Pharmaceutical Regulatory Affairs in Latin America
Explore and gain insights into the regulatory framework of the main authorities in key Latin America countries (Brazil, Mexico, Colombia, Chile, Argentina and Peru).
Pharmaceutical products undergo evaluation based on the regulatory requirements outlined by each country for their sanitary registration. The Latin American region faces significant regulatory challenges due to the absence of a unified and standardized procedure among authorities. Each regulatory body has its own set of regulations, making it daunting to navigate through the diverse legal frameworks. In this course, participants will gain insights into the specific regulations of each country, delve into various approaches to obtaining marketing authorization, and analyse commonalities and differences among the most advanced regulatory authorities in Latin America.
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.
Upcoming start dates
Suitability - Who should attend?
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.
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
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