Back to Agenda
Mind the Gap - Disentangling the Maze of Drug-Device Combination Product Approval in the EU
Session Chair(s)
Zaide Frias, PharmD
Head of Digital Business Transformation Task Force
European Medicines Agency, Netherlands
Maren von Fritschen, PharmD
Head EU Regulatory Policy
Moderna, Netherlands
Drug Device Combinations (DDCs) with innovative treatment options are bridging the divide between pharma & medical device sector. An integrated evaluation pathway for these products is needed to ensure timely access for patients to innovative treatments - how to improve the system within the legal framework to be fit for future?
Speaker(s)
Overview of the legal framework and the need for an integrated evaluation pathway
Zaide Frias, PharmD
European Medicines Agency, Netherlands
Head of Digital Business Transformation Task Force
Innovative concepts of DDC products on the horizon – what can we expect from industry?
Maren von Fritschen, PharmD
Moderna, Netherlands
Head EU Regulatory Policy
How to support the development of innovative DDC in the EU – from a national Authority’s perspective
Laurence O'Dwyer, RPh
Health Products Regulatory Authority, Ireland
Scientific Affairs Manager
How to Navigate the Maze of the New Requirements on Drug-Device Combination Products for Industry – Challenges and Pragmatic Approach
Lars Hyveled-Nielsen, MPharm
Zealand Pharma, Denmark
Regulatory Project Director
Towards an integrated pathway for DDC products, elements of a collaborative approach from a NB perspective
Bassil Akra, PhD
QUNIQUE GmbH, Germany
CEO
All speakers and patient representative
David Haerry
EUPATI Foundation,European AIDS Treatment Group, Belgium
Co-Chair Advisory Committee
Have an account?