Overview of the Rules Governing Medicinal Products & Medical Devices
Use of Expert Reports
Drug Master File (DMF) Use in Latin America Registrations
Labeling & Packaging Leaflet Requirements
Processing Variations on Licensed Products
Comparing and Contrasting Latin American Procedures vs. the U.S. FDA
Orphan Drugs / Rare Diseases
The Regulatory Negotiation Process
How and When to Influence the Regulatory Process
Resources / Helpful Websites
How to Use Regulations / Regulatory Contacts to Your Advantage
Who should Attend
Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant
Regulatory personnel whose responsibilities require knowledge of Latin America`s regulatory environment
Global Supply Chain personnel
QA / QC Personnel
Manufacturing personnel
Clinical / Pharma & Device personnel
Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit
Global Business Development personnel
Past Events
Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry 2019 - 21 May 2019, Webinar (37961)
Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry 2026
Important
Please, check "Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry" official website for possible changes, before making any traveling arrangements
