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

May 17 2013 11:00AM - May 17 2013 12:30PM | Online

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Overview 

This webinar will be broadcast in Eastern Daylight Time (EDT)


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

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 

Registration Questions
Marilyn Ginsberg, Customer Service Associate
Phone +1.215.442.6135
Fax +1-215.442.6199
Marilyn.Ginsberg@diahome.org

Agenda and Event Details
Colleen Braun, Content Lead
Phone +1.215.442.6160
Fax +1-215-442-6199
Colleen.Braun@diahome.org

Event Logistics
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1.215.442.6199
Ellen.Diegel@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Continuing Education 

CONTINUING EDUCATION

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102 (703) 506-3275.

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .2 CEUs for this program. Participants must attend the entire webinar in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

DIA’s Certificate Program

This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Safety and Pharmacovigilance Certificate Program: 1 Elective Unit
• Regulatory Affairs Certificate Program: 1 Elective Unit

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Using Patient-Reported Outcomes to Assess Product IACET 1.50 0.200

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must participate in the live webinar, and complete the online credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Friday, May 31, 2013.

Continuing education credits are available to learners who participate in the live webinar.

Continuing education credits and DIA’s certificate program elective units are not available for the archived webinar.

To view DIA’s Grievance Policy, please visit the CE page on the DIA website at www.diahome.org/CE

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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