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Assessing the Benefits and Risks of Medicines: Webinar Series- Part 7: A Structured, Quantitative Health Outcomes Approach to Drug Benefit-Risk Analysis

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Continuing Education credit or Certificate Program units are not available for Archived Webinars

Benefit-Risk 8-Part Webinar Series Overview

Plan now on participating in this webinar series to learn more about current approaches to Benefit-Risk (B-R) assessment, including how to:

  • Develop an understanding of the current B-R assessment initiatives and requirements
  • Assess how scientific approaches applied in other fields may be employed as an aid to structured and transparent decision analysis in the field of medicinal products
  • Discuss approaches and methods to enhance transparency and communication of B-R decisions
  • Identify opportunities and challenges of implementing exploratory approaches to B-R assessment
  • Identify and discuss processes and methods that may enhance B-R decision making, with the ability to:
    • Engage multiple perspectives
    • Quantify values
    • Evaluate the impact of uncertainty
    • Incorporate preference analysis and measurement
    • Provide greater infrastructure and consistency
    • Increase transparency

Assessing the Benefits and Risks of Medicines: Webinar Series Learning Objectives

  • Describe the current status of B-R assessment and key initiatives
  • Discuss approaches to perform B-R assessment to support and inform decision making
  • Identify uses for B-R assessment, such as regulatory decision-making or communication with patients

Overview Part 7:

Regulatory authorities make difficult benefit-risk decisions when approving new drugs. Food and Drug Administration (FDA) advisory committees and reviewers must consider a complex body of evidence, including efficacy and safety results of trials, disease epidemiology, potential side effects, and patients’ needs. However, this menu of information is not usually presented in a consistent and integrated framework. The members of an FDA review panel vote with some unobserved, implicit weighting of the evidence. This session will discuss how outcomes research tools for modeling long-term health outcomes, measuring health preferences, and establishing the value of additional information could provide a more structured, transparent, and quantitative process of assessing risk-benefit balance.

Archived Webinar Available through July 31, 2014

Who Should Attend 

Professionals involved in:

  • Clinical Safety/Pharmacovigilance
  • Risk Management/REMS
  • Pharmacoepidemiology
  • Regulatory Affairs
  • Legal Affairs
  • Medical Affairs
  • Medical product safety assessment
  • Marketing
  • Clinical Research
  • Medical Communications
  • Statistics
  • Comparative Effectiveness/HTAs/Health Outcomes
  • Brand Commercial Teams


  • Regulators facing complex benefit-risk (B-R) decisions, as well as regulatory and drug development policy makers
  • Industry scientists involved in the evaluation of the B-R assessment of products in development or marketed products
  • Patient representatives and advocates who wish to have greater representation of their needs and concerns in decision making
  • Those wishing to learn more about the science and application of B-R assessment

Learning Objectives 

Learning Objectives Part 7:

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

  • Describe a health outcomes model that assesses drug safety and benefits
  • Discuss how the application and use of quality adjusted life years (QALYs) is a framework for quantifying Benefit-Risk trade-offs for pharmaceuticals

Special Offers 

Series Discount Available!
Register for multiple webinars in the series and save 15%!

Contact Information 

Questions on Archived Webinar
Jessica Culp
DIA North America
Phone +1.215.442.6132
Fax +1.215.442.6199

Technical Requirements 

Click here for minimum system requirements.


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Day 1 Thursday, Jun 13, 2013

  • 7:00AM - 11:59PM

    Assessing the Benefits and Risks of Medicines: Webinar Series- Part 7: A Structured, Quantitative Health Outcomes Approach to Drug Benefit-Risk Analysis

    Session Chair(s):

    • Rebecca A. Noel, DrPH, MPH
      Senior Research Scientist, Global Patient Safety
      Eli Lilly and Company, United States


    • Health Outcomes Modeling for Benefit-Risk Assessment: Introduction
      Louis Garrison, PhD
      Prof and Assoc Dir, Pharmaceutical Outcomes Rsrch & Policy Prog Dept of Pharmacy
      University of Washington, United States
    • Health Outcomes Modeling for Benefit-Risk Assessment: A Case Study in Diabetes
      James Cross, PhD, MS
      Program Director, Product Development Regulatory
      Genentech, Inc., United States

Registration Fees 

Other Fees

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Group Discounts

Series Discount Available:
Save 15% by registering online in one transaction for multiple webinars in this series. (Special pricing valid for online registrations by Industry individuals and groups. Does not apply to already discounted fees.)

No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

Participants with Disabilities Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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