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Session 8, Track C: When Quantity Affects Quality: The Consequences of Overreporting
Session Chair(s)
Marcia Bailey, BSN, MHS, RN
Safety Evaluation and Risk Management Scientific Director, GSK, Canada
Vanessa Zapata
Associate Director, Regional Pharmacovigilance Officer, Merck Canada Inc., Canada
Caroline Croteau, PHD, RPH
Country Safety Lead, Pfizer Canada Inc, Canada
Safety reports are submitted to Health Authorities (HA) based on regulatory requirements. Some HAs however, have taken action to receive only Individual Case Safety Reports (ICSR) that will truly add value to assessing the benefit-risk or safety profile of a product. Receiving large amounts of poor-quality safety information impedes HAs from focusing on safety data that really matters. At what point does quantity affect quality?
Learning Objective : At the conclusion of this session, participants should be able to:- Identify what is considered as high-quality versus poor-quality safety information
- Recognize the impact of ICSR overreporting on the safety profile of a medication
Speaker(s)
Manfred Hauben, MD, MPH
Senior Director Product Safety Surveillance and Reporting, Pfizer , United States
A Systematic Leave In-Leave-out Analysis of the Effect of Solicited Adverse Event Reports on Signal Detection In A Spontaneous Reporting System Database
Wendy Manko-Singer, DO
AVP, Global Clinical Safety & PV-Individual Case Medical Review, MRL, Merck Sharpe & Dohme, LLC, United States
Overview of the United States FDA IND Safety Reporting Requirements (The Final Rule) and its Impacts