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Assessing the Benefits and Risks of Medicines: Webinar Series - Part 4: Clinical Judgment and Pragmatic Considerations for Endpoint Selection and Display in Benefit-Risk

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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 4:

While there are numerous approaches for drug Benefit-Risk assessment, most share the need for a structured approach to select the endpoints included in the assessment. The requirements for endpoints in Benefit-Risk are not always considered when designing clinical trials and post-marketing studies, and in some cases the requirements may not align with those for the trial/study.  Different approaches for choosing the endpoints for Benefit-Risk vary in their: 

  • Ease of interpretation (including whether an endpoint is a benefit or a risk)
  • Potential for double-counting
  • Mixing of events with varying clinical impact
  • Ability to show core tradeoffs 

In some cases, certain choices can greatly simplify the assessment, even when there is a wide range in the clinical impact of the relevant events.  This webinar will compare and provide pragmatic examples of these approaches for setting up and displaying results of a Benefit-Risk assessment.

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 4:

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

  • Identify conditions when prespecified efficacy and safety endpoints are not the best choice for Benefit-Risk assessment
  • Recognize different means to select endpoints for Benefit-Risk assessment and tradeoffs in their ease of interpretation and use for decisions
  • Recognize different means to display and communicate Benefit-Risk assessment results

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, Mar 21, 2013

  • 7:00AM - 11:59PM

    Assessing the Benefits and Risks of Medicines: Webinar Series - Part 4: Clinical Judgment and Pragmatic Considerations for Endpoint Selection and Display in Benefit-Risk

    Session Chair(s):

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


    • Clinical Judgment and Pragmatic Considerations for Endpoint Selection and Display in Benefit-Risk
      Bennett Levitan, MD, PhD
      Director, Department of Epidemiology
      Janssen Research & Development, United States
    • Other Important Considerations for Choosing and Displaying Benefit and Risk Endpoints
      Richard Hermann, MD, MPH
      Safety Science Physician, Global Patient Safety
      AstraZeneca, United States

Registration Fees 

Other Fees

Government (Full Time) Individual
Charitable Nonprofit/Academia Individual
Group Site
Group Plus


Member Individual


NonMember Individual
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
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