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KEY CONSIDERATIONS FOR DEVELOPMENT AND APPROVAL OF COMPANION DIAGNOSTICS

Track:
Regulation of Medical Devices and Combination Products

Day & Time:
March 27, 2:00PM - 3:30PM (Central European Standard Time)

Session Number:
1107

Room Number:
Room I

Type:
Session

Title:
KEY CONSIDERATIONS FOR DEVELOPMENT AND APPROVAL OF COMPANION DIAGNOSTICS

Chair(s):
Shuna Mason
Head of Regulatory
CMS Cameron McKenna LLP, United Kingdom

Description:
An overview of the current and prospective EU regulatory frameworks for companion diagnostics including CE marking requirements and the parties and regulatory authorities involved. The session will include analysis of the significance of the proposed changes for manufacturers of companion diagnostics and associated pharmaceutical companies looking at the EU legal and patient access frameworks and challenges. The “regulator’s” perspective will also be covered in the form of a notified body’s view of the likely impact of the new regulatory framework upon the relationship between companion diagnostics manufacturers and their notified bodies.

Presentation(s) & Speaker(s):
Development of EU Regulatory Framework for Companion Diagnostics
Shuna Mason
Head of Regulatory
CMS Cameron McKenna LLP, United Kingdom

Companion Diagnostics - A Notified Body’s view
Sue Spencer
Head of IVD
BSI Group, United Kingdom

Companion Diagnostics – reimbursement and market access
Markus Buecheler
Research Fellow
Charité Universitätsmedizin Berlin, Germany