Those taking part in the project, known as PROFORMA, are researchers from Karolinska Institutet, researchers and experts from universities and regulatory authorities in Ethiopia, Kenya, Tanzania and Rwanda, and some regional and international stakeholders in the field of drugs safety. The total project funding is EUR 6 million, of which the major part is provided by the EU Framework Programme for Research and Innovation-Horizon2020, via the European and Developing Countries Clinical Trials Partnership (EDCTP). Among other significant funding bodies is the Swedish International Development Cooperation Agency (SIDA).
“The main aim of this project is to strengthen the national infrastructures for drugs safety monitoring in our partner countries in Africa. This involves developing regulatory capacity for routine surveillance and reporting, and training of staff working in healthcare and medical services and regulatory authorities,” says Eleni Aklillu, senior researcher at the Department of Laboratory Medicine at Karolinska Institutet and scientific coordinator for the project.
Right now, she is in Ethiopia attending the national kick-off meeting for PROFORMA.
PROFORMA is estimated to last five years. The project also involve training at Master’s and postgraduate level and exchange of knowledge in general between researchers and experts.
“The increasing number of clinical trials and different types of mass drug administration and vaccination programmes in African countries underlines the need to strengthen pharmacovigilance infrastructure. One important tool is to improve collaboration between the Medical Universities and regulatory authorities in the countries concerned, and we’ve already made good progress in this area during the few months we’ve been working on the project,” says Eleni Aklillu.
Facts about PROFORMA
Project title: Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa (PROFORMA)
Project funding: EUR 6 million, to be spread over five years, of which approx EUR 3 million will be funded by Horizon2020/EDCTP. Other funding bodies are SIDA, Karolinska Institutet, the Pharmacy and Poisons Board (Kenya), Muhimbili University of Health and Allied Sciences (Tanzania) and the Tanzania Food and Drugs Authority.
Project period: 1 March 2018 – 28 February 2023 (60 months)
Coordinator: Eleni Aklillu, Associate Professor, Karolinska Institutet.
contact for scientific information:
Please address any further queries to:
Dr Eleni Aklillu, Associate Professor, Scientific Coordinator
Telephone: +46-8-585 878 87 or +46 735116131
Mobile number when travelling: +251-968101763
Hanna Gador, Project Administrator
Tel: 08-585 838 01
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