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Virtual Event

27 may 2020 10:45 a.m. - 29 may 2020 3:30 p.m.

(US Eastern Standard Time)

Fort Washington, PA 19034

DIA/FDA Biostatistics Industry and Regulator Forum

Session 6: Safety and Benefit-Risk Assessment

Session Chair(s)

William  Wang, PhD

William Wang, PhD

President

Merck & Co, Inc, United States

Brenda  Crowe, PhD

Brenda Crowe, PhD

Associate Vice President, Statistics

Eli Lilly and Company, United States

Gregory  Levin, PhD

Gregory Levin, PhD

Associate Director for Statistical Science and Policy, 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

Speaker(s)

Sara L. Eggers, PhD

Benefit-Risk Assessment Along the Product Lifecycle

Sara L. Eggers, PhD

FDA, United States

Director, Decision Support and Analysis Team, OSP, CDER

Gregory  Levin, PhD

Improved Safety and Benefit-Risk Planning

Gregory Levin, PhD

FDA, United States

Associate Director for Statistical Science and Policy, OB, OTS, CDER

Lothar  Tremmel, PhD

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

Lothar Tremmel, PhD

CSL Behring, United States

Vice President, Quantitative Clinical Sciences and Reporting

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