Overview: The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Why should you Attend: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, Biosimilar, Orphan Drugs and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. The course will cover topics relating to full product life-cycle management, as well as, address the structure of the regulatory agencies in Latin America.
Areas Covered in the Session
Glossary of Terms - Defining the Opportunity: Overview of Latin America
Country Facts: Argentina, Brazil, MexicoLatin America's Regulatory Structure for the Life Science Product Industries
Brazil - ANVISA Structure & Insight to Operations
Mexico - COFEPRIS Structure & Insight to Operations
Who Will Benefit
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
Global Business Development Personnel
Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit
Robert J. Russell For the past 9 years, He has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance.
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