Speaker Profile

BIOGRAPHY

Mr. Abebe A. Kassahun (MSc in Medicine Regulatory Affairs, B.Pharm) is a seasoned regulatory affairs professional with extensive experience in pharmaceutical regulation and quality systems oversight. He holds a bachelor’s degree in pharmacy from Mekelle University and a master of science in medicine regulatory affairs from Addis Ababa University.
Since 2016, he has been serving as a senior medicine registration expert at the Ethiopian Food and Drug Authority (EFDA). In this role, he is also a lead GMP auditor for pharmaceutical companies and has audited multiple national and international pharmaceutical manufacturers across various countries.
Mr Kassahun is currently contributing as a clinical data assessor in the AMRH Continental Pilot Listing and Next AMA Projects, and he is supporting the Rwanda FDA Backlog Clearance Project as an external assessor from May 1, 2024, to April 30, 2025.
In addition, he has been serving as the Vice-Chairman of the East African Regulatory Affairs Professionals Association (EARAPA) since 2023, promoting regulatory harmonization and professional collaboration across the region.