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Dear Colleagues,
Please find details below of a free, one hour long educational web tutorial
relating to Patient Reported Outcomes including Quality of Life scales.
The presentations will focus on recent regulatory developments and their
implications for use of PRO/Qol measures in pharma trials. The presentations
will be given from a scientific viewpoint and will not be Company
promotional. Pros and cons of different implementation solutions will be
discussed.
PRO Regulations – Putting Theory into Practical Application
Adam Wood (ClinPhone ePRO Solutions Manager) Keith Wenzel (ClinPhone ePRO
Product Director)
04 Oct 2006: 3.00 pm UK Time, 4.00 pm CET, 5.00pm EET, 10.00am US East
Coast Time
05 Oct 2006: 7.00 pm UK Time, 8.00 pm CET, 9.00pm EET, 2.00pm US East
Coast Time
Visit www.clinphone.com/webinars to review full agenda (also reproduced
below) and register today!
If you are interested, please register at the link above.
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PRO Regulations – Putting Theory into Practical Application
Agenda
The FDA’s draft Guidance for Industry on Patient Reported Outcome Measures
has stimulated a great deal of discussion in biopharma. While the Guidance
clarifies many vital issues for the use of PRO instruments, delivered on
paper or electronically, several sections have raised additional questions.
Many sponsors are actively seeking practical ways to proceed with the use of
PROs and ePRO. Key questions include:
What are the key requirements of the Guidance with respect to ePRO?
When must I prove the validity of the ePRO instruments I am using?
What alternatives are available for ePRO validation?
How can I increase the odds that my ePRO data will be accepted by the FDA?
This webinar will explore the key principles of the draft Guidance and will
also present the European perspective based on EMEA’s regulations. More
importantly, the session will discuss how to apply the theoretical
requirements pragmatically in real world clinical trials.
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