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Agenda Overview

Monday, 2 November
16:30 — 21:00 CET

Registration Opens
16:30 CET

Welcome Reception
18:00 — 21:00 CET
Tuesday, 3 November
7:30 — 22:30 CET

Networking Breakfast
7:30 — 8:15CET

Innovation Theater
7:50 — 8:10 CET

See how ³Ô¹Ï±¬ÁÏ AI unlocks regulatory insights for all levels of the organization from executives to global leads to submission managers and publishers.


Opening Keynote
8:30 — 9:30 CET

Sessions
09:45 — 10:45 CET

Transform clinical evidence form a regulatory requirement to a strategic tool by integrating real-world evidence data across the product lifecycle to accelerate market access.

John McDonald Teleflex
Senior Director Clinical Evidence Generation
Richard Holborow BSI
Head of Clinical Compliance

Join leading experts from regulatory authorities and notified bodies for a holistic discussion on navigating today’s fast-changing medtech landscape. This panel explores current authority priorities, dynamic access pathways, and the shift toward a total product lifecycle model—demonstrating how syncing cross-functional data enables agile, continuous compliance while keeping your product strategy ahead of regulatory change.

Alexey Shiryaev DNV Product Assurance AS
Director of Certification
Rob Reid MHRA
Deputy Director, Innovative Devices
Alex Laan BSI
Head of IVD Notified Body

Learn how embedding ³Ô¹Ï±¬ÁÏ AI into PromoMats workflows accelerates content velocity, improves asset quality, and supports compliant review and approval processes. Discover practical strategies for driving adoption and scaling AI across the content lifecycle.

Rebecca D. Brasher Medtronic
Regulatory Affairs Director- Ad Promo and Regulatory Labeling

Chief Medical Officers share strategies for transforming the medical function into a core business driver. Discover how to break down legacy silos and leverage data-driven strategies to drive growth and enterprise-level objectives.


Connect Break
10:45 — 11:30 CET

Innovation Theater
10:50 — 11:10 CET

See how Vault AI in PromoMats enhances medtech content reviews, combining human expertise with AI precision to strengthen compliance, accelerate speed to market, and increase productivity.


Sessions
11:30 — 12:15 CET

Get a blueprint for successful RIM implementation including goal and metric definition, multi-year roadmap planning, and change management; regardless of company size.

Sandra Racordon-Pape Cytiva
Director Regulatory Science and Strategy

Learn how factors like culture, legacy tech, and M&A shape how leaders define their vision and drive an adaptable quality transformation roadmap.

Koen Verhaert Terumo Europe N.V.
Vice President Quality, Regulatory & Vigilance

Discover how unifying customer data creates a predictive, actionable engine for commercial teams. See how a global medtech uses solid data foundations to align marketing and sales, streamline field workflows, target high-value accounts, and scale globally.

Blake Avery Dexcom
Director, Commercial Excellence, EMEA

Learn from medical affairs innovators as they share their playbooks and industry benchmarks for building a digital infrastructure that measures organizational impact and gains leadership credibility.


Sessions
12:30 — 13:15 CET

See how ³Ô¹Ï±¬ÁÏ MedTech is developing regulatory solutions to fit the needs of the modern medtech.

Hear about the most recent and upcoming ³Ô¹Ï±¬ÁÏ Quality Cloud features across QualityDocs, QMS, and Training, alongside new AI and platform innovations optimizing the user experience

Building a scalable foundation for claims management by creating a single source of truth for claims and standardized MLR processes to accelerate time-to-market and mitigate compliance risk.

Jos Brunner Philips
Claims Program Manager

Scaling modern medtech Medical Affairs requires breaking down critical operational roadblocks. Explore how to solve these friction points by blending agile cross-functional processes with targeted technology.


Networking Lunch
13:15 — 14:45 CET

Innovation Theater
14:00 — 14:20 CET

See how platform, standard, and custom agents drive rapid customer value and continuous innovation for quality.


Sessions
14:45 — 15:30 CET

Learn how BD is reducing errors, easing administrative site burden, and automating data verification by eliminating manual transcription of patient-reported outcome and clinical-reported outcome data. They will share how to transition away from fragmented tools and workflows to a unified platform with real-time data visibility and operational efficiency.

Christy Zeigler Becton Dickinson and Company
Director, Clinical Data Management

Learn how developing a lean quality process landscape optimizes technology adoption, breaks down functional silos, and unifies core Quality workflows like complaint handling, CAPA, and change control.

Handan Yildiran Coloplast
Director QA Compliance, Global Quality

Learn how robust program governance aligns clinical, regulatory, and commercial priorities to ensure your tech transformation drives maximum value across the product lifecycle.


Sessions
15:45 — 16:30 CET

The ³Ô¹Ï±¬ÁÏ Clinical team will cover recent releases and new features planned for the upcoming year. Learn about new features across the ³Ô¹Ï±¬ÁÏ Clinical Platform.

Discover how AI agents are redefining regulatory operations by easing heavy workloads and supporting critical decisions. We'll explore how ³Ô¹Ï±¬ÁÏ AI for regulatory submissions executes automated quality checks, strengthens compliance, accelerates time-to-market, and maximizes productivity across the content lifecycle.

Move from a compliance-driven operations to an innovation engine led by a culture of quality. Learn how cross-functional collaboration and standardization ensure a patient-centric focus.

Nia van Baalen Siemens Healthineers (Varian)
VP, Commercial Product Quality

Showcasing how ³Ô¹Ï±¬ÁÏ PromoMats, Vault CRM, and Link Key People work together in ³Ô¹Ï±¬ÁÏ Commercial Cloud to align sales execution, digital content, and real-time HCP intelligence for targeted customer engagements.

Break down how the rise of AI tools changes how clinicians find and consume scientific data. Learn how these shifting user habits can impact omnichannel stakeholder engagement, information dissemination, and the future of medical communications.


Connect Break
16:30 — 17:15 CET

Innovation Theater
16:40 — 17:00 CET

Learn how ³Ô¹Ï±¬ÁÏ EDC, DQS, and CTMS enable a risk based approach to study management


Evening Event (National Maritime Museum)
18:30 — 22:30 CET



Wednesday, 4 November
8:00 — 15:30 CET

Networking Breakfast
7:30 — 8:45 CET

Innovation Theater
8:30 — 8:50 CET

Learn how to optimize the end-to-end expert journey with ³Ô¹Ï±¬ÁÏ Medical Suite. Identify the right experts, track interactions, and co-develop peer-reviewed publications to drive market access and advance standards of care.


Sessions
9:00 — 9:45 CET

Clinical evidence requirements are shaping digital transformation and AI strategies for medtechs. Hear from three leading medtechs on how clinical evidence generation is influencing their long-term clinical strategy, organizational structure, and business objectives

Regulators and industry experts share current and future state of electronic regulatory submissions, including trends, pitfalls, and evolving compliance expectations

Tom Patten GMED
IVDR International Manager
Steve Lee ABHI
Head of Regulatory

Eliminate bottlenecks, improve data integrity, and reduce cycle times with digital validation management.

Modern medtech purchasing decisions involve multiple stakeholders, requiring precise and compliant commercial alignment. See how a leading medtech masters the end-to-end buyer journey to deliver impactful, tailored customer experiences.

Compliantly bypass local entry barriers by leveraging precision expert mapping and cross-border institutional alliances. Get actionable frameworks to align global scientific leaders and accelerate international commercial adoption.


Sessions
10:00 — 10:45 CET

Learn how a connected clinical ecosystem serves as the foundation for modern AI integration. We'll review use cases across the trial process including strategies for AI readiness, governance, and operational impact.

Customization can perpetuate broken workflows, but standardization helps maintain clean data architecture for faster launches and future AI agents.

Brian Banta Novocure
Senior Manager, Business Process Engineering

Rethink quality and product innovation with risk-based decisioning to streamline systems and processes, maintain continuous compliance, and deliver greater value to patients.

Emiliano D'Urso Tosoh Corporation
PMS & Regulatory Intelligence Manager EMEA
Markus Pöttker Smith+Nephew
Director, Global Post-Market Surveillance

Disconnected commercial tools lead to wasted marketing investments and missed insights. Explore how to bridge the gap between content creation and field execution to deliver seamless, compliant interactions and fuel a continuous data feedback loop.

See how the ³Ô¹Ï±¬ÁÏ Medical Suite advances each step of the Medical Affairs lifecycle, including key medical responsibilities across stakeholder identification, scientific exchange, and inquiry management to show how a unified digital ecosystem drives efficiency and deep clinical insights.


Connect Break
10:45 — 11:30 CET

Innovation Theater
11:00 — 11:20 CET

Learn how ³Ô¹Ï±¬ÁÏ AI combines with the ³Ô¹Ï±¬ÁÏ Clinical Platform to streamline processes and reduce manual work.


Closing Keynote
11:30 — 12:15 CET

Networking Lunch
12:15 — 13:30 CET

Innovation Theater
12:30 — 12:50 CET

See how ³Ô¹Ï±¬ÁÏ QMS streamlines end-to-end complaint processing, contact communication, and resolution.


Sessions
13:30 — 15:30 CET

Collaborate with your peers and ³Ô¹Ï±¬ÁÏ experts during an open discussion on clinical best practices and how to leverage ³Ô¹Ï±¬ÁÏ Clinical applications to drive efficiency. We'll also dive into the latest features.

Collaborate with your peers and ³Ô¹Ï±¬ÁÏ experts during an open discussion on regulatory best practices and PLM. We'll also dive into the latest features of ³Ô¹Ï±¬ÁÏ RIM.

Collaborate with your peers and ³Ô¹Ï±¬ÁÏ experts during an open discussion on quality best practices and how to leverage Quality applications to drive efficiency and safety. We'll also dive into the latest features of the Quality Platform.

Collaborate with your peers and ³Ô¹Ï±¬ÁÏ experts during an open discussion on commercial and claims management best practices and how to leverage Commercial Content applications to drive efficiency, compliance, and speed to market. We'll also dive into the latest features.