Speaker Profile

BIOGRAPHY

M’sanide Sakala is a distinguished pharmaceutical professional with more than a decade of experience in regulatory affairs, public health policy, and management. He is currently the Chairperson of the Bioavailability/Bioequivalence (BA/BE) Technical Working Group under the African Medicines Regulatory Harmonization (AMRH) initiative. In this capacity, he plays a pivotal role in standardizing medical product assessment across Africa, ensuring harmonized regulatory practices among member states.
Mr. Sakala had served as a senior resource person at the Zambia Medicines Regulatory Authority (ZAMRA) for over ten years, contributing significantly to the agency’s regulatory framework in the areas of marketing authorisation and clinical trials. He supports National Medicines Regulatory Authorities (NMRAs), including the Botswana Medicines Regulatory Authority (BOMRA), the South African Health Products Regulatory Authority (SAHPRA), and the Rwanda Food and Drugs Authority (Rwanda FDA). In these roles, he provides consultancy services focused on quality assurance and regulatory review processes.
Additionally, Mr. Sakala is a consultant for the World Health Organization Prequalification Team—Medicines (WHO-PQTm) for Bioequivalence. He represents WHO-PQTm on the Bioequivalence Working Group for Generics, part of the International Pharmaceutical Regulators Programme (IPRP), where he contributes to international regulatory harmonization efforts. He also acts as a key resource person for bioequivalence matters within Zazibona, a collaborative initiative among Southern African medicines regulatory authorities.
Mr. Sakala’s career spans the full spectrum of the pharmaceutical industry, giving him a comprehensive understanding of its complexities. His experience includes two years in clinical settings, five years in logistics and essential product quantification, and more than a decade in medicine regulation. This diverse background enables him to approach pharmaceutical challenges from multiple perspectives, encompassing production, distribution, and public health policy.