Euro Convergence 2023 delves into MDR/IVDR, EU pharma reform, and more

The proliferation and intersection of regulations governing health care products in Europe and across the world is driving calls for harmonization of marketing requirements. This year’s Euro Convergence conference will focus on the theme of harmonization through regulatory confluence.

“Regulators and industry are all interested in harmonization as much as possible, but there are limitations to all of this and therefore it is important to understand where the limitations are and what the differences are,” said Siegfried Schmitt, vice president, technical at Parexel International, who is one of the co-chairs of the RAPS Euro Convergence 2023 Conference Committee, along with Alex Laan, head of the IVD notified body for BSI.

The conference runs from 10-12 May in Amsterdam, the Netherlands, and will feature session tracks dedicated to hot topics in pharmaceuticals, medical devices and in vitro diagnostics (IVD), as well as sessions addressing the crossover in these areas.

Program highlights

This year’s conference will explore the tension between the need for stringent regulation and the time and flexibility needed by industry to adapt to the new regulatory environment, Schmitt said.

The conference kicks off with a plenary session on 10 May that is focused on leveraging joint clinical data from sources such as the CTR database and EUDAMED. The plenary session will examine the transparency of these databases and whether they will provide helpful insights for clinical practice. The panel includes regulators, representatives from industry, as well as a clinician and an investigative journalist.

The medical device track will include sessions on EU regulations that govern health data from medical devices, MDR implementation and regulatory compliance for AI/machine learning-based medical software. On the diagnostics side, sessions will cover the IVDR transition amendment and whether it will allow IVDs to be certified on time.

Pharmaceutical sessions will delve into the changes proposed in the European Commission’s revision of the EU general pharmaceutical legislation and the potential impact on innovation. These sessions will include panelists from the European Commission and the European Medicines Agency (EMA), said Kate Stockman, a member of the Euro Convergence Program Committee and vice president of regulatory affairs for Europe, Middle East and Africa for Kenvue.

“It’s the biggest and the most ambitious reform of pharmaceutical legislation in over 20 years, with a massive impact on how we, as industry, will approach development,” Stockman said. “There’s a lot of implications under that pharma law.”

The conference will also feature sessions on combination products, artificial intelligence/machine learning, real-world evidence, data-driven regulatory science and cybersecurity.

The conference is aimed at giving attendees a sense of the overall landscape of regulations today, as well as what is coming in the future, said Leo Louis, a member of the Euro Convergence Program Committee and regulatory affairs director for Philips International B.V. The conference also includes case studies to show attendees how their peers have implemented regulatory requirements in practice, he said.

Poster sessions are another vital component of the conference, Schmitt said. “You will find a lot of wonderful, exceptional posters that would normally warrant a presentation,” he said. “Going to the poster session is not an afterthought. It’s something that is vital to the whole event.”

Regulator presence

One of the standout parts of Euro Convergence is the attendance of regulators. Schmitt said there will be speakers and attendees from the European Commission, the national competent authorities and EMA, who will share their perspectives on current regulatory implementation and the potential for harmonization.

“We are extremely lucky to have the full support of the regulatory agencies,” he said.

Stockman noted that regulators are more accessible for discussion at the conference, and attendees will have a chance to get a sense of the thinking that underlies regulatory decisions. “It feels a bit more professional to professional,” Stockman said. “It’s in a setting where everyone is a regulatory professional.”

Schmitt advised attendees to remember that there are two aspects of Euro Convergence – the educational content of the sessions and the social interaction and networking. Social events and coffee breaks are critical places to connect with colleagues. “This is where you meet people and learn about things you didn’t expect,” he said.