DIA 2013 49th Annual Meeting
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Navigating the Regulatory Pathway for Advanced Therapy Medicinal Products (ATMPs) and Combined ATMPs
Track
:
Track 08:Regulatory Affairs and Submissions
Program Code:
134
Date:
Monday, June 24, 2013
Time:
2:30 PM to 4:00 PM
EST
Location:
253B
CHAIR
:
Mark J. Hope, (SCHNON), Global Head of Neuroscience and Cardiovascular-Metabolism, Regulatory Affairs, F. Hoffmann-La Roche Ltd., Switzerland
SPEAKER
(S):
Sunita Prem Ahir, PhD,MSc,RAC (SPKNON), Regulatory Affairs Manager, D-Target SA, A Premier Research Company, Switzerland Spiros Vamvakas, MD (SPKAGY), Head of Scientific Advice, Human Medicines Special Areas, European Medicines Agency, European Union, United Kingdom Agnes V. Klein, DrPH,MD (SPKAGY), Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products, Health Canada, Canada
Description
This session will discuss a first analysis and achievements of regulations and legislation for Advanced Therapy Medicinal Products (ATMPs), which are defined as gene therapy and somatic cell therapy medicinal products and tissue-engineered products.
This session is a part of:
This session is a part of: