Helen Ndagije

PhD, FISoP, Director Product Safety Uganda National Drug Authority

Dr. Helen Byomire Ndagije is a Ugandan Pharmacist with a doctoral degree in Public health and
over a decade of Pharmacovigilance achievements in academia, regulation, research and
policy. She holds a Master’s degree in Business Administration from Herriot-Watt University, UK
and a PhD degree from the Université Catholique de Louvain, Belgium. She joined the National
Drug Authority as the Head of the Drug Information Department in 2006 and currently serves as
the Director Product Safety at NDA and the head of the National Pharmacovigilance Center in

She is the outgoing President of the African Chapter of the International Society of
Pharmacovigilance (ISoP). She served as the local host for the 40th annual meeting of National
Pharmacovigilance Centres participating in the WHO Programme for International Drug
Monitoring in Kampala. She has chaired the Regulatory team of Ugandan national COVID-19
response coordinating committee. She has been a co-reviewer for the UMC pharmacovigilance
Regulatory e-learning course in 2021. She has served on WHO assignments as an advisor for
setting the minimum requirements for pharmacovigilance for countries applying for global fund
grants as well as an assessor of regulatory system assessments using the WHO Global
Benchmarking of the National Regulatory System on the African continent. She has contributed
to a number of publications on Pharmacovigilance in reputable journals.

She is an academic supervisor and mentor in pharmaceutical regulation for students at Makerere University Kampala (MUK) and Mbarara University of Science and Technology (MUST) where she is contributing to the incorporation of Pharmacovigilance curriculum at all levels.