ABOUT THE WORKSHOP SERIES
The U.S. Trade and Development Agency (USTDA) in collaboration with the Corporate Council on Africa (CCA) presents a Workshop Series on Regulatory Convergence for Healthcare Products in Africa.
In this series, we will host four distinct, regionally focused workshops that will set the stage and lead up to a final continent-wide workshop. Each workshop will include a dedicated day for pharmaceutical products and another dedicated day for medical devices. These sessions will convene a select group of key stakeholders, including pharmaceutical and medical device companies, trade associations from both the United States and Africa, as well as regulatory authorities and government agencies from both regions. The primary objective is to foster discussions on the most effective regulatory practices for pharmaceuticals and medical devices, with the overarching goal of promoting harmonization with international standards and achieving convergence in healthcare regulatory systems.
Through this series, we aim to:
- Promote increased collaboration between African health regulatory authorities and U.S. and African industry.
- Facilitate broader market access for healthcare products while enhancing the quality and availability of pharmaceuticals and medical devices across the continent.
- Improve application and approval timelines/processes for entry of health products into market.
- Provide a platform for participants to network and exchange ideas, experiences, and best practices for strengthening health regulatory systems in Africa.
MEET HEALTH REGULATORY DECISION-MAKERS FROM EAST/CENTRAL AFRICA
Countries in Africa that are currently regulating medical devices have generally been regulating medical devices through agencies originally set up to regulate the pharmaceutical industry. These agencies continue to function with design, staffing, and orientation to best suit the pharmaceutical industry. Distinguishing between medical devices and pharmaceuticals regulations is crucial due to the inherent differences between these two industries. This workshop will bring together medical device companies, U.S. and African government representatives and multilateral partners to discuss best practices and identify practical steps needed to strengthen regulatory oversight of medical devices and improve market access for these essential health products in the region.
WHY YOU SHOULD ATTEND
- Understand lessons learned from East and Central African health regulatory harmonization and implementation.
- Learn how digital technologies can be used to improve communication, regulatory process efficiency, transparency and governance to accelerate access to existing and new medical equipment.
- Gain insight on what it will take for countries to transition from the current differentiated policies and guidelines to a more harmonized African health regulatory environment.
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Learn sustainable financing models that support efficient health regulatory systems.
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See live demonstrations of existing and new medical devices available in the African market.
CONFIRMED U.S. & AFRICAN GOVERNMENT REGULATORS:
- Mr. Joseph Rieras, Director, U.S. Food and Drug Administration (FDA)
- Mr. Tshimpaka Kalala Laurent Pattern, Head of Registration Division, Congolese Pharmaceutical Regulatory Authority (ACOREP)
- Mr. Douglas Shaffer, Director, The U.S. Food and Drug Administration (FDA)
- Mr. Salvator Sindayigaya, Pharmacist, Director of Human Medicines, The Burundian Regulatory Authority for Medicines for Human Use and Food (ABREMA)
- Mr. Makomani Siyanga, Director General, Zambia Medicines Regulatory Authority (ZAMRA)
- Dr. Fred Siyoi, CEO, Pharmacy and Poisons Board Kenya (PPB)
CONFIRMED SPEAKERS:
- Mr. Jackson Kiberenge, Tanzania Medicines, and Medical Devices Authority (TMDA)
- Mr. Steve Kipkoti, Senior Regulatory Affairs Specialist, Medtronic & MEDAK Chair
- Ms. Philana Mugyenyi, Director, Government Affairs & Market Access, GE Healthcare
- Dr. Kenneth Otieno, MD, Africa, Gradian Health Systems
- Mr. Laurent Patern Tshimpaka K. Regulatory Affairs HOD, Congolese Pharmaceutical Regulatory Authority (ACOREP)
- Dr. Kanyenje Gakombe, Chair, Kenya Healthcare Federation
- Mr. Thomas Kisimbi, Project Leader, Boston Consulting Group (BCG)
- Mr. Steve Kipkoti, Senior Regulatory Affairs Specialist, Medtronic & MEDAK Chair
- Dr. Christopher Odero, Regulatory Policies and Intelligence, Roche
- Mr. Maxwell Okello, CEO, AmCham Kenya
- Mr. Boniface Orang'i, Head of Operations & Customer Service, East Africa, Philips
- Mr. Joseph Rieras, Director, U.S. Food and Drug Administration (FDA)
- Ms. Paulyne Wairimu, Medical Devices and IVD sections, Pharmacy and Poisons Board Kenya (PPB)