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Radisson Grand Place

Jan 30, 2024 8:00 AM - Jan 31, 2024 6:30 PM

47 Rue du Fossé aix Loups, Brussels, Belgium

2024 Combination Products in the EU

Overview

DIA and RAPS are excited to collaborate for the first time to jointly produce the 2024 summit on Combination Products in the EU. This highly-interactive summit will unite key stakeholders across the field - including representatives from EMA, the European Commission, Notified Bodies, National Competent Authorities and Industry - to explore a coordinated drug and device approach for bringing innovation back to Europe.

 

With a distinct focus on finding solutions and creating efficiencies, the 2024 summit on Combination Products in the EU offers attendees a comprehensive overview of the current status of the EU MDR implementation, examining the nuances of Article 117 and discussing the process of obtaining notified body and competent authority opinions. In addition, the event provides a unique forum for discussing the implications of the new EU Pharmaceutical Legislation on bringing combination products to market.

 

Throughout the summit, experts will exchange ideas via action-oriented working groups that stimulate ideation and innovation, designing solutions for pragmatic implementation.

 

By exploring current challenges and opportunities to unite for better pathways forward, the programme will highlight critical topics such as labelling, connected devices, software as a medical device, clinical trials, post-marketing clinical follow-ups, sustainability, and the application of Human Factors Engineering.

 

Who should attend?

This highly-interactive summit will unite key stakeholders across the profession - including representatives from EMA, the European Commission, Notified Bodies, National RegulatoryAuthorities and Industry - to explore a coordinated drug and device approach for bringing innovation back to Europe.

 

Learning objectives

  • At the conclusion of this activity, participants should be able to:

    • Map the current state of play and experience with the EU MDR implementation from Regulator, Notified Body, and Industry perspective, regarding the development and lifecycle management of combination products.
    • Explore different interpretations of Article 117 and the role and remit of key stakeholders
    • Examine the impact of the new EU General Pharmaceutical Legislation on Combination Products
    • Review country-specific requirements and their impact on clinical trials for combination products

Audience Learning Level

 

Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.

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