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DIA 2021 Global Annual Meeting
A Journey of Interdisciplinary Collaboration to Improve Safety Evaluation in Drug Development
Mengchun Li, MD, MPA
- Director, Phamacovigilance
- Global Alliance For TB Drug Development, 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.
Aggregated Safety Assessment Planning
Barbara Hendrickson, MD
- Immunology Therapeutic Area Head, Pharmacovigilance and Patient Safety
- AbbVie, Inc., United States
Benefit-Risk Planning Across the Industry and Best Practice Sharing
Brian Edwards, DrMed
- Managing Director
- Husoteria Ltd, United Kingdom
Interactive Safety Graphics
James Buchanan, PharmD
- Covilance LLC, United States
Lothar Tremmel, PhD
- Vice President, Quantitative Clinical Sciences and Reporting
- CSL Behring, United States