Parallel V: Bioequivalence Centres & Regulatory Requirements
Tuesday, November 11, 2025
02:00 PM - 04:00 PM
Capacity: 100 attendees
About This Session
This session will discuss the establishment, accreditation, and regulation of bioequivalence centres across Africa. Speakers will highlight the importance of bioequivalence studies in ensuring the quality, safety, and efficacy of generic medicines. The session will also address regulatory requirements, regional harmonisation efforts, and opportunities for collaboration to strengthen local testing capacity.
SPEAKERS
Leigh Verbois
U.S. Pharmacopoeia (USP)
Dr S. Leigh Verbois, Ph.D., is the Lead for Global Regulatory and Laboratory Programs at the U.S. Pharmacopoeia (USP), w...
Felistas Chepwogen
Kenya Pharmacy and Poisons Board (PPB)
NA
Mekonnen Teferi
AHRI Ethiopia
Mekonnen Teferi is a researcher at the Armauer Hansen Research Institute (AHRI) in Addis Ababa, Ethiopia. He is trained ...
Thavendree (Tammy) Gopal
SAHPRA
Thavandree Gopal is the Chief Regulatory Officer of SAHPRA. Tammy has 20 years of experience in the various sectors of t...
Loice Kikwai
Market Access
Loice Kikwai is a pharmaceutical scientist and regulatory affairs expert with over 18 years of global experience in medi...
Luther Gwaza
WHO
Dr. Luther Gwaza is the Team Lead for Norms and Standards for Pharmaceuticals in the Health Products Policy and Standard...
M’sanide Sakala
African Medicines Regulatory Harmonization (AMRH)
M’sanide Sakala is a distinguished pharmaceutical professional with more than a decade of experience in regulatory aff...
SESSION DOCUMENTS
1 file
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African Union Development Agency - AUDA-NEPAD
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