FDA COMPLIANCE, MEDICAL DEVICES, CLINICAL DEVICES 2012 - Latin America: Regulatory Compliance Requirements for Life Science Products

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Category Latin America Regulatory compliance;clinical requirements Regulatory;Clinical Trials; GCP; GMP ;FDA compliance; fda regulatory compliance; fda compliance program; fda compliance training

Deadline: January 19, 2012 | Date: January 20, 2012-January 21, 2012

Venue/Country: Grand Hyatt San Francisco 345 Stockton St. San Fra, U.S.A

Updated: 2011-12-05 20:33:48 (GMT+9)

Call For Papers - CFP

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