Strengthening the regulatory system and ethics ecosystem around vaccine and immunisation

ITM aims to support the implementation of capacity development of the Rwanda FDA, the Rwanda NEC and the National Immunisation Programme in a system strengthening and sustainable approach, and this includes the following action:

-Providing support for the strengthening of pharmacovigilance activities (e.g., active and passive reporting, AEFIs, signal detection etc.) in Rwanda;

-Providing support for the strengthening of operational research capacity in the pharmacovigilance programme, i.e., for secondary use of routine data in research, ideally linked to PhD research;

-Providing support/mentoring to build regulatory and ethics capacities around vaccines and immunisation for Rwanda FDA, Rwanda NEC, and RBC (National Immunisation Programme);

-Develop an “ethics lab” that allows ongoing ethics reflection on emerging themes and challenges in research ethics and in bioethics more in general, resulting in expert reports or publications.

Enabel on the other hand, in collaboration with its public and private partners in the region will facilitate ITM in creating conducive environment for performing the assignment. Enabel will also:

-Communicate to the expert the relevant documentation available for the research;

-Support, as much as possible the experts in their mission in terms of logistics;

-Contribute to the brainstorming sessions, workshops, capitalisation notes and recommendations drafting.