Posted 09 May 2022 | By
Conference Committee co-chair Siegfried Schmitt
Organizers of this year’s RAPS Euro Convergence conference are striving to bring attendees both continuity and innovation, combining the excellence of past Convergence events with the latest advances in drug and device development and insights from regulators.
“The world has changed so fundamentally with the COVID-19 pandemic, and we wanted to avoid the ‘yet another regulatory event’ syndrome. For that reason, we will have presenters who cover cutting edge innovations in drug development and regulators who will cover how the agencies stepped up to the challenge of super-fast-track and rolling approvals,” said Siegfried Schmitt, PhD, vice president, technical at Parexel International, who is one of the co-chairs of the RAPS Euro Convergence 2022 Conference Committee, along with Alex Laan, principal regulatory consultant, IVD, at NAMSA.
The conference will feature more than 50 sessions and has separate tracks for pharmaceutical, medical devices and in vitro diagnoses. Attendees will hear from more than 160 speakers over the course of the three-day event.
Another aspect that sets Euro Convergence apart from other regulatory meetings is the presence of regulators. The 2022 conference will include representatives from the National Competent Authorities, the European Medicines Agency and the European Commission. Representatives from the US Food and Drug Administration will also be participating virtually, Schmitt said.
The conference begins Tuesday in Amsterdam and will conclude on 12 May.
Schmitt said to expect in-depth discussion on the rollout of major European regulatory paradigms, including the In Vitro Diagnostic Medical Devices Regulation (IVDR), the Medical Devices Regulation (MDR) and the Clinical Trials Regulation.
In the medical devices and in-vitro diagnostics (IVD) areas, there will be presentations covering the rollout of the IVDR, including the lack of capacity at the European Union Notified Bodies and its impact on market access for IVD medical devices. Sessions will also examine the first-year experience with MDR, including the European database on medical devices (EUDAMED). For both IVDR and MDR, presenters will examine the use of real-world data to support clinical evidence development.
“In general, the everlasting divergence and convergence of the different regulatory frameworks in the EU, China, Japan, etc., remains very relevant,” Schmitt said.
On the pharmaceutical side, sessions will tackle challenges in ATMPs/Cell and Gene Therapies. “Scientific advances in this area are breathtaking, so it is not easy to keep up on the regulatory side,” Schmitt said.
Other sessions will focus on implementation of the Clinical Trial Regulation and its elements, including the Clinical Trial Information System, and how these regulations may evolve over the years.
Attendees will also be able to attend sessions on combination products and how these new regulatory initiatives will impact their development.
This year’s Plenary session, scheduled for 10 May, will tackle the possibilities of data mining and analysis of smart device and drug data repositories. “The discussion in the plenary session will address how immense amounts of data can be managed and knowledge extracted for the benefit of all,” Schmitt said. “How this is done will shape the future of regulatory affairs.”
Networking and connection
The 2022 meeting marks the first in-person Euro Convergence since the start of the COVID-19 pandemic, and Schmitt said gathering in person has many advantages. “Conferences are as much a place to learn as they are a place to meet in ways that would never be possible in the virtual world,” he said. “It’s the personal experience, being part of a community of like-minded regulatory affairs professionals.” That includes not just the conference sessions, but socializing during breaks, engaging in training sessions and attending off-site social events.
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