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MOVING FROM RISK MANAGEMENT TO BENEFIT/RISK MANAGEMENT PLANNING

Track:
Benefit/Risk Management and Lifecycle Approach

Day & Time:
March 27, 11:00AM - 12:30PM (Central European Standard Time)

Session Number:
0306

Room Number:
Room E2

Type:
Session

Title:
MOVING FROM RISK MANAGEMENT TO BENEFIT/RISK MANAGEMENT PLANNING

Chair(s):
Susana Perez-Gutthann, MD, PhD, MPH, FISPE, FRCP
Vice President, Global Head Epidemiology
RTI Health Solutions, Spain

Description:
European pharmacovigilance legislation has driven the integration of benefit and risk evaluations in the approval and post approval lifecycle. This has a profound impact on the planning of risk management activities and safety research in a real world setting. The session will provide a regulatory guidance and recommendations and how this changes planning of the risk management strategy and the study portfolio from an industry and research centre perspective.

Presentation(s) & Speaker(s):
From Risk Management to Benefit/Risk Management Planning: A regulatory perspective
Tomas Salmonson, PhD
CHMP Chair
European Medicines Agency, Sweden

From Risk Management to Benefit/Risk Management Planning: An industry perspective
Noah Jamie Robinson, PhD
Head, Epidemiology, Product Development
F. Hoffmann-La Roche, Switzerland

Incorporating Benefits in Assessments and Epidemiology Studies: A research center perspective
Susana Perez-Gutthann, MD, PhD, MPH, FISPE, FRCP
Vice President, Global Head Epidemiology
RTI Health Solutions, Spain