Towards a Policy & Regulatory Framework for In Silico Medicine

EFGCP Webinar


Event Webinar
Type Virtual Event
Language English
Date(s) 27 Feb. 2018
Day(s) 16:30 - 17:30
Duration 1 hour

No matter how predictive or advanced a computer model is, it is commercially useless if it is not accepted by regulators in the assessment or reimbursement of healthcare technologies. This reality today represents one of the biggest barrier to the uptake of computer modelling and simulation in healthcare.

In this webinar we will explore what regulatory and policy systems have been put in place in the US and what is needed in the EU. What would a comprehensive CM&D policy mean for HTA? Can our very concept of patient safety remain the same in a future full of computer modelling and simulation? Join us in answering these questions and more.


16:30 Opening of the Webinar
16:35 Presentation
Moderator(s): Peter O'Donnell , Brussels Correspondent, APM Health Europe / European Columnist, Applied Clinical Trials
James Kennedy, RPP Healthcare
Nikolai C. Brun, Danish Medicines Agency
Tina Morrison, FDA, US perspective
17:30 End of the Webinar