Dear colleagues,
Please find details below of a one hour-long, educational web tutorial relating to electronic reported outcomes. Four ‘rapid’ talks from chapter authors of a forthcoming book will be given to allow a wide range of topics including statistical design and sample size calculations . The talks will be given from a scientific viewpoint – they will not be Company promotional.
Times are
Tuesday, March 23rd , 2010 – Europe: 3.00 pm UK; 4.00pm CET; 5.00pm EET; US 10:00 am EST
Thursday, March 25th, 2010 – Europe: 6.00pm UK; 7.00pm CET; 8.00pm EET; US 1:00 pm EST
http://www.perceptive.com/News/Webinars/Webinar.html?id=83
If you are interested, please register at the link above - there is no need to reply direct to me, although I am happy to answer any queries on content, timing or registration.
Kind regards
Malcolm
Malcolm Morrissey
Perceptive Informatics
ePRO: Industry Best Practice and Today's Regulatory Considerations
Global use of electronic patient-reported outcomes (ePRO) now exceeds 1,500 clinical trials. Both sponsors and ePRO vendors have extensive expertise in identifying where ePRO is best applied and the associated industry best practice and regulatory considerations.
Two important documents that directly impact the ePRO arena have recently been released: ePRO: Electronic Solutions for Patient Reported Data (edited by Drs. Bill Byrom and Brian Tiplady) and the FDA's final guidance on the use of patient-reported outcomes for labeling claims. This webinar will focus on several important topics discussed in these documents.
During the webinar, industry experts will provide an update on today's most important issues regarding ePRO use in a clinical drug trial. The content is organized in a unique, rapid-fire format and will cover important ePRO topics including: measurement equivalence for ePRO, reducing sample size via ePRO data integrity, migrating clinician instruments to ePRO and user interface design issues for ePRO. The webinar will also include a Q&A session.
Learning Objectives:
Understand the top five ePRO implications of the FDA's final PRO guidance
Learn about effective ePRO measurement equivalence trial designs
Understand sample size considerations and compliance issues when ePRO is being used
Learn about industry best practice for ePRO user interface design and migration of clinician reports to ePRO
Hear from the following experts:
Bill Byrom, Ph.D.
Senior Director, Product Strategy
Perceptive Informatics
Dr. Byrom holds responsibility for providing strategic direction to Perceptive's suite of products including developing new areas of technology application within clinical trials and healthcare. He has worked in a number of roles within statistics, clinical development and international marketing. Bill is the author of over 50 articles and chapters in professional journals and publications.
Brian Tiplady, Ph.D.
Senior Scientific Consultant
PRO Consulting
invivodata
Dr. Tiplady is a trained Neuroscientist and a pioneer in the development of tests for portable platforms, such as handheld PDAs and mobile phones. He is a consultant to the industry for study design and analysis, as well as cognitive test development and deployment.
Damian McEntegart
Senior Director of Statistics and Product Support(includes ePRO)
Perceptive Informatics
Damian leads the group that provides all of Perceptive's specialist support on electronic patient-reported outcomes, randomization and medication management. Damian has worked in the pharmaceutical industry for 25 years, during which time he has published over 40 articles and letters related to these areas.
Keith Wenzel
Senior Product Director, ePRO
Perceptive Informatics
Presently, Mr. Wenzel is responsible for advising clinical trial sponsors and he consults with regulatory authorities and industry organizations to advance the knowledge of electronic patient-reported outcomes (ePRO) and their application in clinical trials. He is a member of the leadership council of ISPOR's ePRO special interest group and also on the core committee for the DIA's Study Endpoints SIAC.
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