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Baltimore Marriott Waterfront

05 feb 2024 7:00 a.m. - 07 feb 2024 1:00 p.m.

700 Aliceanna Street , Baltimore, MD 21202

Global Pharmacovigilance and Risk Management Strategies Conference

Register for 2 or more short courses and save $150 off your registration fee!

Session 11: Signal Detection and Evaluation

Session Chair(s)

James  Buchanan, PharmD

James Buchanan, PharmD

President

Covilance LLC, United States

New methods of detecting safety signals are evolving. This session will explore novel ways in which safety signals may be identified within social media postings as well as the use of large language models to detect adverse events within clinical notes from electronic health records. The results from a horizon scan will be summarized concerning the use of AI tools and natural machine learning for safety surveillance in the absence of a REMS as well as the use of real-world data (RWD) by Sentinel for signal detection.

Learning Objective :
  • Understand the application of disproportionate reporting rate algorithms to the evaluation of social media sources of adverse event information
  • Describe how large language models can be applied to detecting adverse events from electronic health information
  • Discuss how Sentinel utilizes real-world data for signal detection
  • Explain how AI and natural machine learning tools can assist in safety surveillance in the absence of a REMS

Speaker(s)

Patrick M. Caubel, MD, PhD, MBA

Social media safety monitoring: Emergence of a new global tool for early signal detection? Experience from the COVID-19 vaccine

Patrick M. Caubel, MD, PhD, MBA

Pfizer Inc, United States

Chief Safety Officer

Vivek  Rudrapatna, MD, PhD

Automated Adverse Event Detection from Electronic Health Records using Large Language Models

Vivek Rudrapatna, MD, PhD

UC San Francisco, United States

Assistant Professor; Co-Director, Center for Real-World Evidence

Ariela G Chick, MPH

A Horizon Scan Perspective on the use of AI and Real-World Data for Signal Detection

Ariela G Chick, MPH

Perspective PV, United States

Senior Strategic PV Advisor

Peg  Fletcher, MD, PhD

Signal Detection for Clinical Trial Design: Finding the Right Questions

Peg Fletcher, MD, PhD

MedAssessment, Inc., United States

President

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