Pharmaceutical Regulatory Affairs in Latin America
Course
In The Rembrandt Hotel, London
Description
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Type
Practical seminar
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Level
Intermediate
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Location
The rembrandt hotel, london
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Class hours
8h
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Duration
3 Days
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
Start date
Start date
About this course
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
Reviews
Subjects
- Latin
- Interpretation
- Marketing
- Biotechnology
- Regulations
- Pharmaceutical Marketing
- Management
- Medical
- Medical training
- Life Science
Teachers and trainers (3)
Adriana Serrão Guilherme
Director, Regulatory Affairs, GE Healthcare, Brazil
Ana Maria del Rosario Chacόn
Global Regulatory Strategy Director
Arturo Gonzáles-Martinez, PhD
Director, Regulatory Affairs GlaxoSmithKline, Mexico
Course programme
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
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