Global Health Protection Programme
Global Health Protection Programme
The Paul-Ehrlich-Institut (PEI) is committed to the Global Health Protection Programme (GHPP) of the German Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) through its projects BloodTrain and RegTrain-VaccTrain.
The Paul-Ehrlich-Institut (PEI) plays an important role in the Global Health Protection Programme (GHPP) of the German Federal Ministry of Health (BMG). The overarching objective of the programme initiated by the BMG is the improvement of health world-wide. Germany supports its partner countries in the management of international epidemics and the establishment of robust health systems.
In the GHPP projects BloodTrain and RegTrain-VaccTrain, experts at the PEI contribute to strengthening national health systems in Africa and implementing international health standards. Both projects are directed mainly to regulatory authorities in Africa. Their aim is to improve access to save medicinal products in these countries, in particular to vaccines, blood and blood products. The focus of their works is on the development of the regulatory oversight and control of clinical trials, pharmacovigilance and the blood supply chain.
Besides the Paul-Ehrlich-Institut, the BMG has assigned the task of implementing the GHPP programme to the Robert Koch-Institut (RKI), the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and the Bernhard-Nocht-Institut for Tropical Medicine (BNITM).
Cooperation with African Partner Organisations
The Paul-Ehrlich-Institut (PEI) is closely networked with global partner organisations such as the New Partnership for Africa's Development (NEPAD) and the World Health Organization (WHO). These partners have assumed secretarial functions for the initiative of African Medicines Regulatory Harmonization (AMRH) and the African Vaccines Regulatory Forum, (AVAREF). The cross-institution and cross-border co-operation supports the aim of strengthening and harmonising regulatory structures and processes in African countries.
BloodTrain Project
BloodTrain Project
Objectives
- Improving the availability, safety, and quality of blood and blood products
- Supporting the establishment of a regulatory structure and its adaptation to crisis situations in partner countries
- Supporting the establishment of a regulation of in vitro diagnostics for safe and reliable blood testing
Description of the project
Blood and blood products are important medicinal products. They have been recognised as essential by the WHO. But for many countries in Africa, blood reserves are not available in sufficient quantity and quality. However, performing, processing and storing a blood donation and testing of the blood donation are often inadequately regulated or monitored, or these steps are not performed altogether. This, for example, dramatically increases the risk of a transfusion-related transmission of HIV or hepatitis virus.
The GHPP BloodTrain team is supporting african partner countries in developing further capacities to improve access to safe blood and blood products for patients. A key element in this context is a functioning regulatory structure, which guarantees the availability, safety, and quality, of blood and blood products. In addition, countries should also be able to respond effectively to crisis situations with sufficient safe blood supplies.
The project is managed by
Dr Jens Reinhardt
Deputy Head of Section HZG 2 Quality Assessment Coagulation Products and Gene Therapy
Paul-Ehrlich-Institut
Phone: +49 6103 77 4022
Email: BloodTrain@pei.de
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RegTrain-VaccTrain Project
RegTrain-VaccTrain Project
Objectives
- Supporting the development of scientific and regulatory capacities for the monitoring and evaluation of clinical trials in order to permanently improve universal access to safe medicines, in particular vaccines
- Supporting the establishment of sustainable structures to monitor the safety of medicinal products, in particular vaccines (pharmacovigilance)
- Creating of sustainable structures and capacities to be adequately prepared for future health crises
Description of the project
The Ebola epidemic in West Africa has shown that vaccines and therapeutic medicines designed to curb an epidemic as fast as possible are not available or at least not to a sufficient extent.
Health systems are often unable to handle such situations. The indispensable clinical trials can at best be organised only with limitations and delays.
One of the purposes of RegTrain-VaccTrain is to make a contribution to the set-up of the necessary scientific and regulatory capacities in the areas clinical trials and pharmacovigilance locally. This involves analysing and evaluating the current situation in the partner countries and identifying the weaknesses. Then, the establishment of regulatory structures and capacities of institutions in the partner countries shall be supported by co-ordinated trainings and enforced co-operation.
The project is managed by
Dr Heidi Meyer
Head of Section International Coordination, Regulatory Service
Paul-Ehrlich-Institut
Phone +49 6103 77 3106
Email: VaccTrain@pei.de
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