PHT Home > 2010 U.S. User Group Meeting: Agenda

Program Agenda

Tuesday, March 16, 2010
Attendees arrive all day
2:00 pm - 5:00 pm Meeting Registration
6:00 pmWelcome Reception and Dinner
Wednesday, March 17, 2010
7:30 am Breakfast
8:30 am Welcome and Opening Remarks

9:15 am Industry Overview

    Phil Lee
    President and CEO
    PHT Corporation
9:45 am New/Expert Users Breakout

    New Users: The Physician's Perspective to PRO collection
    Expert Users: Submitting Evidence to the FDA: Understanding the PRO Dossier
      Emuella Flood
      Principal
      Oxford Outcomes
10:30 am Break
10:45 am Site-Based Subject Data: Using an ePRO Tablet

11:15 amPHT Spotlight and Product Update

11:45 amRealizing the Promise of ePRO and Future Applications

    Steve Raymond
    Founder and Chief Scientific and Quality Officer
    PHT Corporation
12:15 pmLunch - Keynote Presentation: Globalization and Socialization of Clinical Trials

    Kerri Nelen
    Managing Editor
    Applied Clinical Trials Magazine
1:15 pmThe Site Perspective

    Erin Dallas
    Site Coordinator
    The Houston Sleep Center
1:45 pmBreakout Session I
3:00 pmDepart for Networking Activity and Dinner
Thursday, March 18, 2010
7:30 am Breakfast
8:30 amUsing ePRO and EDC

9:00 amBreakout Session II
10:15 amBreak
10:30 amProject Management: Key Components for
a Successful ePRO Study


11:00 amSelection Criteria for PRO and ePRO Trials

    Elisabeth Kurkimilis
    Clinical Operations Manager
    Celgene Corporation
11:30 amBreakout Session III
12:30 pm Final Remarks

1:00 pmLunch
2:00 pmU.S. 2010 User Group Meeting Concludes

Breakout Session Topics

The PHT PRO and ePRO Conference includes a series of interactive breakout sessions where attendees will actively participate in discussions on specialty topics. The topics for the breakout sessions include:

  • Managing the PRO Dossier
  • 6 successful methods used to collect PRO data, and their mixed use within trials
  • FDA and EMEA Guidance Regulations, and their implications
  • Leveraging eClinical Integrations
  • Regulatory Objectives for ePRO Archives
  • The ROI of ePRO
  • Training Programs for Users, Sites and CROs
  • Review of the Successful DCF Process
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