Euro Convergence 2023: Sessions explore innovation and regulatory challenges

This year’s Euro Convergence conference in Amsterdam will feature in-depth updates on the regulatory landscape, including changes to the European Union general pharmaceutical legislation, implementation of the IVDR transition amendment and delays to the MDR deadlines. Attendees can also catch up on the latest developments in cross-cutting areas of cybersecurity, artificial intelligence/machine learning, real-world evidence and more.

Here's a day-by-day look at some of the session highlights. Full details and speaker slides are available in the online program or through the conference app.

Thursday, 11 May

Confused about the MDR rollout? From 9:00-10:00 CEST on Thursday, 11 May in Pearl 2, regulators and notified bodies will be presenting on the MDR implementation in the eight months that followed publication of the MDCG 2022-14 position paper. They will also discuss how the implementation has impacted Notified Body capacity and where improvements can be made.

At the same time, in Pearl 1, attendees will hear updates on the EU general pharmaceuticals legislation during a session titled “Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 1). The session speakers, which include representatives from the European Commission and the European Medicines Agency, will discuss the potential impact of the proposed changes on innovation. Part 2 of this session will be held from 10:30-11:30 CEST in Pearl 1.

From 10:30-11:30 CEST in Pearl 2, attendees can hear case examples of how to identify measurable outcome parameters and acceptance criteria for medical devices under MDR. The session, titled “Clinical Evaluation: Measurable Outcome Parameters: Much More Than a Requirement for an MDR-Complaint CER,” will include tips on how these endpoints can be integrated into the design of premarket clinical investigations, PMCF surveys and other clinical studies.

From 11:45-12:45 CEST in Pearl 2, panelists will share their strategies for how to navigate the MDR’s clinical assessment process and minimize questions from Notified Bodies. The presentations include a review of the process and the expectations for high and low risk devices. Also, from 11:45-12:45 CEST in Pearl 3, attendees can get up to date on new developments in UK regulations for IVDs. The first half of the session focuses on the regulatory changes taking place in the UK, including UKCA marking. The second half of the session will focus on opportunities created by the UK regulatory scheme, including access to flexible routes to market and broadening the use of electronic labeling.

During the lunch break, attendees can explore a variety of topics through half-hour sponsored sessions. From 13:00-13:30, there will be sponsored sessions on regulatory frameworks around cybersecurity, how the EU MDR is impacting innovation of medical devices, tips for using the FDA’s eSTAR submission process and regulatory strategies for EU orphan drug development. 

Regulatory compliance for AI/machine learning based-medical software can be complex. From 13:45-14:45 CEST in Pearl 1, panelists will review the key phases of the machine learning model development lifecycle, including case studies and pilot projects that shed light on the current thinking of regulators. The session also features a use case of an innovative startup developing AI medical software related to mammography.

Additional sessions on Thursday 11 May explore the latest developments and controversies in data security, device traceability, regulatory tools for advanced therapies, companion diagnostics, in-house IVDs, orphan medicines, regulatory training and more.

Friday, 12 May

Friday, 12 May kicks off with “Conversations That Matter: Interactions with Health Authorities,” from 8:45-10:00 CEST in Pearl 1, 2 and 3. The session features a panel of European regulators and notified bodies for an interactive discussion covering pharmaceuticals, combination products, diagnostics, medical devices and where they overlap. Attendees are encouraged to come with questions.

From 10:45-11:45 CEST in Pearl 1, former FDA and notified body officials will gather for a discussion of recurrent regulatory deficiencies related to software in FDA submissions and EU technical documentation. The topic will be explored through case studies, as well as a discussion of best practices and solutions.

Regulatory science is another hot topics at this year’s conference. From 12:00-13:00 CEST in Carmine & Charcoal, a representative from the European Medicines Agency and the Medicines Evaluation Board will explore the Accelerating Clinical Trials in the EU (ACT EU) initiative, plus the Big Data Steering Group Work Plan and the Data Analysis and Real-World Interrogation Network (DARWIN EU).

From 13:15-13:45 CEST, there are a variety of sponsored sessions that will focus on topics including digitized regulatory intelligence, creating a regulatory-clinical strategy, data consistency in global regulatory platforms versus integrations, tips for streamlining regulatory affairs and the impact of AI on medtech.

Cybersecurity is an increasing focus of regulation. From 14:00-15:00 CEST in Carmine & Charcoal, a representative from TÜV SÜD Product Service GmbH, Germany, will explore why cybersecurity is an essential part of the design and development of IVD medical devices and how test evidence can be used in a successful conformity assessment with a Notified Body. At the same time, in Pearl 1, attendees can hear about efforts to include pregnant women and pediatric populations into clinical development.

The conference’s final panels will take place from 15:30-16:30 CEST. In Carmine & Charcoal, panelists will outline the European expedited approval pathways and put them in a global context. The session includes a representative from the European Medicines Agency who will break down the development timelines and explore challenges related to COVID-19, resources and communication. A simultaneous panel in Pearl 1 will discuss the impact of the MDCG 2022-14 position paper on Notified Body capacity. The session features representatives from notified bodies and explores the impact on review and audit time.

Friday sessions also include a variety of other topics including device lifetime and lifecycle management, EMA’s PRIME scheme, real-world evidence, UKCA certification, expedited approval pathways and more.

Be sure to stick around for the Chapter/Local Networking Group Meet and Greets from 16:00-16:45 CEST at Foyer 1, followed by Closing Remarks & Farewell Toasts at the patio outside the main entrance from 16:30-17:00 CEST.