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      Current Challenges in Argentina, Brazil and Mexico in Fremont


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      January 14, 2019

      Monday  10:00 AM - 11:30 AM

      Fremont, California, United States
      Fremont, California

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      EVENT DETAILS
      Current Challenges in Argentina, Brazil and Mexico

      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.

      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 licensed products. The current regulatory climate in Latin America is discussed in detail and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms in the region are outlined.

      Course content will explain how Latin America interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. Additionally, participants will learn how personnel can best address the conflicts, which arise and the best course for resolution.

      Areas Covered in the Session
      Glossary of Terms
      Defining the Opportunity: Overview of Latin America
      Country Facts: Argentina, Brazil, Mexico
      Latin America's Regulatory Structure for the Life Science Product Industries
      Brazil - ANVISA Structure & Insight to Operations

      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.

      Cost: Payment required - $150. One Attendee

      Categories: Conferences & Tradeshows | Education | Health & Wellness

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.
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