DIA 48th Annual Meeting
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Building the Benefit-risk Toolbox: Is There a Consensus on a Scientifically Acceptable Framework?
Track
:
Track 08: Regulatory Affairs and Submissions
Program Code:
336
Date:
Wednesday, June 27, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Stuart Walker, Centre For Innovation In Regulatory Science (CIRS), United Kingdom
PRESENTER
(S):
Neil McAuslane, Centre For Innovation In Regulatory Science (CIRS), United Kingdom Rebecca Noel, Eli Lilly and Company, United States
Jason Ferla, Therapeutic Goods Administration (TGA), Australia
Description
This session will review the current perspectives from ongoing initiatives to develop benefit-risk methodologies, examine the tool box of methodologies from the regulators and industry perspective, and discuss if stakeholders can agree on a general scientifically accepted framework.
Learning Objectives:
Discuss the current status of the different benefit risk initiatives
Identify the differences and similarities across models/frameworks for benefit-risk assessment of medicines
Illustrate current thinking on developing a structured framework for benefit-risk assessment of medicines.
Learning Objectives:
Discuss the current status of the different benefit risk initiatives
Identify the differences and similarities across models/frameworks for benefit-risk assessment of medicines
Illustrate current thinking on developing a structured framework for benefit-risk assessment of medicines.
This session is a part of:
Handout Online
