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.

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

Panellists:
- 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

Para abogar por una implementación más amplia y armonizada de bioexenciones basadas en el sistema de clasificación biofarmacéutica (BCS) en los países de América Latina, la FIP está apoyando a los líderes regionales en la sensibilización sobre esta vía reguladora basada en la ciencia diseñada para acelerar la aprobación del mercado de productos farmacéuticos genéricos seguros y eficaces. La segunda parte de esta serie de seminarios web diseñados específicamente para la región de América Latina destaca ejemplos de vías de aprobación regulatoria de bioexenciones basadas en BCS que se implementan actualmente en países seleccionados de América Latina. Los expertos abordarán la base legislativa de las regulaciones de bioexenciones y discutirán las oportunidades de armonización dentro de la región.

Este webinar tiene los objetivos:

• Diferenciar entre la bioequivalencia in vivo y las estrategias reguladoras de bioexención basadas en BCS para la aprobación de medicamentos genéricos.
• Comprender las implicaciones para la salud pública de la vía reguladora de la bioexención basada en BCS.
• Delinear oportunidades y desafíos para la implementación de un proceso armonizado de aprobación regulatoria de bioexenciones dentro de la región de América Latina.
• Delinear las contribuciones de solubilidad, permeabilidad y disolución para aplicaciones de bioexención basadas en BCS.

Moderadora:
-Talita Ferreira, Coordinadora de Proyectos de bioexención en Latinoamérica FIP

Panelistas:
-Alfredo García Arieta, Jefe del Servicio de Farmacocinética y Medicamentos Genéricos AEMPS
-Andrés Figueroa Campos, Gerente SD Registro Sanitario de Productos Farmacéuticos Bioequivalentes
ANAMED ISPch–Agencia Nacional de Vigilancia Sanitaria de Chile
-Jorge Iliou, Dirección NVVS de Paraguay
-Alexis Aceituno,Jefe SD Registro Sanitario de Productos Farmacéuticos Bioequivalentes ANAMED ISPch–ANVSChile
-Miguel Angel Cabrera Prof. Asociado Central University of Las Villas

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.

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

Panellists:
- 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