Alex Gisagara is a Regulatory Harmonization Expert at the East African Community (EAC) Secretariat. He holds a Master’s degree and a PhD in Biotechnology Innovation and Regulatory Sciences and teaches in the Master’s Programme in Regulatory Science at the University of Rwanda.

Alex previously served as Head of Department at the Rwanda Food and Drugs Authority (Rwanda FDA), where he was responsible for Inspection and Safety Monitoring. He also represented Rwanda in the EAC Medicines Regulatory Harmonization (MRH) Programme from 2012 to 2018, contributing to regional efforts to strengthen and harmonize medicines regulatory systems.

He led the Rwanda FDA team during the PIC/S pre-accession assessment initiated in 2020 to assess compliance with the PIC/S recommendations on quality system requirements for pharmaceutical inspectorates.

Alex has also participated in assessments of Rwanda FDA and the South African Health Products Regulatory Authority (SAHPRA) with the World Health Organization (WHO), serving as an assessor and applying the WHO Global Benchmarking Tool (GBT) for the assessment of regulatory systems for vaccines and medicines.