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Companion Diagnostics: Current and Future Developments
Program Code:
112
Date:
Monday, June 25, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Paul Van Dongen, NautaDutilh N.V., Netherlands
PRESENTER
(S):
Paul Van Dongen, NautaDutilh N.V., Netherlands
Stuart is a Regulatory Affairs Certified professional whose current interests include personalized medicine and drug-diagnostic co-development. He co-authored the original RAPS Online Training Course, “Regulation of IVDs” and has authored numerous scientific publications.
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Mr. Sall is a Principal Consultant with PAREXEL Consulting in Waltham, MA. His areas of responsibility include strategic regulatory consulting involving medical devices and combination products.
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Description
Companion diagnostics, in vitro diagnostics that accompany treatments, are a major development in personalized medicine. This session looks into the regulatory and scientific aspects of this innovative approach.
Learning Objectives:
Recognize the impact of companion diagnostics on treatment
Discuss the regulatory thinking in respect of combinations of diagnostics and treatments.