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Ottawa Conference and Event Centre

2023年11月07日 (火) 午前 7:30 - 2023年11月08日 (水) 午後 4:10

200 Coventry Road, Ottawa, ON K1K 4S3, Canada

Canada Annual Meeting

The Canada Annual Meeting offers Three Tracks, Regulatory, Clinical, Pharmacovigilance!

Session 8, Track C: When Quantity Affects Quality: The Consequences of Overreporting

Session Chair(s)

Marcia  Bailey, BSN, MHS, RN

Marcia Bailey, BSN, MHS, RN

Safety Evaluation and Risk Management Scientific Director

GSK, Canada

Vanessa  Zapata

Vanessa Zapata

Associate Director, Regional Pharmacovigilance Officer

Merck Canada Inc., Canada

Caroline  Croteau, PhD, RPh

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

A Systematic Leave In-Leave-out Analysis of the Effect of Solicited Adverse Event Reports on Signal Detection In A Spontaneous Reporting System Database

Manfred Hauben, MD, MPH

Pfizer , United States

Senior Director Product Safety Surveillance and Reporting

Wendy  Manko-Singer, DO

Overview of the United States FDA IND Safety Reporting Requirements (The Final Rule) and its Impacts

Wendy Manko-Singer, DO

Merck Sharpe & Dohme, LLC, United States

AVP, Global Clinical Safety & PV-Individual Case Medical Review, MRL

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