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The Aging Population: Approaches to Ensure Safety and Efficacy
Session Chair(s)
Francesca Cerreta, PharmD, MPharm, MS
Principal Scientific Officer
European Medicines Agency, Netherlands
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 : 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.
Speaker(s)
FDA Perspective
Robert J. Temple, MD
FDA, United States
Senior Advisor for Clinical Science, OCD and Immediate Office, OND, CDER
Drug Development for Older Population in Japan: Current Status and Challenges
Yasuko Asahina, PhD
National Center of Neurology and Psychiatry, Japan
Researcher, Clinical Research Support Office, Translational Medical Center
Industry Point of View
Susanna Del Signore
Bluecompanion Ltd, United Kingdom
Director and Founder
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