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Facilitating Access to Medicines – Scientific Rationale for the FIP Latin America Biowaiver Project

13 October 2021

To advocate for broader, harmonized implementation of biopharmaceutics classification system (BCS)-based biowaivers in Latin American countries, FIP is supporting regional leaders in raising awareness for this science-based regulatory pathway designed to accelerate market approval of safe and effective generic drug products. The first part of this webinar series specifically designed for the Latin American region centers on the fundamental scientific concepts underlying the BCS-based biowaiver regulatory pathway. Experts will address the different tools that can be applied to generate valid scientific evidence in support of BCS-based biowaiver applications.

In collaboration with Sindusfarma, Legis Consultoria, and Innovation and Biopharmaceutical Evaluation Center. 

This webinar has the objectives:

  • To differentiate between in vivo bioequivalence and BCS-based biowaiver regulatory strategies for approval of generic drug products.
  • To understand the scientific principles guiding the BCS-based biowaiver regulatory pathway.
  • To delineate the contributions of solubility, permeability, and dissolution for BCS-based biowaiver applications.

- Talita Ferreira, Latin America Biowaiver Project Manager, International Pharmaceutical Federation (FIP) - Brazil

- Maria del Val (Marival) Bermejo Sanz, Professor, Miguel Hernández University - Spain
- Isabel González, Professor, Miguel Hernández University - Spain
- Gladys Granero, Professor, University of Córdoba - Argentina
- Pablo González, CEO, Innovation and Biopharmaceutical Evaluation Center, Chile
- Miguel Angel Cabrera-Pérez, Associate Professor, Central University of Las Villas, Cuba