Nkusi Steven
Clinical Pharmacist
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About
Regulatory Affairs and Public Health professional with experience in medicines regulation, pharmacovigilance, post-marketing surveillance, and marketing authorization. Experienced in WHO GBT benchmarking, evidence preparation, regulatory system strengthening, and contribution to ML3 achievement. WHO focal point for substandard and falsified medical products.
Experience
Division Manager – Human Medicines & Medical Devices Registration at Rwanda Food and Drugs Authority (Rwanda FDA) (2024-04 – Present)
- Lead medicines and medical devices registration processes
- Oversee regulatory evaluation and decision-making
- Coordinate multidisciplinary regulatory teams
Pharmacovigilance & Post-Marketing Surveillance Analyst at Rwanda Food and Drugs Authority (Rwanda FDA) (2021-06 – 2024-04)
- Supported medicines safety monitoring systems
- Contributed to regulatory safety assessments
- Participated in WHO GBT strengthening activities
WHO GBT Benchmarking Contributor (PMS & MA) at WHO / Rwanda FDA
- Prepared regulatory evidence for WHO benchmarking
- Presented regulatory systems to WHO assessors
- Contributed to ML3 achievement in PMS and MA
WHO Focal Point – Substandard and Falsified Medical Products at WHO
- Coordinated reporting and alerts on SF medical products
- Supported national medicines safety surveillance systems
Chair – Internal Safety Monitoring Committee (Clinical Trials) at Rwanda FDA
- Oversaw clinical trial safety monitoring
Education
Doctor of Pharmacy in Pharmacy
Postgraduate Diploma in Hospital Management
Bachelor of Pharmacy in Pharmacy
