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DIA/FDA Biostatistics Industry and Regulator Forum

This event is now offered in a new entirely virtual format.

Session 6: Safety and Benefit-Risk Assessment

Session Chair(s)

William  Wang, PhD

William Wang, PhD

  • Executive Director, Clinical Safety Statistics, BARDS
  • Merck Research Laboratories, United States
Brenda  Crowe, PhD

Brenda Crowe, PhD

  • Senior Research Advisor, Global Statistical Sciences
  • Eli Lilly and Company, United States
Gregory  Levin, PhD

Gregory Levin, PhD

  • Deputy Director, DBIII, OB, OTS, CDER
  • FDA, United States
Several documents, such as the International Conference on Harmonization (ICH) M4E (R2) and ICH E2 series give guidance on what should be included in safety and benefit risk assessments for new drug applications and post marketing evaluation. These documents set good objectives for safety and benefit-risk evaluation during drug development. How to achieve these goals is an active topic of discussion for regulators and drug developers. This session will focus on the current regulatory landscape, industry practice and emerging trends for safety and benefit risk evaluation throughout the drug development life cycle, with a particular focus on improved planning.
Learning Objective :

At the conclusion of this session, participants should be able to:

  • Discuss FDA’s benefit-risk initiatives
  • Identify ways that safety and benefit-risk planning can be improved
  • Describe key features of program-wide safety and benefit-risk evaluation planning


Sara L. Eggers, PhD

Benefit-Risk Assessment Along the Product Lifecycle

Sara L. Eggers, PhD

  • Director, Decision Support and Analysis Team
  • FDA, United States
Gregory  Levin, PhD

Improved Safety and Benefit-Risk Planning

Gregory Levin, PhD

  • Deputy Director, DBIII, OB, OTS, CDER
  • FDA, United States
Lothar  Tremmel, PhD

Aggregate Safety and Benefit-Risk Assessment Planning: Multi-Disciplinary Approach

Lothar Tremmel, PhD

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

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Additional Information

Biostatistics Industry Resource Kit