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Assessing the Benefits and Risks of Medicines: Webinar Series - Part 3: Framing for Benefit-Risk Assessment and Communication

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Overview 

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 3:

In this webinar presenters will discuss the importance and critical elements of framing in Benefit-Risk, specifically: disease state, population of interest, value perspective and context.  Presenters will also discuss how these framing elements lend structure and definition to Benefit-Risk discussions, assessments and interpretations.


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

Additionally:

  • 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 3:

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

  • Explain the four fundamental framing elements: disease state, population, reference point and context
  • Describe why all Benefit-Risk assessments are dependent upon and driven by the frame
  • Explain why different frames will yield different Benefit-Risk assessments

Special Offers 

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

Contact Information 

Questions on Archived Webinars
Carolyn Callahan
DIA North America
Phone +1.215.442.6194
Fax +1.215.442.6199
Carolyn.Callahan@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Agenda  

Day 1 Thursday, Feb 28, 2013

  • 7:00AM - 11:59AM

    Assessing the Benefits and Risks of Medicines: Webinar Series - Part 3: Framing for Benefit-Risk Assessment and Communication


    Session Chair(s):

    • No-image Marilyn A. Metcalf, PhD
      Senior Director, Benefit-Risk Evaluation
      GlaxoSmithKline, United States

    Speaker(s):

    • Framing for Benefit-Risk Assessment and Communication
      James Felli, PhD
      Research Advisor
      Eli Lilly and Company, United States
    • Conny Berlin, MS
      Global Head, Quantitative Safety Function
      Novartis Pharma AG, Switzerland

Registration Fees 

Other Fees

Government (Full Time) Individual
$125.00
Charitable Nonprofit/Academia Individual
$175.00
Group Site
$799.00
Group Plus
$995.00

Member

Member Individual
$250.00

Non-Member

NonMember Individual
$295.00
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.)

CANCELLATIONS
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.

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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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