Pharmaceutical Regulatory Affairs in Latin America

In The Rembrandt Hotel, London

£ 1,799 + VAT

Description

  • Typology

    Practical seminar

  • Level

    Intermediate

  • Location

    The rembrandt hotel, london

  • Class hours

    8h

  • Duration

    3 Days

Description

Regulatory requirements for the Pharmaceutical Markets across Latin America including Columbia, Peru, Brazil, Mexico, Argentina, Uruguay, Paraguay, Venezuela, Ecuador, Central America, Chile

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 appliations for pharmaceutical products across Latin America
•The official 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
•Requirements for the marketing of NCE, Biologic and biotechnology products, generic drugs and OTC medicines

Facilities

Location

Starts

The Rembrandt Hotel, London (London)
See map

Starts

On request

To take into account

Why you should attend A comprehensive review of the evolving regulatory environment, emphasising the challenges and opportunities for the Pharma Industry in key Latin American countries The following topics will be covered during the 3 days •Latin American demographics and market characteristics •Current legislation for key LA countries •Product Marketing Authorisation Requirements •Marketing Authorisation Modifications •Stability Requirements •Packaging and Labelling •Advertising regulations •Bioequivalence •Biologic and biotechnology product regulations

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 those working in: •Regulatory Affairs •Registration Departments •Medical Directors •Analytical Research and Development •Quality Assurance •New Business Development Departments •Regulatory Authorities

This seminar can be viewed both as an Introductory and a Refresher course

Questions & Answers

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Subjects

  • Latin
  • Interpretation
  • Marketing
  • Biotechnology
  • Regulations
  • Pharmaceutical Marketing
  • Management
  • Medical
  • Medical training
  • Life Science

Teachers and trainers (3)

Adriana  Serrão Guilherme

Adriana Serrão Guilherme

Director, Regulatory Affairs, GE Healthcare, Brazil

Ana Maria del Rosario Chacόn

Ana Maria del Rosario Chacόn

Global Regulatory Strategy Director

Arturo  Gonzáles-Martinez, PhD

Arturo Gonzáles-Martinez, PhD

Director, Regulatory Affairs GlaxoSmithKline, Mexico

Course programme

Course Overview

Regulatory requirements for the Pharmaceutical Markets across Latin America including Columbia, Peru, Brazil, Mexico, Argentina, Uruguay, Paraguay, Venezuela, Ecuador, Central America, Chile

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 appliations for pharmaceutical products across Latin America
  • The official 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
  • Requirements for the marketing of NCE, Biologic and biotechnology products, generic drugs and OTC medicines
Why you should attend

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

The following topics will be covered during the 3 days

  • Latin American demographics and market characteristics
  • Current legislation for key LA countries
  • Product Marketing Authorisation Requirements
  • Marketing Authorisation Modifications
  • Stability Requirements
  • Packaging and Labelling
  • Advertising regulations
  • Bioequivalence
  • Biologic and biotechnology product regulations

Pharmaceutical Regulatory Affairs in Latin America

£ 1,799 + VAT