Coordinator Prequalification Team (PQT) Regulation of Medicines and other Health Technologies (RHT), World Health Organization (WHO)
Mr. Mubangizi is a senior regulator with experiences in the regulation of pharmaceutical products, Vaccines, Vector Control Products and In-Vitro Diagnostics. He is currently the Coordinator of Prequalification Team (PQT) within the unit of Regulation of Medicines and other Health Technologies (RHT) in the Department of Essential Medicines and Health Products (EMP) of World Health Organization (WHO), based in Geneva, Switzerland. Prior to joining the World Health Organization (WHO) in 2008, Mr. Mubangizi had served as the Chief Inspector of Drugs (1996 - 2008) where he was one of the founder staff of Uganda’s national medicines regulatory agency, National Drug Authority (NDA), in 1994. In 1995, he worked with consultants appointed by WHO to establish a drug registration system for Uganda and subsequently coordinated a team that established the GMP inspection system for local and foreign manufacturing facilities marketing their products in Uganda. He headed the Inspectorate and Licensing Department of NDA Uganda from 1996 to March 2008. He participated in the initiation of medicine regulation harmonization in East Africa and Africa in General. In 2004 he joined a team of external dossier assessors for WHO Prequalification where he was shortly promoted to the level of senior assessor. He has, on behalf of his country Uganda and for WHO Medicines Prequalification Programme, inspected more than 200 sites in African, Europe, Asia, North America and South America for the manufacture of Finished Pharmaceutical Products, Active Pharmaceutical Ingredients, Vaccines and In-vitro diagnostics; national quality control laboratories; and Clinical Research Organizations where bio-equivalence studies are conducted. He has since 2016 been the Coordinator of the WHO Prequalification Team responsible for medicines, vaccines, in-vitro diagnostics, vector control products, male circumcision devices, immunization equipment and cold chain equipment. The team under his leadership has a launched a pilot prequalification of biotherapeutic products including biosimilars.