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Novenber 4 & 5, 2008 - Malvern, PA
This course will benefit regulatory personnel, whose responsibilities require knowledge of Latin America’s regulatory environment, focusing on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products. The primary countries covered will include: Argentina, Brazil, Chile, Costa Rica, Dominican Republic, Mexico, Panama, Peru and Venezuela. The course will cover content relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings, and registrations and what is expected in the authorization and dossier maintenance of licensed products.
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This course will benefit regulatory personnel, whose responsibilities require knowledge of Latin America’s regulatory environment, focusing on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products. The primary countries covered will include: Argentina, Brazil, Chile, Costa Rica, Dominican Republic, Mexico, Panama, Peru and Venezuela. The course will cover content relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings, and registrations and what is expected in the authorization and dossier maintenance of licensed products.
Discuss Add this link to... Bury
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