RA306 International Regulatory Submissions (except U.S., Canada, Europe)

This course provides an insight to the International Pharmaceutical and Biologics Regulations. It is designed to provide an overview of the regulatory and lifecycle management requirements for drugs and biologics in Latin America, Asia-Pacific Region as well as Middle East and Africa. Students will learn about the international regulatory framework for prescription and non-prescription drugs and biologics such as pre-marketing and post-marketing requirements, labeling, advertisement and promotion as well as international pharmacovigilance practices.

Learning Points:

• Overview of Global Pharmaceutical Structures
• Dossier Formats Across the Globe
• Drug Pre-Marketing and Authorization Requirements
• International Market for Generics and Biosimilars
• Patents and Exclusivity
• International Advertising and Promotion
• Regulatory Strategy