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DEVELOPING MEDICINAL PRODUCTS FOR OLDER PEOPLE –GETTING ON TRACK

Track:
Special Populations

Day & Time:
March 26, 2:00PM - 3:30PM (Central European Standard Time)

Session Number:
0403

Room Number:
Room H

Level:
Intermediate

Type:
Session

Title:
DEVELOPING MEDICINAL PRODUCTS FOR OLDER PEOPLE –GETTING ON TRACK

Chair(s):
Markku Toivonen, MD, PhD
NDA Advisory Board - Scientific Director
NDA Group, United Kingdom

Description:
Rational pharmacotherapy in the older population requires fit-for-purpose data for benefit-risk assessment at the time of marketing application. Specific, early attention is required in designing clinical programs and in providing regulatory input.

Learning Objective(s):
Describe how European regulatory authorities are addressing specific issues in developing medicinal products for use in older people Identify ways to optimise collection of data in older people in pre-marketing phase Recognize specific challenges in benefit-risk assessment of medicinal products for use in older people

Presentation(s) & Speaker(s):
EMA Geriatric Strategy – what is it and how is it delivering?
Jordi Llinares Garcia, DrMed, MSc
Head of Product Development Scientific Support Department
European Medicines Agency, European Union, United Kingdom

Optimising Clinical Trial Design and Conduct to Support Benefit/Risk Assessment in Older Patients
Florian von Raison, DrMed
Senior Global Program Head and Chairman Geriatric Medicine Working Party/ EFGCP
Novartis Pharma AG, Switzerland

Benefit/Risk Assessment in Older Patients in the Pre- and Post-Authorisation
Andrea Laslop, MD
Head of Scientific Office
AGES, Austria