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Assessing the Benefits and Risks of Medicines: Webinar Series Part 2 - Benefit-Risk Assessment a Changing Regulatory Landscape

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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 2:

In this webinar presenters will discuss the approaches to structured Benefit-Risk assessment being developed, implemented, and evaluated by the FDA, EMA, CIRS and the Innovative Medicines Initiative.  They will also discuss the new legal requirements for Benefit-Risk assessment embedded in the EU GVP legislation.


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

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 2:

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

  • Discuss the evolving regulatory environment and the emerging expectations for Benefit-Risk assessment
  • Describe the developing approaches to Benefit-Risk assessment in use by FDA, the EMA and industry

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
Jessica.Culp@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Agenda  

Day 1 Thursday, Jan 31, 2013

  • 7:00AM - 11:59PM

    Assessing the Benefits and Risks of Medicines Webinar Series Part 2: A Changing Regulatory Landscape


    Session Chair(s):

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

    Assessing the Benefits and Risks of Medicines Webinar Series Part 2: A Changing Regulatory Landscape

    Speaker(s):

    • Benefit-Risk Assessments at the Center for Devices in the FDA
      Telba Irony, PhD
      Chief, Biostatistics: General Surgical Devices Branch, CDRH
      FDA, United States
    • Modernizing the Drug Regulatory Landscape in Canada to Benefit Patients: An Update on Benefit-Harm-Uncertainty Frameworks and Instruments
      Robyn R. Lim, PhD
      Senior Science Advisor, Office of Legislative and Regulatory Modernization, HPFB
      Health Canada, Canada

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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