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Session 8: Safety Signaling and Evaluation: Practical Considerations and Tools
Session Chair(s)
James Buchanan, PharmD
President
Covilance LLC, United States
Although the term “safety signal” is commonly used, it can be subject to misunderstanding. Safety evaluation encompasses a wide variety of data sources, thus a signal can take many forms. Large amounts of data can be difficult to review; however, data visualization tools can greatly facilitate the process. Having identified a signal, potential sources of confounding and bias need to be considered. There are various approaches to considering evidence supportive of a causal association which collectively can be organized in a framework such as the Hills Criteria of Causation.
Learning Objective : - Appreciate how safety signals may present from individual cases and aggregate data analysis
- Understand how data visualization tools can facilitate the signaling and evaluation process
- Identify instances when the appearance of a signal is due to confounding or bias
- Apply a framework such as the Hills Criteria of Causation when evaluating evidence for and against a causal association with a drug
Speaker(s)
Speaker
James Buchanan, PharmD
Covilance LLC, United States
President
Speaker
Mengchun Li, MD, MPA
Merck & Co., Inc., United States
Senior Director, Clinical Research, Infectious Disease
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