Immunization standards

Training workshop on clinical trial authorization
18-22 June 2007 in Harare, Zimbabwe

Background

This course was delivered first in Benin, in December 2006. The presentations were translated into English and delivered to anglophone countries in Harare.

Objective

To train regulators and members of ethics committees on the review of clinical trial applications of vaccines.

Participants and trainers

There were representatives from NRA, Ethics Committees and Research organizations from: The Gambia, Ghana, Botswana, Ethiopia, Malawi, Uganda, Tanzania and Zimbabwe. There were investigators from research organizations from Gabon and Zambia (no NRAs or Ethics Committees from these countries).

The facilitators/trainers were from the South African NRA (Gavin Steel), Brazilian NRA (Sergio Nishioka) and WHO (Liliana Chocarro, Modibo Dicko and Dina Pfeifer).

Outcome

There were presentations and also exercises based on case studies used in the previous course. There was a high level of participation and in general the result of the evaluation was positive. The content was assessed, and a report with inputs from participants and facilitators will be discussed internally with regards to content, documents used in case studies and the profile of the audience, to improve the course.

The participants were also asked to present the status of regulation of clinical trials in their countries. These showed significant progress in countries both in terms of coordination between NRAs and Ethics Committees and with regards to the incorporation of model regulatory procedures into the regulatory/legal framework. An important concern that has been proposed for discussion during the next AVAREF meeting is the enforcement of the legal mandate of NRAs with regards to regulation of clinical trials, and the transition period for provisions to deal with ongoing trials that have not been authorized by NRAs.

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