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Marriott Wardman Park Hotel

Jan 27, 2020 7:00 AM - Jan 29, 2020 4:15 PM

2660 Woodley Road, NW, , Washington, DC 20008 , USA

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, FRCP

Michael Richardson, MD, FFPM, FRCP

Senior Vice President, WorldWide Patient Safety

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

Pfizer Inc, United States

Senior Director, Safety and Risk Management

Michael  Richardson, MD, FFPM, FRCP

Speaker

Michael Richardson, MD, FFPM, FRCP

Bristol-Myers Squibb, United Kingdom

Senior Vice President, WorldWide Patient Safety

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