RAPS Euro Convergence

Description

NAMSA invites you to join us at RAPS Euro Convergence on May 13-16, 2025 in Brussels, Belgium!

About the Meeting:

“RAPS Euro Convergence is the most comprehensive regulatory affairs conference in Europe, focusing on the latest topics and developments in healthcare products in Europe and beyond — medical devices, IVDs, pharmaceuticals, combination products, regulatory business, AI, software and cybersecurity. RAPS Euro Convergence unites regulatory affairs professionals and industry partners to share and collaborate on solutions for the improvement and advancement of healthcare in Europe.”

NAMSA Speaker Session

• Title: Preconference Workshop: Clinical Evaluation – Optimizing Clinical Data and State-of-the-Art Searches for MDR Compliance
• Speaker: Paul John Risborough, BEng Hons, Principal Regulatory Consultant at NAMSA
• Date/Time: Tuesday, May 13, 2025 | 08:30 – 16:00 CEST
• Description: This workshop provides practical methods for optimizing search strategies for both clinical data retrieval and SOTA assessment.

• Title: Solutions Circle: Key takeaways from 4 years of expert panel views to improve your IVD evaluation
• Speaker: Beatriz Rodriguez Grande, PhD, Regulatory Consultant at NAMSA
• Date/Time: Wednesday, May 14, 2025 | 13:15 – 13:45 CEST
• Description: Identify common weaknesses in performance evaluations and have tools to address them including the ability to: a) improve clarity and structure in a PER; b) write a more complete state of the art and use it to provide context for discussion of benefits.
  Check for common misalignments between IFU and PER and decrease the number of non-compliances in a PER.

• Title: Navigating the intersection of MDR and HTA: Strategic implications for medical device manufacturers
• Speaker: Thomas Miramond, PhD, MSc, M-Eng., Senior Regulatory Consultant at NAMSA
• Date/Time: Thursday, May 15, 2025 |  12:00 – 13:00 CEST
• Description: Gain a thorough understanding of the regulatory frameworks of the MDR and HTA, including their interdependencies and implications for market access. Identify potential risks associated with the misalignment of MDR and HTA strategies and develop mitigation plans to avoid non-reimbursement, delays, additional costs, and market access barriers in EU. Learn practical strategies to align clinical evaluation processes with both MDR and HTA requirements, focusing on obtaining a positive CECP opinion and how to get official EU Commission strategic recommendations through the scientific advice process.

• Title: Device – Drug Borderlines – challenges in Europe and the USA
• Speaker: Jane L. Arnold-Round, B.Eng Msc., Senior Principal Regulatory Consultant at NAMSA
• Date/Time: Friday, May 16, 2025 | 11:45 – 12:45 CEST
• Description: Understand the primary and ancillary modes of action and their relevance to borderline product classification under MDR. Analyze the regulatory and clinical impacts of MDR’s rule 14 and the implications of the Genus ruling on regulatory strategies for combination products in the EU and US. Develop practical strategies to navigate new compliance requirements, manage risks, and foster innovation in product development.

COMPLIMENTARY CONSULTATIONS
Visit us at Booth 8 for complimentary 30-minute consultations with NAMSA’s experts throughout the event. We welcome the opportunity to discuss with you the most cost-effective pathways to market based on your unique product development requirements.

Please email us at communications@namsa.com to reserve your consultation time, or simply stop by the booth in the exhibitor area to meet with us. We hope to see you there!