The Aging Population: Approaches to Ensure Safety and Efficacy

Track:
Regulatory Affairs and Submissions

Day & Time:
June 25, 10:15AM - 11:45AM

Session Number:
233

Room Number:
253A

Level:
Intermediate

Type:
Forum

Title:
The Aging Population: Approaches to Ensure Safety and Efficacy

Chair(s):
Francesca Cerreta, PharmD,MPharm,MS
Scientific Administrator
European Medicines Agency, European Union, United Kingdom

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.

Learning Objective(s):
Explain the need to meet the challenge of designing clinical studies for an aging population; Discuss regulator’s expectations and explore feasible strategies to acquire and analyze data in comorbid and frail geriatric patients.

Presentation(s) & Speaker(s):
FDA Perspective
Robert J. Temple, MD
Deputy Center Director for Clinical Science, CDER
FDA, United States

Drug Development for Older Population in Japan: Current Status and Challenges
Yasuko Asahina, PhD
Researcher, Office of Regulatory Science
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Industry Point of View
Susanna Del Signore, MD
Associate Vice President, Global Regulatory Affairs
Sanofi, France