Center for Professional Innovation & Education, Inc., Los Angeles, CA
Nov. 6 & 7, 2013
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
The current regulatory climate in Latin America will be illustrated in depth and will include workshops with real world scenarios. Sessions also include Latin American health agencies implementation of ICH standards and how they relate with FDA & European Medicines Agency (EMA) standards.
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