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...

  • Aspen Pharmacare
  • Boehringer Ingelheim Vetmedica GmbH
  • Centocor BV
  • Crucell Switzerland AG
  • GALDERMA
  • Ginsana SA
  • ICON
  • Janssen Pharmaceutica NV
  • Kendal
  • LEK Pharmaceuticals d.d.
  • MEDINOVA LTD
  • Merck Serono
  • Merck Sharp & Dohme
  • Mylan Inc
  • Novartis Consumer Health SA
  • Pliva - Research & Development Ltd
  • Procter & Gamble Technical Centres Ltd
  • Recordati S.p.A
  • Riemser Arzneimittel AG
  • Sandoz GmbH
  • SANOFI CHIMIE
  • Sanofi Pasteur SA
  • Science Union SA
  • Shire Pharmaceutical Ltd
  • Statens Serum Institut
  • TARIUS A/S
  • Teva Pharmaceutical Industries Ltd
  • Vifor Pharma AG
  • Waymade Plc
  • Zambon Group SpA

Very interesting and useful

Emmanuelle Crestia, Export Regulatory Affairs Pharmacist, LFB Biotechnologies

Good presentations. General and specific topics of each country discussed. Content and distribution complete.

DIANA HERNANDEZ PRAT, REGULATORY AFFAIRS TECHNICIAN, LABORATORIOS MENARINI

Very interesting and useful for my work.

Norma Steimberg, Regulatory Affairs Manager, DextReg

All in all I enjoyed the course. All information is highly relevant for my work and rest of info was very well presented. I will recommend this course to other colleagues if asked.

Alena Germanenko, Regulatory Professional, Novo Nordisk A/S

Interesting course which gives a thorough basis of requirements. Interactivity and kindness of the speakers was really appreciated.

Sylvie Carbonnel, Regulatory Affairs Coordinator, Sanofi Chimie S.A.

Globally very good and useful in our activities. Good occasion to exchange and discuss particular cases.

Ana de la Vieuville, Regulatory Project Manager, Orphan Europe

I felt that the speakers are interested by their subject and their level of expertise is very good

Marine Joly-Battaglini, Scientist , File Support, GALDERMA

All very good

Carol Walker, Senior Manager , Gilead Sciences

Up-to-date, with practical experience

Barbara Ewald, Regulatory Affairs Manager, Similasan AG

The content was adequate, speakers made it easy to comprehend as well as the presentations were very clear and concise

Chiara Lizio, regulatory affairs manager, NTC

Very good

Emanuela Cagnoni, , NTC S.r.l.