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Facilitating access to medicines: Biowaiver regulatory case studies from Latin America
To advocate for a broader and more harmonized implementation of Biopharmaceutical Classification System (BCS)-based biowaivers in Latin American countries, the FIP is supporting regional leaders in raising awareness of this science-based regulatory pathway designed to accelerate market approval of safe and effective generic pharmaceuticals. The second part of this series of webinars designed specifically for the Latin American region highlights examples of BCS-based biowaiver regulatory approval pathways currently being implemented in select Latin American countries. Experts will address the legislative basis for biowaiver regulations and discuss harmonization opportunities within the region.
This webinar has the objectives:
• Differentiate between in vivo bioequivalence and BCS-based biowaiver regulatory strategies for generic drug approval.
• Understand the public health implications of the BCS-based biowaiver regulatory pathway.
• Outline opportunities and challenges for the implementation of a harmonized biowaiver regulatory approval process within the Latin American region.
• Outline solubility, permeability, and dissolution contributions for BCS-based biowaiver applications.
Talita Ferreira, Coordinator Latin America Biowaiver Project International Pharmaceutical Federation (FIP), Brazil
Eduardo Agostinho Freitas Fernandes, Specialist in health regulation and surveillance ANVISA - Brazilian Health Regulatory Agency, Brazil