Click here to go to the previous page
Meeting the Therapeutic Needs of Older Patients: A Sustainable Collaborative Approach
Program Code:
340
Date:
Wednesday, June 27, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Head of Global Regulatory Policy in SANOFI R&D, specialised in Internal Medicine and drug development in neurodegenerative diseases. Prior July 2009, Susanna managed the CNS pre-authorisation team at EMA, contributing to the opinion “adequacy of guidance on the elderly” and to the ICH E7 revision.
|
PRESENTER
(S):
Yasuko Asahina, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Luigi Ferrucci, National Institute of Aging, NIH, United States
Yoshiaki Uyama,
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yoshiaki Uyama is currently Director, Regulatory Science Research Division, Office of Regulatory Science, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He leads and coordinates the research of regulatory science in PMDA He is also the leader for PMDA Omics Project (POP).
|
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.
|
Description
Regulators will discuss how to facilitate the implementation of affordable development programs for unmet therapeutic needs of older patients, in line with the existing regulatory guidance for geriatric medicines.
Learning Objectives:
Identify unmet therapeutic needs of older adults
Discuss participation of older adults in clinical trials, issues in geriatric assessment, and regulatory standards for geriatric clinical trials.