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A Journey of Interdisciplinary Collaboration to Improve Safety Evaluation in Drug Development
Session Chair(s)
Mengchun Li, MD, MPA
Senior Director, Clinical Research, Infectious Disease
Merck & Co., Inc., United States
This session will discuss the outputs from the DIA-ASA joint scientific working group which include an aggregate safety assessment planning tool, benefit risk assessment planning, and open source interactive graphical tools, and how to implement them.
Learning Objective : Describe the importance of multidisciplinary collaboration; Evaluate the aggregate safety assessment planning tool; Discuss the status of benefit risk evaluation planning and how pre-marketing safety monitoring interconnects with benefit-risk evaluation; Identify open source interactive safety graphics tools with pragmatic guidance that can be easily applied to routine safety evaluation.
Speaker(s)
Aggregated Safety Assessment Planning
Barbara Hendrickson, DrMed, MD
United States
Clinical Associate, Pediatric Infectious Diseases
Benefit-Risk Planning Across the Industry and Best Practice Sharing
Brian Edwards, DrMed
International Society of Pharmacovigilance, United Kingdom
Director
Interactive Safety Graphics
James Buchanan, PHARMD
Covilance LLC, United States
President
Panelist
Lothar Tremmel, PHD
CSL Behring, United States
Vice President, Quantitative Clinical Sciences and Reporting