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Program Code:
387
Date:
Wednesday, June 26, 2013
Time:
4:00 PM to 5:30 PM
EST
CHAIR
:
Alejandro Bermudez-del-Villar, MA (SCHNON), Project Coordinator, Latin America and Global Program Development, DIA, United States
SPEAKER
(S):
Federico Argüelles Tello, MD (SPKAGY), Comisión Federal para la Protección Contra Riesgos Sanitarios (COFEPRIS), Mexico
Helen Rosenbluth, PhD (SPKAGY), Biosimilar Products, ANAMED (Instituto de Salud Pública de chile-Agencia Nacional de Medicamentos), Chile
Description
This forum will provide an overview of the evolution of biotechnological product regulations from Latin American regulatory personnel and a discussion on how these regulations are modeled after and differ from European (EMA) and US (FDA) regulations.