Pharmaceutical Regulatory Affairs in Latin America

Pharmaceutical Regulatory Affairs in Latin America a comprehensive review of the evolving regulatory environment, emphasising the challenges and opportunities for the Pharma Industry in key Latin Americal countries

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

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 those working in:

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

Programme

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
    u Inspection experience in Latin America
    u Harmonisation efforts in Latin America

Bespoke training

We can customise this course to meet the requirements of your organisation. Contact us to discuss your training requirements.

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Previous customers include...

  • Actavis Biologics Ltd
  • Arrow Farmaceutica Ltda
  • Aspen Pharmacare
  • Astellas Pharma Global Development Inc
  • AstraZeneca
  • Aveva Drug Delivery Systems
  • C.B. FLEET COMPANY INC
  • Chiesi Farmaceutici SPA
  • Eli Lilly & Company
  • Farmaprojects S.A.
  • Fresenius Kabi AB
  • Gilead Sciences
  • GlaxoSmithKline Vaccines & Diagnostics s.r.l.
  • Grunenthal GmbH
  • IHS Global Insight
  • IHS Global Ltd
  • Intendis GmbH
  • LFB Biomedicaments
  • Mundipharma Research Ltd
  • Pliva - Research & Development Ltd
  • Recordati S.p.A.
  • Schwarz BioSciences GmbH
  • Scigen IL Ltd
  • Shire
  • Takeda GmbH
  • Takeda Pharmaceuticals International GmbH
  • UCB Pharma SA
  • Vifor Pharma (International) Ltd
  • Wyeth Pharmaceuticals
  • Xellia Pharmaceuticals AsP