Audience: For scientists, regulatory affairs managers, and other persons interested in learning about regulatory affairs principles, the development and marketing authorisation of Advanced Therapy Medicinal Products (ATMPs) in the EU.

Aims: This webinar is an introduction to relevant categories of regulatory documents and regulatory Agencies in the EU including the European Medicines Agency (EMA) with its committees (especially the CAT). It provides an overview of regulatory framework, definitions and examples for ATMPs and related products. Options how to communicate and discuss questions with the regulatory agencies as well specific ATMP procedures are presented.

Content:
• Understanding the regulatory framework for ATMPs and related products
• Definitions and examples for ATMPs
• Presentation of regulatory EU agencies incl. EMA and important EMA committees (CAT, CHMP and others) and how they connect to each other
• Innovation Task Force Meeting, National Advice and EMA Scientific Advice - communicate with the Agency!
• CAT Classification, Certification for ATMPs – further options for your development By Pharmalex

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