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Using Patient-Reported Outcomes to Assess Product Safety and Tolerability: Methodological and Regulatory Considerations

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Overview 

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


An accurate and comprehensive assessment of safety is critical when establishing the Benefit-risk profile of new medical products. All stakeholders in the health care industry, from regulators to patients, use this information to make decisions regarding the use of new products. The principles underlying the assessment of Patient-reported outcomes (PROs) can be used to quantify the patient's perspective on safety and tolerability and enhance our understanding of a product's benefit-risk profile. This presentation will outline methodological and regulatory considerations when using PROs in this manner and describe applied examples.

In this webinar the presenters will highlight the following:

  • Industry Perspective on Using Patient-reported Outcomes to Assess Safety and Tolerability
  • Scientific Rationale for Using Patient-reported Outcomes to Assess Adverse Events in Clinical Research
  • Regulatory Considerations on Using Patient-reported Outcomes


Archived Webinar Available through May 30, 2014

Who Should Attend 

Professionals involved in:

  • Clinical Operations
  • Clinical Safety and Pharmacovigilance
  • Regulatory Affairs
  • Research & Development/Strategic Issues
  • Quality of Life/Health Economics/Outcomes Research

Learning Objectives 

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

  • Explain the rationale for using PROs to measure drug safety and tolerability
  • Describe methodological and regulatory considerations in using PROs as safety and tolerability measures

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 Monday, May 20, 2013

  • 11:00AM - 11:59PM

    Using Patient-Reported Outcomes to Assess Product Safety and Tolerability: Methodological and Regulatory Issues


    Session Chair(s):

    • Chad Gwaltney, PhD
      Senior Director, Consulting Services
      ERT, United States

    Using Patient-Reported Outcomes to Assess Product Safety and Tolerability: Methodological and Regulatory Issues

    Speaker(s):

    • Industry Perspective on Using Patient-reported Outcomes to Assess Safety and Tolerability
      Ari Gnanasakthy, MBA,MS,MSc
      Head, Patient Reported Outcomes
      Novartis Pharmaceuticals Corporation, United States
    • The Scientific Rationale for Using Patient-reported Outcomes to Assess Adverse Events in Clinical Research
      Ethan Basch, MD,MSc
      Director, Cancer Outcomes Research Program; Associate Professor of Medicine
      University of North Carolina At Chapel Hill, United States
    • Regulatory Considerations on Using Patient Reported Outcomes
      John H. Powers, MD,FACP
      Associate Clinical Professor of Medicine
      George Washington University School of Medicine, United States

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

  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.
  • Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.


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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