TRACE Project Core Group Meeting: Advancing Coordination and Next Steps

KIGALI – JULY, 2025

The three-day in-person meeting delivered a unified roadmap for strengthening clinical trial oversight through harmonized ethics and regulatory systems, enhanced digital transformation, and sustainable financing models. 

Key outcomes of this meeting were:

• Agreement on next steps for a registration, accreditation and certification framework for Institutional Review boards (IRBs). 

• Progress on a harmonized training curriculum for NECs, coordinated by MRCT.

• Alignment on digital transformation priorities, including user requirements and next steps for enhancing national platforms.

• Building communication and change management across the selected countries

  
  

The countries reaffirmed their commitment to TRACE’s goals, emphasizing peer learning, proactive communication, and engagement with continental efforts such as AVAREF and the objectives of the African Medicines Agency (AMA). As the project advances, TRACE enters a critical implementation phase focused on capacity building, digital transformation, and the strengthening of sustainable and harmonized ethics and regulatory governance systems in participating countries.