Business Development

Current Challenges in Argentina, Brazil and Mexico 2019

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

Manufacturing 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

Speaker Profile

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.,-brazil-and-mexico-200554live?copybook-Jan-Seo-2019

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