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Monday, June 20 • 4:00pm - 5:00pm
#132: ICH E2D Update: Innovations in Collecting Safety Data from Disparate Sources

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-525-L04-P ; CME 1.00; RN 1.00

This session will discuss how this document aims to establish an internationally standardized procedure to improve the quality of post-approval safety information and to harmonise the way of gathering and reporting information. It provides guidance on definitions and standards for post-approval expedited reporting, as well as good case management practices.

Learning Objectives

Describe an international standardized procedure to improve the quality of post-approval safety information; Discuss guidance on definitions and standards for post-approval expedited reporting.


Vicki Edwards, RPh


Industry Update
Michelle Grimes, MSc

Industry Update
David John Lewis, PhD

FDA Update
Robert Ball, MD, MPH, MSc

FDA Update
Craig Zinderman, MD, MPH

avatar for Robert Ball

Robert Ball

Deputy Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug and biologic product safety and effectiveness using Real World... Read More →
avatar for Vicki Edwards

Vicki Edwards

Vice President, Pharmacovigilance Excellence and International QPPV, AbbVie, Inc., United Kingdom
Qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. On her return to the UK, Vicki spent the next four years in community... Read More →
avatar for Michelle Grimes

Michelle Grimes

Head, International Pharmacovigilance. GCS&PV, Merck and Co., Inc., Denmark
Michelle is leading the International Pharmacovigilance organization at Merck. She has 25+ years of experience in the pharma industry and worked in clinical research and consulting prior to moving into pharmacovigilance (PV). Since joining Merck in 2002 she has performed various roles... Read More →
avatar for David Lewis

David Lewis

Head QPPV PRRC Office, Chief Medical Office & Patient Safety, Novartis Pharma AG, Switzerland
Dr Dave Lewis joined Novartis in March 2007 following 20 years’ pharmacovigilance at GSK and at Shire. He has worked in country affiliates and in a variety of global safety & risk management functions with both investigational & marketed products, as well as in roles involving systems... Read More →

Craig Zinderman

Associate Director for Medical Policy, Office of Biostatistics and Pharmacovigil, FDA, United States
Dr. Zinderman has worked in the Division of Epidemiology in the Office of Biostatistics and Pharmacovigilance (OBPV) since 2004. He initially served as a Medical Officer and Epidemiologist in the Therapeutics and Blood Safety Branch for 4 years, before becoming the Acting Branch Chief... Read More →

Monday June 20, 2022 4:00pm - 5:00pm CDT
Room 175 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  01: ClinSafety-PV, Session |   09: Regulatory, Session