Dr. Helen Byomire Ndagije
Director for Product Safety
National Drug Authority, Uganda
Dr. Helen Byomire Ndagije is a distinguished pharmaco-epidemiologist with over two decades of experience in medicines regulation and clinical research. Holding a PhD in Public Health from the Université Catholique de Louvain, Belgium, she has significantly enhanced pharmacovigilance and regulatory systems across Africa. As the Vice president of the Africa Chapter of the International Society of Pharmacovigilance (ISoP) and Director of Product Safety at the National Drug Authority, Dr. Ndagije’s leadership and commitment have been pivotal in promoting regulatory reliance, developing comprehensive guidelines, and implementing robust pharmacovigilance programs.
Through her contributions to the African Vaccine Regulatory Forum (AVAREF), she has fostered collaboration and mutual trust among regulatory authorities, streamlining processes and enhancing efficiency. Her work with AVAREF and the WHO Global Benchmarking Tool assessments underscores her dedication to strengthening regulatory frameworks and ensuring the safety and efficacy of pharmaceutical products in SubSaharan Africa. Dr. Helen’s insights and extensive experience make her a vital voice in advocating for global and regional cooperation to enhance the pharmaceutical industry and clinical trials landscape, ultimately contributing to better health outcomes in Africa.