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Announcement

Publications on EU funding and African regulatory oversight for vaccine trials

Published on 5 June 2009

Report EU conference Challenges for the Future – Research on HIV/AIDS, Malaria and Tuberculosis
On 13 and 14 November 2008, over 350 representatives of stakeholders participated in the International Conference “Challenges for the Future – Research on HIV/AIDS, Malaria and Tuberculosis” with the aim of increasing the impact of EU-funded research on controlling poverty-related diseases. The full report from this conference is now available and can be downloaded from the Conference website.
Download the report from the conference website

Report Third Meeting of the African Vaccine Regulatory Forum (AVAREF)
From 28-31 October 2008, the third annual meeting of AVAREF was held, bringing together stakeholders involved in vaccine development and regulatory oversight. The report from this meeting is available, which contains a wealth of information of regulatory oversight of vaccine trials in Africa.
AVAREF is working together with among others the US FDA, Health Canada, EMEA to strengthen regulatory capacity and integrate and harmonise the regulatory frameworks in the regions. The report discusses among others joint reviews and inspections by African regulators of multicentre clinical trials of vaccines (cases discussed include a phase III trial of the malaria vaccine RTS,S) which helped to finetune such a joint approach to regulatory oversight within Africa.
One of the results of the meeting was the recommendation to integration existing clinical trial registries. Plans are currently underway to extend the ATM clinical trials registry to become a Pan African Clinical Trial Registry (PACTR). PACRT is also envisaged to be the link among National Regulatory Agencies and Ethics Review Committees of all AFRO countries.

Download the report (PDF)

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