Back to Agenda
EU Combination Products – Opportunities and Challenges
Session Chair(s)
Thomas Wejs Møller, MBA, MSc
Director Global Regulatory Affairs - Devices
Novo Nordisk, Denmark
Bringing innovative combination products to the European market is challenging due to divergent/opposing legislation. Innovation is being continuously challenged by a fragmented regulatory system that does not appropriately support the development of products (e.g. convergent technologies) that cut across legislative frameworks. Even though the European Commission, European Medicines Agency, and Head of Medicines Agencies are working to close the gaps and improve the regulatory system, there is an underlying structural challenge which limits innovation and improvement for about a quarter of all treatments under development for European patients. All presenters will shortly via two slides and 4 minutes present their perspective and experience on EU combination product regulation, followed by a discussion of the key challenges faced by both industry and regulators.
Learning Objective : This presentation aims to share some more in-depth perspectives on the regulatory challenges with Drug-Device Combination products, and some of the built-in structural obstacles and point to ways of jointly improving the area within the current setup and point to a future new regulatory approach to Drug Device products.
Speaker(s)
Working Under Combination Product Regulation in the EU – Short Legislative Intro to Art. 117
Thomas Wejs Møller, MBA, MSc
Novo Nordisk, Denmark
Director Global Regulatory Affairs - Devices
Combination Product Development and Lifecycle Management - Where Are We Now – and Where Should We Focus in the Near Future? – Industry Perspective
Esteban Herrero-Martinez, PhD
AbbVie, United Kingdom
Director Regulatory Policy and Intelligence
Alberto Ganan Jimenez, PhD
European Medicines Agency, Netherlands
Head of Committees and Quality Assurance
NB Perspective to EU Combination Products
Jonathan Sutch, PhD
BSI Group, United Kingdom
Principal Medicinal Technical Specialist
HMA Perspective on the Challenges
Bjorn Eriksson
Medical Products Agency, Sweden
Have an account?