RAPS Convergence was an excellent opportunity to connect and learn more about the latest developments within the industry. During the event, attendees and exhibitors had the chance to visit our Booth 514, where they engaged with our team of knowledgeable consultants specializing in IVD, MD, clinical, and global registrations. It was an enriching experience as they could ask questions, gain valuable insights, and discover how Qserve could effectively support their regulatory needs.
Pictured above: Our experts engaging with attendees.
The Convergence began with preconference workshops where Keith Morel, VP of Regulatory Compliance US and Principal Consultant, presented in a workshop titled PRRC – A New EU Requirement. During this workshop, Keith expertly guided attendees through the intricacies of the PRRC role, shedding light on the 'who' and 'how' of acting as a PRRC. The session served as a valuable educational opportunity, ensuring that participants left with a comprehensive grasp of the responsibilities and requirements associated with this crucial role.
Christie Hughes, IVD Expert and Principal Consultant, spoke as part of the preconference workshop for US Regulatory Essentials for Devices. For her part of the workshop, she reviewed how the US FDA defines, classifies, and regulates in-vitro diagnostic (IVD) devices. She also described the steps necessary to get IVD devices on the US market as well as tips for working successfully with the FDA.
Pictured above: Gert and Danielle's session for Career Development.
Gert Bos, Executive Director and Partner, and Danielle Motta, Head of Global Registrations, participated in a panel titled Career Development Session for Students which featured regulatory experts who shared advice on entering the regulatory affairs profession. The next generation of regulatory experts started their RAPS journey with a Career Development session. A panel of experts guided/advised the students from different universities on entering the regulatory affairs profession.
Key takeaways from the session include: Don't hesitate to ask questions, as it's perfectly fine not to know everything. Always have a concise self-introduction ready, including your name, interests, and event purpose. Additionally, remember to maintain eye contact and offer a firm handshake when engaging with others to create a positive initial impression.
Pictured above: Gert speaking in the opening session.
In the Convergence opening session, Gert shared his extensive experience within RAPS and the Convergence event. He provided valuable insights and offered words of advice, particularly directed at newcomers. Gert's remarks served as a source of inspiration and guidance, emphasizing the importance of active participation and networking in maximizing the benefits of the Convergence experience.
The first official day of the Convergence began bright and early with Gert Bos presenting in a session titled EU-MDR Implementation: Latest News. He talked through the negative emotions associated with the MDR implementation and the challenges and opportunities for all impacted stakeholders. He indicated many companies are moving their focus to other markets and with collected PMCF data return to EU later. Gert also called for more specific guidance and centralization of support to reduce confusion.
Pictured above: Dr. Diane M. Ward presenting in the solutions circle.
In the afternoon, Dr. Diane M. Ward spoke about Getting it Right the First Time - Where Regulatory and Design Intersect; Accuracy/Acceptance Criteria. In the session, it was discussed how the accuracy of an assay is the ultimate performance metric and that all other analytical studies are done to ensure that this performance requirement is met. Understanding how to derive the acceptance criteria for these various verification studies that are required to support a regulatory submission given a product’s intended use is critical to ensuring we design safe and effective products.
On the final day of the Convergence featured Gert assisting in a Solutions Circle: EU/MDR State of Play. Once again speaking as an expert on the state of the EU MDR and how to navigate the ever-changing landscape.
Danielle’s well-attended session, Tackling a Whirlwind of Uncertainties: Lessons Learned on UK Market Access, shed light on the process towards the new GB legislation for medical devices and IVDs and associated timelines. The presenters combined perspectives from different stakeholders (Phil Brown from ABHI and Balazs Boszik from SGS) to give insight into the delta between foreign regulations and the upcoming requirements for the UK market. Although the new requirements for devices seem quite clear, there are still a lot of uncertainties. By discussing the ‘knows’ and ‘unknowns’ they’ve guided manufacturers on what they can do today! From the discussion on how the statutory instrument is build-up, a newly introduced innovative pathway, potentially leveraging overseas approvals other than EU towards the direct impact on the technical documentation, manufacturing processes and quality management system.
Pictured above: Keith Morel, PhD leading a session.
Finally, Keith presented Servicing Medical Devices – What Parts or Components SIGNIFICANTLY Change the Performance or Safety (Art 23). In this informative session, participants learned about the various approaches used to define "significant change" in the context of service and maintenance for medical devices and applications. This session aimed to clarify when modifications could be made without the necessity of notifying regulatory authorities. Furthermore, the compliance implications of these different approaches were thoroughly explored, providing participants with a comprehensive understanding of how to manage regulatory compliance within the realm of medical devices and apps.
Overall, the Convergence atmosphere was filled with enthusiasm as professionals from various corners of the regulatory affairs field came together to share experiences and knowledge. It was truly a memorable occasion that allowed us to connect with like-minded individuals and strengthen our commitment to regulatory excellence.
We appreciate everyone who stopped by our booth and engaged with us. Your interest and participation made RAPS Convergence a resounding success. We look forward to the opportunity to continue supporting you in your regulatory endeavors in the future. See you in Berlin for Euro Convergence 2024!