Agreement with the partner country on the major next steps and processes. Formation of a small team; the so-called Haemovigilance (HV) Task Team. In this team, all stakeholder groups of the partner country relevant for haemovigilance are represented: The Food And Drugs Authority…
BERC-Africa is an EDCTP2-funded project coordinated by FDA Ghana and supported by local and international partners including the PEI in a concerted effort aimed at bolstering the capacity of African regulators in the area of Clinical Trials. As part of its work package under a consortium agreement, the…
The launch took place in Monrovia on 29 July 2022. The meeting´s aim was to make all relevant stakeholders as well as the public aware of the new regulatory requirements for clinical trials. The new regulation is intended to ensure that all clinical trials conducted in Liberia follow Good Clinical…