AVAREF Webinar for developers and manufacturers with an interest in conducting multi-country clinical trials in Africa
The purpose of this webinar is to introduce the AVAREF platform and service offering for developers and manufacturers with an interest in conducting multi-country clinical trials in Africa.
For a multicenter, multi-country clinical trial, clinical trial applications (CTAs) will have to be submitted to individual national regulatory authorities (NRAs) and ethics committees (ECs), often in different formats as defined by each country. Reviews will then be conducted individually and at different times before final outcomes are communicated individually to the sponsor.
To optimize the review of multi-country clinical trial applications, promote harmonization of regulatory requirements, practice and processes across countries, as well as build capacity for more efficient oversight, WHO introduced the concept of joint reviews in 2006.
Joint reviews enhance the quality of the reviews of an application submitted to multiple countries, optimize review timelines for such applications, serve as a platform to allow regulators and ethics committees to exchange and validate their findings with peers and also act as a capacity-building tool.
Joint reviews enable NRAs and ECs to collectively prepare a consolidated list of questions for the sponsor and to discuss directly with manufacturer/sponsor of the candidate product, the trial design, safety and other aspects of the proposed trial.
Join the webinar to understand how this works and to find out what the benefits are.
Please note that there is a limit to number of participants. Register early to avoid disappointment.