Introduction to Marketing Authorization Regulations in Latin America

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Introduction to Marketing Authorization Regulations in Latin America

In recent years, China has eased its market regulations when it comes to over-the-counter (OTC) medicines, allowing for the importation of OTC products through new channels such as cross-border E-commerce. This comes at a time when consumption of OTC products is growing, as Chinese consumers become more health conscious, providing new opportunities in the category.

However, in order to ensure long-term success, OTC medicine brands need to understand the market, the category, and the consumers. Brands need to develop a market entry plan that considers both the sales channels available and the marketing strategies that will help the brand to reach the target consumers.

During this webinar with Ryan Molloy, CEO of RedFern Digital, we will be discussing the China market entry options for foreign OTC drugs, before diving into aspects ranging from trends in the category and packaging and design, to changes in consumer demographics. We will provide viewers with an understanding of the OTC medicines category in China, along with practical advice and best practices when it comes to branding and marketing.

Introduction to Latin America

- Countries to be covered during the training and general characteristics
- Regulation development in the region: diverse regulations, constant updates
- National Regulatory Authorities (NRA)
- PAHO Reference NRAs
- NRAs in global harmonization initiatives (ICH, ICMRA, PIC/s)

Brazil
Colombia
México
Argentina
Peru

(For each country, a general approach regarding Health Authority, Legal Framework, GMP Certifications, Marketing Authorization, and General Pharmaceutical Evaluation Requirements).

Schedule

Date	Time (GMT +8)	World Clock	Language
2023-03-16	21:00 ~ 22:00	Porto Alegre: 10:00-11:00 Lisbon: 13:00-14:00 London: 13:00-14:00 New York: 9:00-10:00	English

Speaker

Milena Barrozo

Regulatory Affairs Consultant, Co-founder, and Director at Vita Regulatory Affairs Consulting

Milena is based in Brazil. Since 2007 is working in the pharmaceutical industry field such as quality assurance, quality control, and, mainly, regulatory affairs. National and international experience. She has been responsible for the CTD training and pilot projects in several Brazilian Pharmaceutical Industries, as well as training and projects in Europe. Industrial Pharmacist with MBA degree in Business Management; post-graduation in Regulatory Affairs; Personal and Professional Coach; Master\’s degree in Regulation and Evaluation of Medicines and Health Products for Europe.

Alessandra Rolim

Regulatory Affairs Consultant at Vita Regulatory Affairs Consulting

Alessandra is based in Brazil. Since 2004, Alessandra has been working in regulatory affairs, for pharmaceutical and cosmetic industries, in Brazil and other Latin American countries, responsible for marketing authorization and post-approval strategies and processes. She holds degrees as a Pharmacist and is in a specialization course in Business Administration.