Research and Markets has announced the addition of the "Pharmaceutical Regulatory Affairs in Latin America" conference to their offering.
Regulatory requirements for the Pharmaceutical Markets across Latin America including Columbia, Peru, Brazil, Mexico, Argentina, Uruguay, Paraguay, Venezuela, Ecuador, Central America, Chile
A comprehensive review of the evolving regulatory environment, emphasising the challenges and opportunities for the Pharma Industry in key Latin American countries
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 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
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
- Biologic and biotechnology product regulations
Latin America demographics and market characteristics
Product classification and definitions
What information must be included in the registration dossiers:
- Technical, legal, stability and labelling requirements for marketing approval
Drug substance and drug product site inspection by Latin American health authorities
Certificates of pharmaceutical product and for GMP
Who should issue?
- How long are they valid for?
- What are the details to watch out for?
How to get approval for:
- Alternative API manufacturers
- Additional packaging sites
How to plan for a valid multi-country stability study:
Comparing the stability requirements of LA countries
- Marketing Authorisation renewal
- Importation requirements
- Biological products
- Stability requirements
- Inspection experience in Latin America
- Harmonisation efforts in Latin America
For more information about this conference visit http://www.researchandmarkets.com/research/hm2wzn/pharmaceutical
View source version on businesswire.com: http://www.businesswire.com/news/home/20161004005714/en/Business Wire
Last updated on: 04/10/2016
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