Join USP and the Gates Foundation for this free webinar focused on developing better business plans for contract research organizations (CROs) conducting bioequivalence studies in Africa, Asia, and beyond. This webinar will introduce a new business planning resource developed by USP, and guide established and emerging CROs in low- and middle-income countries, regulators, stakeholders, and other potential users on its use. The event will also highlight current challenges for CROs, best practices, and tips for navigating regulatory environments.
Speakers
- Dr. Delese Mimi Darko, CEO, Ghana Food & Drugs Authority (FDA)
- Dr. Amanda Lewin, Senior Technical Advisor, USP (Moderator)
- Dr. David Mukanga, Deputy Director of Africa Regulatory Systems, Gates Foundation
- Dr. Porranee Puranajoti, Managing Director, International Bio Service Co
- Chomduen Leeyakart, Acting Quality Assurance Section Chief, International Bio Service Co
- M’sandine Sakala, Chairperson of BA/BE Technical Working Group, African Medicines Regulatory Harmonization (AMRH)
- Hendrick B. Theron, Business Development Executive, FARMOVS
- Mekonnen Teferi, Director, Clinical Trials Directorate, Armauer Hansen Research Institute (AHRI)
Background
Bioequivalence (BE) studies are essential to ensuring that generic medicines match the safety, efficacy, and quality of their brand name counterparts. Yet, one of the biggest hurdles in conducting BE studies in low- and middle-income countries is a lack of financial investment in CROs, which specialize in BE studies. Without critical BE studies to ensure quality, patients are at greater risk of receiving poor-quality generic products.
Bettering the business case for bioequivalence studies in Africa
A guide for contract research organizations conducting BE studies.
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Expanding bioequivalence studies in Africa
Supporting CROs to increase regional production of quality-assured medicines.
Learn more about the project
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