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Navigating the Regulatory Pathway for Advanced Therapy Medicinal Products (ATMPs) and Combined ATMPs
Session Chair(s)
Mark Hope
Chief Development and Regulatory Officer
Leal Tx, United States
Clinical Trials: The Regulatory Requirements for Combined Advanced Therapy Medicinal Products
Learning Objective : Discuss the status of the implementation of the EU Regulation in the EU; Describe the main challenges of a regulatory framework that is fitted for developers of Advanced Therapy Medicinal Products; Identify some of the key issues when approving a stem cell product.
Speaker(s)
Clinical Trials: The Regulatory Requirements for Combined Advanced Therapy Medicinal Products
Sunita Prem Ahir, PhD, MSc, RAC
Independent, Switzerland
Consultant
Preapproval Advice: How Can EMA Support and Recent Experience with the Regulation for Advanced Therapy Medicinal Products
Spiros Vamvakas, MD
European Medicines Agency, Netherlands
Scientific Advior on Human Medicines
Current Status of Cell Therapies From a Regulatory Perspective
Agnes Klein, MD
Health Canada, Canada
Senior Medical Advisor
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