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THINKING BEYOND OLD PHARMACOVIGILANCE BOUNDARIES

Track:
Benefit/Risk Management and Lifecycle Approach

Day & Time:
March 26, 11:00AM - 12:30PM (Central European Standard Time)

Session Number:
0302

Room Number:
Room E2

Type:
Session

Title:
THINKING BEYOND OLD PHARMACOVIGILANCE BOUNDARIES

Chair(s):
John D Ayres, JD, MD
Senior Director, Product Safety Assessments, Global Patient Safety
Eli Lilly & Company Ltd., United States

Description:
The session will explore opportunities where pharmacovigilance scientists might bring their expertise into the drug development design space. Incorporating the voice-of-the-patient into safety study design and identifying benefit/risk attributes early in development will be discussed.

Presentation(s) & Speaker(s):
A Framework and Minimum Dataset for Patient-Reported Outcomes in Adverse Event Reporting (PRO-AEs)
Swapu Banerjee, MD, MBA, MSc, FRCP
Deputy Managing Director
Pope Woodhead & Associates Ltd, United Kingdom

Implementation of a Structured B/R Profile Approach into Drug Development
Isabelle Stoeckert
Head Global Regulatory Affairs Europe
Bayer Pharma AG, Germany

Linking Critical Quality Attributes (CQAs) to the Benefit/Risk Calculus
John D Ayres, JD, MD
Senior Director, Product Safety Assessments, Global Patient Safety
Eli Lilly & Company Ltd., United States