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Tutorial: Making Better Benefit-Risk Decisions through the Development Life Cycle

Feb 9 2014 1:00PM - Feb 9 2014 5:00PM | Hyatt Regency Bethesda One Bethesda Metro Center 7400 Wisconsin Avenue Bethesda, MD 20814-5326

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Tutorial Registration: 12:00 to 1:00 PM 

Understanding how to integrate pharmaceutical Benefit-risk processes and methodologies into a coherent whole has become a vital skill for stakeholders. This tutorial will follow the progression of vignettes at three points in the development and post-approval life cycle, showing how a team might utilize various methodologies in context.
(i) Development: As a team locks its assessment content in place, considers what endpoints to use and roughs out an approach for the assessment when only phase 2 data is available
(ii) Peri-approval: As a team uses all data developed during its clinical program to develop Benefit-risk arguments to use in health authority submissions and advisory committee presentations.
(iii) Post-approval in preparation for a PBRER: Using post-approval data sources, developing and presenting an integrated Benefit-risk assessment.

 Learning Objectives

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

  • Describe how to integrate pharmaceutical Benefit-risk processes and methodologies into a coherent whole
  • Recognize and gain familiarity with the utility from different methods for Benefit-risk assessment at different points in the development life cycle

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Contact Information 

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00 ET

Agenda Details
Jessica McGrory
Phone +1.215.442.6182
Fax +1.215.442.6199

Event Logistics

Benjamin Zaitz, Event Planner

Phone +

Fax +1.215.442.6199



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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.

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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