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DIA 2021 Global Annual Meeting


A Journey of Interdisciplinary Collaboration to Improve Safety Evaluation in Drug Development

Session Chair(s)

Mengchun  Li, MD, MPA

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.

Speaker(s)

Barbara  Hendrickson, MD

Aggregated Safety Assessment Planning

Barbara Hendrickson, MD

  • Immunology Therapeutic Area Head, Pharmacovigilance and Patient Safety
  • AbbVie, Inc., United States
Brian  Edwards, DrMed

Benefit-Risk Planning Across the Industry and Best Practice Sharing

Brian Edwards, DrMed

  • Managing Director
  • Husoteria Ltd, United Kingdom
James  Buchanan, PharmD

Interactive Safety Graphics

James Buchanan, PharmD

  • President
  • Covilance LLC, United States
Lothar  Tremmel, PhD

Panelist

Lothar Tremmel, PhD

  • VP, Quantitative Clinical Sciences and Reporting
  • CSL Behring, United States