Towards improved processes and timelines for review of clinical trials in the African Region

Towards improved processes and timelines for review of clinical trials in the African Region

First AVAREF TCC and SC Meetings, held in Kigali, Rwanda, 20–23 September 2016

The AVAREF Steering Committee (SC) plays an important role in the development and review of technical documents for use by ethics committees (ECs) and National regulatory authorities (NRAs).  The SC comprises of heads of NRAs and ECs representing all the Regional Economic Communities (RECs) in the African Region and provides leadership and strategic direction for AVAREF through endorsement of all its documents and activities. The SC is supported in its work by a technical coordinating committee (TCC) and technical working groups (TWGs).

The AVAREF TCC and SC met in Kigali, Rwanda, for two days each, back-to-back, from 20–23 September 2016. The two committees reviewed and endorsed an AVAREF Common Process and Timelines for Review of Clinical Trial Applications and an AVAREF communication strategy, Guidelines for joint reviews, as well as the AVAREF 2016–2017 work plan were also discussed. They also discussed and agreed on the use of the AVAREF network to support countries that will be piloting  the malaria vaccine, RTS,S/AS01  and for the use of the WHO Collaborative Procedure to facilitate the national registration of prequalified vaccines including a WHO newly prequalified vaccine against cholera In addition the SC endorsed its terms of reference (TOR) as well as the TCC TOR.

The TCC and SC also learned of and supported work underway to develop electronic platforms to facilitate the collection of clinical trial review times, joint review and the tracking of vaccine products of public health interest.

These first TCC and SC meetings of AVAREF have therefore endorsed important documents to help regulators and ethics committees improve their existing processes and timelines for reviews of clinical trials in Africa.

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For Additional Information or to Request Interviews, Please contact:
Dr Akanmori Bartholomew

Email: akanmorib [at] who.int