The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, IVDs, Biologics, Biosimilars, Orphan Drugs and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. Other countries such as Chile, Costa Rica, Dominican Republic, Panama, Peru and Venezuela will be discussed. The course will cover topics relating to full product life-cycle management, as well as, address the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
The current regulatory climate in Latin America is discussed in detail and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms in the region are outlined. Course content will explain how Latin America interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. Additionally, participants will learn how personnel can best address the conflicts, which arise and the best course for resolution.
This course will be beneficial to:
April 22, 2021 (11:00 AM TO 5:00 PM EDT)
Eliana Silva de Moraes is a Lawyer, specializing in Public Health Law (1992), graduated in Public Health Law, by Public Health School - University of Sao Paulo (1995); master degree (II) in Biomedical Law University of Coimbra, Portugal (2005), Ph.D. in European Regulatory on Public Health Law by Paris VIII University. 26 years’ experience in Pharmaceutical law, Food law, Cosmetic law, Medical Device and Equipment law, Pharmaceutical and Veterinary product for Brazil and Latin America countries, for administrative, litigation and facilitator process.
Played an active role in setting up Brazil’s Public Health Regulator (ANVISA), organizing the agenda of its first President in USA in order to explore the US System established through the Food and Drug Administration (FDA) in December 1998 as well as in the global harmonization process.