返回 Agenda
Session 13: Signal Detection
Session Chair(s)
James Buchanan, PharmD
President
Covilance LLC, United States
This session will cover several topics pertaining to the identification and evaluation of safety signals. One presentation will discuss a multimodal data product approach using a knowledge graph (KG) to enhance signal detection. FDA has previously released their FDA Medical Queries (FMQ) concept. Now PhUSE has published a best practices document for the use of adverse event term groupings that will be reviewed. Having then identified a safety signal, an evaluation is conducted to seek evidence supporting a causal relationship. The final presentation will review various methodologies for conducting a causality assessment.
Learning Objective : - Describe how a Knowledge Graph integrates diverse structured and unstructured data sources for signal detection and its role in developing machine learning algorithms
- Understand the PhUSE recommendations for the use of AE term groupings in signal detection
- Assess the various approaches to considering evidence in support of a causal relationship between the drug and an adverse event
Speaker(s)
Speaker
Representative Invited
MedAssessment, Inc., United States
Mutlimodal Safety Data products to enhance Signal Management and Detection
Sameen Desai, MBA, MS
Bristol-Myers Squibb Company, United States
Executive Director, IT Worldwide Patient Safety
Aspects to Consider in Causality Assessment of Safety Signals: Broadening the Thought Process
Tarek Hammad, MD, PhD, MS, MSc, FISPE
Takeda, United States
Vice President, Head of Medical Safety, Marketed Products & Plasma-Derived Thera