PHARMACEUTICAL
REGULATORY AFFAIRS
IN LATIN AMERICA

Conference Date: 08-10 Nov 2010
Conference Ref: A11-6010
Fee: £1620 + VAT
Venue: The Cavendish Hotel, London

A comprehensive review of the evolving regulatory environment, emphasising the challenges and opportunities for the Pharmaceutical Industry in key Latin American countries

INTRODUCTION

This seminar can be viewed both as an Introductory and a Refresher course and will provide you with:

• An up-to-date coverage of the requirements that underpin successful marketing authorisation applications for pharmaceutical products across Latin America
• The official and regulatory information
• Interpretation and alternatives to local and specific legal requirements
• Hands-on experience in the region
• An overview of the regulatory aspects of site inspections in Brazil, Mexico and Columbia
• Requirements for the marketing of NCE Biological Products, Generic drugs and OTC medicines
• Interactive workshops by putting learning into practice through case studies

WHO SHOULD ATTEND

This seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and in-market regulatory compliance including:

• Scientists and Technical Personnel in:
• Regulatory Affairs
• Registration Departments
• Medical Directors
• Analytical Research and Development
• Quality Assurance
• New Business Development Departments
• Regulatory Authorities

Chairman:
Arturo Gonzáles-Martinez, PhD Director, Regulatory Affairs GlaxoSmithKline, Mexico

Speakers:
Sofia Nuñez, BSc Regional Regulatory Affairs Manager - Latin America, Merck & Co., Inc.,Mexico
Adriana Serrão Guilherme Director, Regulatory Affairs, GE Healthcare, Brazil

The following topics will be covered during the 3 days:

• Latin America Demographics and Market Characteristics
• Currently Applicable Legislation for Key LA Countries
• Product Marketing Authorisation Requirements: NCE similar Drugs and Generics
• Stability Requirements
• Site Inspections
• Packaging and Labelling
• Marketing Authorisation Modifications Requirements
• InteractiveWorkshops:
• Putting Learning into Practice

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