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Global Regulation of Advanced Therapies
Session Chair(s)
Gopalan Narayanan, MD, FFPM, FRCP
Vice President, Disruptive Biologics, Voisin Consulting Life Sciences, United Kingdom
Advanced Therapies offer ground-breaking treatment for many diseases that could not be treated previously. Recently, treatments for conditions such as prostate cancer and cartilage regeneration have been approved in the EU. These innovative products are regulated differently by health authorities across the globe. Is it a biologic, a drug, a device, or a combination product? This session will examine the regulatory requirements and classification issues specific to these types of products.
Learning Objective : Identify the regulations and guidance with respect to advanced therapies;Discuss precedent and classification issues for various markets in the development, review and approval of advanced therapy products.
Speaker(s)
Regulatory Perspective
Paula Salmikangas, PhD
Advisory Board, Director of Biopharmaceuticals and ATMPs, NDA Group, United Kingdom
Industry Perspective
Michael Halpin, MS
Vice President, Regulatory Affairs, Genzyme Corporation, A Sanofi Company, United States
Cell and Gene Therapies: How to Engage with EU Regulators
Gopalan Narayanan, MD, FFPM, FRCP
Vice President, Disruptive Biologics, Voisin Consulting Life Sciences, United Kingdom
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