Immunization standards

African Vaccine Regulatory Forum (AVAREF)

Background

The authorization of clinical trials function was initially considered to be important only for producing countries. However, it is recognized that developing countries that are target for clinical trials should have the expertise and capacity to review clinical trial authorizations, to authorize the importation of clinical batches and to monitor clinical trials. Furthermore, it is important that NRAs have the capability of assessing clinical data and product quality in registration dossiers. With recent changes in regulatory framework and different regulatory strategies used by manufacturers, developing countries that use the new vaccines will license products that have not been licensed in the country of manufacture.

The regional approach

While NRAs of manufacturing countries need to develop a permanent infrastructure to review clinical trial applications and evaluate clinical data, countries that are target for clinical trials may not need to invest in permanent resources at the same level. However, when a clinical trial is to take place, the NRA of the target country would need the resources available within a short period of time.

It is important to establish a system to support NRAs in the assessment of clinical trial applications and monitoring of clinical trials as well as to evaluate clinical data in registration dossiers. This system should optimize the use of regional resources and expertise, and should be recognized as a regional advisory panel for regulatory consultations.

This network would serve as a source of expertise for countries that have to make regulatory decisions for which they are not prepared and as a forum where countries can discuss issues with peers as a means to build on the expertise available in the region and strengthen the capacity of weaker countries.

Objective

To provide a resource of expert advise to regulators to support their regulatory system for evaluation of vaccines. This forum may be considered as an "ad-hoc" scientific advisory body that will help regulators make an informed regulatory decision with regards to authorizations of clinical trials, evaluation of registration dossiers, or any other challenging issues regarding evaluation of vaccines.

Regular schedule

April and October of every year

Participants

  • NRA staff responsible for the review of clinical trial applications and registration dossiers
  • Representatives from Ethics Committees or Scientific Advisory Committees as applicable
  • Designation of participants will be requested from the NRAs according to clear criteria specifying that the candidates will attend a series of meetings with pre-defined schedule.

Format

Information session and regulatory discussions. According to the stage of development of the vaccine different kinds of presentations will be included i.e. vaccine developers, clinical trial sponsors, vaccine manufacturers. Furthermore, experts in relevant areas of expertise will be invited by WHO to make presentations and assist regulators. There will be information sessions and sessions only for regulators, WHO staff and experts brought by WHO to provide a non-threatening environment for regulators to feel free to discuss their concerns, doubts, weaknesses and openly ask questions to experts and colleague regulators.

Topics

Vaccines going to clinical trials, vaccines in clinical trials, vaccines submitted for registration. The topics will involve characteristics of candidate vaccines, epidemiology, immunology, serology, and other elements that may have an impact on the efficacy and safety of the vaccine. Also new guidelines, recommendations, and regulatory expectations will be included.

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Last update:

22 December 2011 15:06 CET