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Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)
Presented By ComplianceOnline
Wednesday, October 6th at 11:00am EST
Online sale ends: 10/06/21 at 10:00am EST
online event
6201 America Center Drive Suite 240 San Jose, CA 95002, USA
San Jose, CA 95002
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Description
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.



Presented By

11:00am to 5:00pm
Doors open at 11:00am

General Admission: $999.00

Age
All Ages

online event<br> 6201 America Center Drive Suite 240 San Jose, CA 95002, USA<br> San Jose, 95002

18887172436

conference

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