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#345: Africa's Evolving Regulatory Landscape
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
145AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-645-L04-P; CME 1.00; RN 1.00

Dialogue between key stakeholders on AMA operationalization, proposals on improved collaboration, regulatory harmonization and convergence, reliance pathways and other strategies for an efficient and sustainable regulatory system in the continent.

Learning Objectives

Evaluate progress made on AMA operationalization including achievements so far with the support of partners; Discuss key insights and lessons from the Continental Pilot; Identify the way forward for successful implementation of revised AU Model Law; Discuss cultivating a sustainable regulatory ecosystem in Africa employing good regulatory practices and agilities as well as prioritizing capacity building.

Chair

Janis Bernat, MSc

Speaker

Panelist
David Mukanga, PhD, MPH

Panelist
Grace Matimba, MS

Panelist
Chimwemwe Chamdimba


Speakers
avatar for Janis Bernat

Janis Bernat

Director, Scientific and Regulatory Affairs, IFPMA, Switzerland
Janis leads cross-functional activities in regulatory science and international health policy for IFPMA, while partnering with policy experts and stakeholders to strengthen the pharmaceutical regulatory environment. She is responsible for guiding the organization’s regulatory team... Read More →
avatar for Chimwemwe Chamdimba

Chimwemwe Chamdimba

African Medicines Regulation Harmonization Programme Head, African Union Development Agency-NEPAD, South Africa
Chimwemwe Chamdimba heads the African Medicines Regulatory Harmonization Initiative at AUDA-NEPAD. She manages the AMRH Programme, supports AMA operationalization, and drives policy reforms connecting regulatory strengthening to local medical product manufacturing. A health policy... Read More →
avatar for David Mukanga

David Mukanga

Deputy Director, Africa Regulatory Systems, Bill & Melinda Gates Foundation, United States
Dr. David Mukanga is Deputy Director Africa Regulatory Systems at the Bill & Melinda Gates Foundation, where he leads the foundation’s Africa regulatory systems optimization portfolio, and the linkage between regulatory systems and health care services. In this role, David supports... Read More →
GM

Grace Matimba

Chief Regulatory Officer, Medicines Control Authority of Zimbabwe, Zimbabwe
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

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