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Baltimore Marriott Waterfront

05 feb 2024 7:00 a.m. - 07 feb 2024 1:00 p.m.

700 Aliceanna Street , Baltimore, MD 21202

Global Pharmacovigilance and Risk Management Strategies Conference

Register for 2 or more short courses and save $150 off your registration fee!

Session 7: Insights on Benefit-Risk Assessment

Session Chair(s)

Mengchun  Li, MD, MPA

Mengchun Li, MD, MPA

Senior Director, Clinical Research, Infectious Disease

Merck & Co., Inc., United States

Jeremy  Jokinen, PhD, MS

Jeremy Jokinen, PhD, MS

Vice President and Head, Safety Evidence and Sciences

Bristol-Myers Squibb Company, United States

The CIOMS WG XII Benefit-Risk report was released, outlining the benefit-risk (BR) landscape and promoting the use of a structured BR framework (SBRF) from the beginning and continuously updated and applied throughout the product lifecycle, including key decision-making steps. This will enable a shift from evaluating BR from unstructured ways towards a more structured, transparent multi-stakeholder approach. Also, it advocated for including patient-centric endpoints that capture both benefit and risk in clinical trial designs. Members from CIOMS WG XII will provide an overview of this document, and panelists will be invited to share insights from different perspectives.

Learning Objective :
  • Describe the key recommendations from the CIOMS WG XII Benefit-Risk report
  • Recognize the gaps between the current practice and the recommendations from the CIOMS WG XII Benefit-Risk report
  • Prepare to implement relevant components from the CIOMS WG XII Benefit-Risk report in day job
  • Deploy a multi-functional team for structured benefit risk assessment
  • Initiate internal conversations to facilitate incorporating patient input to inform SBRF

Speaker(s)

Hong  Yang, PhD

CIOMS Working Group (WG) XII Report: Overview and Chapter II-Structured BR Approach/Framework

Hong Yang, PhD

FDA, United States

Biologist, OBPV, CBER

Richard  Forshee, PhD

CIOMS Working Group (WG) XII Report: Chapter III-BR Methodology Considerations

Richard Forshee, PhD

FDA, United States

Deputy Director, OBPV CBER

Susan  Colilla, PhD, MPH

Speakers

Susan Colilla, PhD, MPH

Teva Pharmaceuticals, United States

Epidemiology Leader

Brian  Edwards, DrMed

Panelist

Brian Edwards, DrMed

International Society of Pharmacovigilance, United Kingdom

Vice President

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