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From Regional to Global: The FIP Latin America Biowaiver Project

10 March 2023

In recognition of different regional needs, this event summarizes a new approach for FIP to advance regional priorities that are aligned with FIP’s global objectives. Presentations will highlight the relevance of a Biopharmaceutical Classification System (BCS)-based biowaiver regulatory strategy and outline the regionally-driven approach to implement harmonized biowaiver legislation among Latin American countries. FIP’s role as a facilitator in raising awareness among relevant stakeholder can be adapted to other priorities of different regions that are aligned with FIP’s global vision of a world where everyone benefits from access to safe, effective, quality and affordable medicines.

- Giovanni M. Pauletti, Scientific Secretary, International Pharmaceutical Federation (FIP) - USA

- Steve Estêvão Cordeiro, Technical Officer at the World Health Organization World Health Organization - Switzerland
- Talita Ferreira, Coordinator Latin America Biowaiver Project
ANVISA - Brazilian Health Regulatory Agency - Brazil
- Alexis Aceituno, Head SD Sanitary Registry of Bioequivalent Pharmaceutical Products ANAMED ISPch – Public Health Institute of Chile, National Drug Agency - Chile
- Eduardo Agostinho Freitas Fernandes, Specialist in health regulation and surveillance ANVISA - Brazilian Health Regulatory Agency - Brazil