A 2.5-day intensive course for Africa’s pharmaceutical and regulatory leaders.
Navigating Bioequivalence & Biowaiver Requirements for Generic Drug Manufacturers in Africa
This practitioner-led sprint supports manufacturers, importers, regulators, and CROs to navigate evolving dossier rules for generic drug approvals across WHO ML3 African countries.
As more national regulatory authorities across Africa achieve maturity level 3 (ML3), bioequivalence and biowaiver requirements are reshaping how medicines are evaluated and registered. This course provides practical tools and clarity to meet these expectations confidently.
Through expert guidance, peer discussion, and real case examples, participants will strengthen their understanding of BE and biowaiver pathways, improve dossier quality, and build trust between industry and regulatory agencies.
What You’ll Gain
Participants will gain:
- A clear understanding of BE and biowaiver requirements across ML3 jurisdictions.
- Practical strategies to improve dossier preparation and reduce rejection risk.
- Insight into regulatory reliance mechanisms and how to engage effectively.
- Stronger professional connections between manufacturers, CROs, and assessors.
Preliminary agenda
- Day 1: Scientific and Regulatory Foundations of Bioequivalence
- Day 2: Biowaivers, Dissolution, and Applied Regulatory Science
- Day 3: Strategy, Policy, and Future Directions
Who It’s For
The sprint is designed for professionals leading or supporting regulatory, manufacturing, and policy efforts to advance access to quality-assured medicines across Africa, including:
- Manufacturers & Importers – Generic producers, formulation scientists, and regulatory affairs leads.
- Regulators and Assessors – NRA reviewers, policy advisers, and members of regional harmonization initiatives.
- Contract Research Organizations (CROs) – Clinical operations and data validation experts.
- Industry Associations and Networks – Representatives of generics alliances and pharmaceutical associations.
Faculty & Experts
Dr. Olawale Salami is a physician and clinical research specialist with over 15 years of experience spanning public health, pharmaceuticals, and regulatory science. He is the former Head of Clinical Project Feasibility at SGS, and currently the Head of Clinical Trials at the University of Global Health Equity in Kigali, Rwanda.
Ademola Osigbesan is a pharmacist and global health professional with over 18 years of experience driving equitable access to medicines and diagnostics across Africa, Asia, and Latin America. He is currently a PhD researcher in Development Economics at SOAS University of London, focusing on the political economy of pharmaceutical manufacturing in Africa.
Wyckliff Ombede is a monitoring, evaluation, and learning (MEL) specialist with over 15 years of experience designing and leading MEL systems for donor-funded programs across health, agriculture, governance, and livelihoods sectors.
Guest contributors include national regulators, CRO specialists, and manufacturer case presenters.
Your Investment
Cost: $1950 USD
Cohort limited to 30 participants.