Pharm. Helen Ndajige
Director of Product Safety,
National Drug Authority, Uganda.
DAY 2: Regulatory Forum
Helen Byomire Ndagije is a distinguished pharmaco-epidemiologist with a wealth of international experience in the field of drug regulation and a deep commitment to enhancing health systems. With a doctoral background in public health and a foundation in pharmacy, Helen has been a driving force since 2006, leading the Ugandan National Pharmacovigilance Centre and the regulation of clinical trials.
Her visionary leadership has propelled the cause of medicine safety onto the national, continental, and global regulatory agendas.
Helen’s impact extends beyond Uganda, as she played a key role in defining the minimum structures required for pharmacovigilance and evaluating these in several countries in Africa and beyond. She served as the Vice Chairperson of the African Vaccine Regulator’s Forum (AVAREF), a network that has played a pivotal role in elevating the regulatory framework for clinical trials of medicines and vaccines over the last decade. Her leadership of AVAREF was acknowledged by WHO in June 2016, and its governance model has been adopted for the African Medicine Regulatory Harmonization Initiative, shaping the future of product development and strengthening regulatory systems in Uganda and across Africa.