EU Regulatory and CMC/Quality Requirements for Advanced Therapy Medicinal Products

is being presented by Dr. Elliot Lawrence, Associate Director of Regulatory Affairs , with ERA Consulting (UK) Ltd. and airs on Tuesday, July 13th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

Advanced therapy medicinal products (ATMPs) are medicinal products for human use based on gene therapy, somatic cell therapy or tissue engineering. They potentially offer new treatments for diseases and injuries of the human body. The European regulatory framework regarding ATMPs has recently changed to help facilitate free movement of ATMPs within the EU and patient access to these products, and also to foster the competitiveness of European pharmaceutical companies in the field.

This audio conference details the relevant EU regulations, regulatory procedures, and guidelines applicable to ATMPs since the changes in legislation. The speaker also discusses how the changes in the regulatory framework impact the development of an ATMP in terms of the CMC/quality requirements.