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Pharmacovigilance and Risk Management Strategies Conference
Session 2: What's New at ICH and CIOMS?
Session Chair(s)
William Gregory, PhD
- Senior Director, Safety and Risk Management
- Pfizer Inc, United States
Michael Richardson, MD, FFPM
- International GPV&E and EU QPPV, Qualified Person for Pharmacovigilance
- Bristol-Myers Squibb, United Kingdom
This session will include descriptions of new pharmacovigilance projects being undertaken by ICH and CIOMS including Selective Safety Data Collection, Patient Engagement, MedDRA Term Groupings, and Post-Marketing Safety Data Collection.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe the overall approach to safety data collection being considered by the ICH E19 EWG
- Outline the key objectives of the CIOMS WG 11 Patient Engagement work group
- Describe potential value of principles for MedDRA Term Groupings in Reference Safety Information
- Understand why a revision to the ICH E2D guideline is needed
Speaker(s)
Speaker
William Gregory, PhD
- Senior Director, Safety and Risk Management
- Pfizer Inc, United States
Speaker
Michael Richardson, MD, FFPM
- International GPV&E and EU QPPV, Qualified Person for Pharmacovigilance
- Bristol-Myers Squibb, United Kingdom
Contact us
Registration Questions?
Preconference Short Courses
Short Course 1: Pharmacovigilance and Risk Management Planning
Short Course 2: Interdisciplinary Safety Evaluation During Product Development
Short Course 3: Reference Safety Information
Short Course 4: Introduction to Statistics in Pharmacovigilance
Short Course 5: Pharmacovigilance for Medication Errors
On Demand Content Preview Webinar
Preparing for PV Inspections – Beyond the Basics
Download eBook
Pharmacovigilance and Risk Management in 2020: A Global Perspective