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DEVELOPMENT AND REGULATORY FRAMEWORK FOR COMPANION DIAGNOSTICS
Session Chair(s)
Thomas Metcalfe, MBA
Personalised Healthcare Ecosystems
F. Hoffmann-La Roche, Switzerland
Personalised medicine and pharmacogenomic tests: from label to clinical practice
Learning Objective : The participant will become aware of the: -difference in transparency between medicines and medical device legislation -absence of a link between pharmacogenomic tests used in clinical studies and clinical practice -limited implementation of pharmacogenomic testing in clinical practice guidelines
Speaker(s)
Regulatory Oversight of Companion Diagnostics - current and future plans
Shuna Mason
CMS Cameron McKenna LLP, United Kingdom
Head of Regulatory
Developing a Companion Diagnostic: How pharma and IVD companies need to co-operate, and liaise with authorities including case studies
Tim Kievits, MSc
VitrOmics, Netherlands
Director of Healthcare Innovation
Personalised medicine and pharmacogenomic tests: from label to clinical practice
Marjolein Weda, PharmD, PhD
RIVM, Netherlands
Senior scientific officer
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