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Pharmaceutical Regulatory Affairs in Latin America Training Course

Unlock Latin America's Regulatory Landscape: Elevate your Expertise and Explore the Regulatory Framework of the Main Authorities in Latin America (AR, BR, CL, CO, MX & PE)

This programme offers a detailed examination of the regulatory landscape, emphasizing both challenges and opportunities for the pharmaceutical industry across key Latin American markets, including Argentina, Brazil, Chile, Colombia, Mexico, and Peru.

22 October 2024
+ 25 February 2025 »

from £549

Need help?  Enrol or reserve

Course overview

Explore and gain insights into the regulatory framework of the main authorities in key Latin America countries (Brazil, Mexico, Colombia, Chile, Argentina and Peru), crucial for navigating market entry requirements, ensuring compliance with local regulations, and managing pharmaceutical registrations across diverse markets.

Navigating the complex landscape of pharmaceutical regulatory requirements in Latin America is essential for ensuring successful market access and compliance. Unlike regions with standardized procedures, Latin America presents significant challenges due to the diverse and country-specific regulations governing sanitary registration. Each regulatory authority has its own set of rules, creating a formidable task for professionals seeking to bring pharmaceutical products to market.

This course is designed to address these challenges by providing participants with comprehensive insights into the regulatory frameworks of key Latin American countries. Participants will explore various approaches to obtaining marketing authorization and analyse the commonalities and differences among the region's most advanced regulatory authorities.

Throughout the training, participants will engage in in-depth case studies to explore options and strategies for fulfilling crucial regulatory activities. This interactive learning experience will provide opportunities to discuss and exchange experiences with our expert trainer and fellow delegates.

Key topics to be addressed:

  • Pharmaceutical regulations in Latin America covering the following countries: Brazil, Mexico, Colombia, Argentina and Peru
  • Regulatory strategies to grant the registrations and access to Latin America markets.
  • Good interactions practices with Health Authorities of Latin America region
  • Registrations procedures, renewals, and variations in all mentioned countries
  • GMP inspections and stability studies

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

Benefits of attending

  • Explore Latin America's regulatory landscape, registration processes, and recognition mechanisms.
  • Understand varied pathways and strategies dictated by legislation based on the Certificate of Pharmaceutical Product and its compliance criteria.
  • Gain insight into legislation regarding products demonstrating Therapeutic Equivalence, strategy design based on experience, and regulatory intelligence.
  • Compare registration dossier structures covering legal, chemical/pharmaceutical, and clinical aspects.
  • Utilise practical examples to formulate strategies with regulatory authorities.

Who should attend?

This seminar is especially valuable for professionals seeking to master the intricacies of successful marketing authorization applications and in-market regulatory compliance in the Latin American region. Whether you are new to this field or looking to refresh your knowledge, this seminar will provide essential insights and practical guidance.

  • Regulatory Affairs Professionals
  • Research and Development 
  • Project Management
  • Business Planning
  • Business Management
  • Manufacturers
  • Quality Assurance/Quality Control
  • Labelling and Artwork
  • Pharmacovigilance

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This course will cover:

Latin America regulatory environment: legal basis

Key regulations, directives and guidelines

Impact and influence of the main regulatory authorities in Latin America

  • Argentina
  • Brazil
  • Chile 
  • Cuba
  • Colombia
  • Mexico

Harmonisation initiatives within Latin America

Adoption of the Common Technical Document

Drug development: Argentina, Brazil, Chile, Cuba, Colombia & Mexico

  • Regulatory authorities
  • Regulations and regulatory considerations

Marketing authorisation: Argentina, Brazil, Chile, Cuba, Colombia & Mexico

  • Regulations, requirements and regulatory intelligence-based strategy 
  • Registration and certification/legalisation samples

Compilation of dossiers: Argentina, Brazil, Chile, Cuba, Colombia & Mexico

  • Contents and formats
  • Tips for success/failure
  • Country-specific requirements 

Compilation of dossiers: Argentina, Brazil, Chile, Cuba, Colombia & Mexico (continued)

  • Regulatory authority/agency assessment 
  • Process 
  • Deadlines

Regulatory submission strategy: Argentina, Brazil, Chile, Cuba, Colombia & Mexico

  • How to determine an appropriate submission strategy
  • A practical approach - case studies

Commercial structure: Argentina, Brazil, Chile, Cuba, Colombia & Mexico

  • Registration of companies and products
  • Regulation and guidelines

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Belkys Ruiz

Pharmaceutical Chemist graduated from Universidad Central de Venezuela, with more than 15 years of experience in the Pharmaceutical Industry and solid knowledge in the life cycle of medicines. Proficient in the different categories and types of products (new, innovative, generic and specific), medical devices, cosmetics including research, development, authorization and commercialization.  I have a postgraduate degree in Drug Health Surveillance, and I play a strategic role in the area of regulatory affairs, leading teams and building links with the health authority in national and international companies in different countries (both Latin American and European region).

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

22 October 2024

Live online

09:00-17:30 UK (London) (UTC+01)
10:00-18:30 Paris (UTC+02)
04:00-12:30 New York (UTC-04)
Course code 15178

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 17 Sep

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Not ready to book yet?

for 7 days, no obligation

25 February 2025

Live online

09:00-17:30 UK (London) (UTC+00)
10:00-18:30 Paris (UTC+01)
04:00-12:30 New York (UTC-05)
Course code 15179

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 21 Jan

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Colombia

  • Chiesi

Greece

  • Pharmathen

Ireland

  • Amryt Pharmaceuticals DAC,

Norway

  • PHARMAQ

Enrol or reserve

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy