Navigating Latin American Regulatory Compliance Requirements for Clinical Trials
Course - Los Angeles, CA, United States
This training sessions highlight the implemented regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil, Chile, and Peru.
The course will cover topics relating to pre-clinical and clinical requirements, as well as presenting the matrix of regulatory agencies in Latin America. Sessions will include:
Descriptions of the methods by which counterpart agencies approve product submissions and registrations
What is expected in the authorization and application submission of licensed products
Part 11 application of electronic record systems and case report form regulations Discussion on importing and exporting your test article including logistic considerations
Common pitfalls that have caused regulatory difficulties for global health care product providers in the region
Responding to your host countries regulatory concerns and providing the FDA with this information
(Courtesy of Los Angeles Airport LAX, via travellinksdirectory.com)
Navigating Latin American Regulatory Compliance Requirements for Clinical Trials
Wed, Nov 06, 2013 - Thu, Nov 07, 2013
The Hilton Los Angeles Airport (LAX)
5711 West Century Blvd., Los Angeles, CA 90045, United States
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