FDA Compliance, Medical Devices, Clinical Devices 2012 - Latin America: Regulatory Compliance Requirements for Life Science Products

This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be successful in working with the regulators.

Why You Should Attend:

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. Other countries such as Chile, Costa Rica, Dominican Republic, Panama, Peru and Venezuela will be discussed. The course will cover topics 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 the wide array of licensed products.

Who will benefit?

This course will be beneficial to:

Regulatory personnel whose responsibilities require knowledge of Latin America's regulatory environment
Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant.
QA / QC Personnel
Global Supply Chain personnel
Clinical / Pharma & Device personnel
Manufacturing personnel
Global Business Development personnel
Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization