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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

William Gregory, PhD

  • Senior Director, Safety and Risk Management
  • Pfizer Inc, United States
Michael  Richardson, MD, FFPM

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)

William  Gregory, PhD

Speaker

William Gregory, PhD

  • Senior Director, Safety and Risk Management
  • Pfizer Inc, United States
Michael  Richardson, MD, FFPM

Speaker

Michael Richardson, MD, FFPM

  • International GPV&E and EU QPPV, Qualified Person for Pharmacovigilance
  • Bristol-Myers Squibb, United Kingdom