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The Aging Population: Approaches to Ensure Safety and Efficacy
Program Code:
233
Date:
Tuesday, June 25, 2013
Time:
10:15 AM to 11:45 AM
EST
CHAIR
:
Francesca Cerreta,
PharmD,MPharm,MS (SCHAGY), Scientific Administrator,
European Medicines Agency, European Union, United Kingdom
After working for industry in laboratory and clinical research, Francesca Cerreta joined the EMA in 1996. She has worked in various capacities, including setting up the parallel scientific advice programme with FDA, and is currently coordinating the geriatric medicines strategy at the Agency.
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SPEAKER
(S):
Robert J. Temple,
MD (SCHAGY), Deputy Center Director for Clinical Science, CDER,
FDA, United States
Dr. Temple is Deputy Center Director for Clinical Science of FDA’s Center for Drug Evaluation and Research and is Acting Director of the Office of Drug Evaluation I, which is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products.
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Yasuko Asahina, PhD (SPKAGY), Reviewer, Office of New Drug II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Susanna Del Signore,
MD (SPKNON), Associate Vice President, Global Regulatory Affairs,
Sanofi, France
Head of Global Regulatory Policy in SANOFI R&D, Internal Medicine and drug development in neurodegenerative diseases. Lead of an IMI project on "physical frailty". Prior July 2009, as head of CNS pre-authorisation team at EMA, contributed to “adequacy of guidance on the elderly” and ICH E7 Q&A.
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Description
People older than 75 are the fastest growing population segment and are major users of medication, and yet are highly underrepresented in clinical trials. FDA, EMA and PMDA representatives will discuss potential innovative therapeutic, research and regulatory approaches.