Hear the latest innovations and new product announcements, including how to streamline the total product lifecycle.
10:00 — 10:45
CET
Alcon: Connecting Patients, Sites, and Sponsors with a Unified Clinical Platform
A global medtech will share insights on their clinical transformation to ensure clear vision across operations and data management. They'll share strategies for unifying end-to-end processes and lessons learned throughout the digital transformation journey.
Leianne Ebert
Head Of Clinical Data Operations
Alcon
With over 15 years experience leading global teams in operations, data management, and systems, Leianne is an established leader in clinical research. As head of data management at Alcon, she is also the business lead for the Veeva Vault CDMS implementation.
Sessions
Alcon: Connecting Patients, Sites, and Sponsors with a Unified Clinical Platform
Heidi is commited to advancing clinical development in eye care, prioritizing innovative solutions to improve patient and site experiences in clinical trials. She champions talent development and continuous improvement, all with the goal of helping people see brilliantly.
Sessions
Alcon: Connecting Patients, Sites, and Sponsors with a Unified Clinical Platform
Wednesday, 6 November
10:00 CET
Heidi Ortiz
VP, Clinical Operations Functions
Alcon
Axon, Scarlet: Decoding the AI Act's Impact on Medtech
The AI Act is a pivotal milestone in artificial intelligence regulation, but how will it affect the healthcare ecosystem? Join industry experts in a discussion on the drafting of the regulation, how it will meet safety and performance criteria, and why it may be a strategic advantage rather than a barrier to market entry.
James Dewar
CEO
Scarlet
After graduating with a masters in AI & machine learning from Imperial College, James worked as a data scientist before co-founding Scarlet with Jamie Cox to hasten the transition to universally accessible and affordable healthcare. He has spent nearly four years developing Scarlet into Europe's only software and AI-specialized notified body, which certifies medical software under MDR more efficiently and frequently than ever before.
Sessions
Axon, Scarlet: Decoding the AI Act's Impact on Medtech
Wednesday, 6 November
10:00 CET
James Dewar
CEO
Scarlet
Erik Vollebregt
Partner
Axon Lawyers
Erik specialises in EU and national legal and regulatory issues relating to medical devices, IVDs, medicines and biotechnology, with a focus on legal and regulatory advice, contracts, regulatory litigation against competent authorities and M&A. Erik is the author of the acclaimed Medicadeviceslegal.com blog and The Enriched MDR and IVDR handbook.
Sessions
Axon, Scarlet: Decoding the AI Act's Impact on Medtech
Wednesday, 6 November
10:00 CET
Erik Vollebregt
Partner
Axon Lawyers
GE, Philips, ZEISS: Fueling Data-driven Marketing with Organizational Change
Join this executive panel discussion on challenges and opportunities in medtech marketing. We'll explore the impact of technology, innovative strategies driving digital transformation, and practical insights on how to leverage technology to create hyper-personalized customer experiences.
Friederike von Krosigk
CSMO International
GE HealthCare
Friederike has over 20 years of experience in marketing, sales, and strategy roles across FMCG (Mondelez, Mars), Medical Devices (J&J), Pharma (Merck), and Medtech (GE). She has led customer-centric transformations, executed omnichannel strategies, and driven brand and lead generation campaigns resulting in significant business growth and enhanced sales performance.
Sessions
GE, Philips, ZEISS: Fueling Data-driven Marketing with Organizational Change
Wednesday, 6 November
10:00 CET
Coloplast & GE Healthcare: The Future of Medtech Innovation in Europe
Thursday, 7 November
11:20 CET
Friederike von Krosigk
CSMO International
GE HealthCare
Daniel Milliken
Vice President Marketing
Philips
Daniel is Vice President of Marketing and has been leading the marketing transformation for Philips Health since February 2023. This includes the restructuring and implementation of a new org design across businesses, markets, and functions. He served as Vice President of Marketing for Philips Image Guide Therapy business group from 2018 – 2022 and was Vice President of Strategy and Marketing for Image Guided Therapy Systems business from 2015-2018.
He has set up and led multiple business ventures as well as numerous marketing teams on three continents over he’s career and has a passion for driving change and challenging the status quo.
Sessions
GE, Philips, ZEISS: Fueling Data-driven Marketing with Organizational Change
Wednesday, 6 November
10:00 CET
Daniel Milliken
Vice President Marketing
Philips
Dr. Jochen Tham
Head of Digital Customer Experience
ZEISS Medical Technology
Focus on the customer experience within the scientific and medical market space. Multiple positions in Germany and the US in sales, marketing, and communication in ZEISS Microscopy and Medical technology segment. Building understanding to adapt Marketing technology to special requirements of a regulated market and in the moment driving the transformation to data-driven, platform-based engagement to create a differentiating digital customer experience.
Sessions
GE, Philips, ZEISS: Fueling Data-driven Marketing with Organizational Change
Wednesday, 6 November
10:00 CET
ZEISS: Powering AI Applications with a Vault Foundation
Thursday, 7 November
9:00 CET
Dr. Jochen Tham
Head of Digital Customer Experience
ZEISS Medical Technology
Deriving Value from Cloud Transformation
Hear how leading medtech companies are unlocking value through operational tactics like business case definition and ongoing value realization projects. We'll also review how to prioritize strategic business objectives within your technology transformation roadmap.
Chris Knerr
VP Technology Strategy
Veeva MedTech
Chris is a seasoned medtech executive and industry leader whose experience and expertise spans from leading mega-programs at Johnson & Johnson to serving as the Chief Digital Officer for a PE portfolio firm, to co-founding and leading an AI/ML tech startup. Chris holds a BA in Philosophy from Columbia University and an MBA from Cornell University, where he has been a periodic guest lecturer in digital transformation, analytics strategy, and real-world project management
Sessions
Deriving Value from Cloud Transformation
Wednesday, 6 November
10:00 CET
Chris Knerr
VP Technology Strategy
Veeva MedTech
Karl Storz, Philips: CMOs Evaluate the Medical Affairs Landscape
CMOs will share perspectives on the role of medical affairs in medtech including how to drive value, navigating challenges, emerging trends, unmet needs, and future direction.
Carla Goulart Peron
Chief Medical Officer
Philips
A physician with 15 years of combined medical practice and medical device and pharmaceutical industry leadership, Carla combines her strong clinical background with a hands-on approach to innovation to improve access to care. Prior to Philips, she held leadership roles at Medtronic and internationally recognized Brazilian companies. She has supported the development of products and services across various medical specialties and multi-country licensing. Carla holds a Medical Degree with Certification in Obstetrics and Gynecology and a Master of Business in strategic business management.
Sessions
Karl Storz, Philips: CMOs Evaluate the Medical Affairs Landscape
Wednesday, 6 November
10:00 CET
Carla Goulart Peron
Chief Medical Officer
Philips
Jens Krugmann
Chief Medical Officer
Karl Storz
An accomplished senior leader in Medical Devices, Pharma, and Consumer Healthcare, Jens has a diverse academic background in Medicine, Engineering, and Business. He is a proven change agent with clinical experience and success in leading global teams in Clinical, Medical, Regulatory Affairs, Quality, and Patient Safety.
Sessions
Karl Storz, Philips: CMOs Evaluate the Medical Affairs Landscape
Wednesday, 6 November
10:00 CET
Jens Krugmann
Chief Medical Officer
Karl Storz
10:45 — 11:30
CET
Connect Break / Refreshments
11:30 — 12:15
CET
Terumo, BSI, Q-Serve: The Impact of MDR and IVDR on Clinical Evidence Generation
The introduction of IVDR and MDR required the medtech industry to rethink clinical evidence generation. This session will explore how a notified body and leading medtech company are handling the impacts of those regulations and a continuously evolving regulatory landscape, including strategies for implementing more efficient processes while continuing to deliver new and better treatments for patients.
Gert Bos
CSO
Q-Serve
Gert is an expert in European regulations with 25+ years of experience as an auditor, regulatory specialist, and consultant. He has led notified bodies in Brussels and contributed to EU regulatory discussions. With a PhD in biomaterial sciences, Gert has reviewed numerous non-active devices and also serves as chairman of the RAPS board, a RAPS Fellow, and member of the EU board.
Sessions
Terumo, BSI, Q-Serve: The Impact of MDR and IVDR on Clinical Evidence Generation
Wednesday, 6 November
11:30 CET
Gert Bos
CSO
Q-Serve
Fintan Bergin
Senior Internal Clinician
BSI
Fintan has 6+ years of experience at BSI focusing on active and general devices and driving MDD and MDR transitions. He provides clinical oversight for certifications, PSUR reviews, and technical file assessments. He also serves as a consultant general and colorectal surgeon in the NHS, specializing in intestinal failure, inflammatory bowel disease, and abdominal wall reconstruction, including robotic surgery.
Sessions
Terumo, BSI, Q-Serve: The Impact of MDR and IVDR on Clinical Evidence Generation
Wednesday, 6 November
11:30 CET
Fintan Bergin
Senior Internal Clinician
BSI
Marie-Pierre Dewez
Clinical Affairs Director EMEA
Terumo Europe NV
Marie-Pierre has over 30 years of experience in clinical research across pharma and medical devices, including leading roles at Volcano/Philips, Boston Scientific, Cordis J&J, and Bristol-Myers Squibb. Her adaptability, proactive problem-solving skills, deep understanding of evolving industry dynamics, and ability to work with diverse, cross-functional teams have contributed to her success in complex, global environments.
Sessions
Terumo, BSI, Q-Serve: The Impact of MDR and IVDR on Clinical Evidence Generation
Paul Hartmann: Gaining Executive Buy-In for a Digital RIM Project
Before tackling a digital transformation project, it's critical to align regulatory and IT executives around a common vision. Paul Hartmann will share approaches for articulating business benefits, gaining C-suite buy-in, and mobilizing teams to ensure success.
Stefan Fischer
SVP Regulatory Affairs
Paul Hartmann AG
With more than 30 years in life sciences, Stefan has experience across quality, regulatory, R&D, Operations, Procurement, Finance, and HSE at large organizations and start-ups. He has been leading regulatory affairs for Paul Hartmann AG in Germany since 2017. Stefan has a background in engineering, a business degree, and is a certified Environmental Auditor (TUEV), Quality Auditor (ASQ) and Executive Coach (Henley University).
Sessions
Paul Hartmann: Gaining Executive Buy-In for a Digital RIM Project
Wednesday, 6 November
11:30 CET
Stefan Fischer
SVP Regulatory Affairs
Paul Hartmann AG
Key Trends and Issues for Quality Leaders
Hear how a senior quality and regulatory leaders tackles some of the medtech industry's most challenging topics. He'll touch on the cost of poor quality, AI adoption, and how quality and regulatory professionals can elevate their critical thinking skills.
Leading with Purpose: Driving Clarity Amid Change at Philips
Change goes beyond implementing new systems or processes—it's about creating clarity and aligning teams to a shared, purposeful vision. Heather will share her experiences in driving marketing excellence at Philips, leading impactful organizational change that benefits both internal teams and customers. Through real-world examples, discover how to become a catalyst for change, inspiring others and driving meaningful results.
A medtech leader since 2013, Heather is focused on driving healthcare innovation. At Philips Health Systems, she plays a key role in the Marketing Center of Excellence driving harmonization across 15 global businesses and all regions. Previously, Heather held marketing roles in brand and portfolio management at Stryker Medical. She holds dual master’s degrees in global business management.
Sessions
Leading with Purpose: Driving Clarity Amid Change at Philips
Join this session to hear how Glaukos aligned their business and technology needs to meet growing organizational requirements. They'll share how they developed a center of excellence and focused on nimble and effective solutions to reach their digital transformation objectives.
David Hohler
Sr. Director, Global Technology Solutions
Glaukos
Dave leads the global technology solution transformations team at Glaukos. He works to align business and technology needs to meet growing organizational requirements, focusing on nimble and effective solutions
Sessions
Glaukos: Bridging the Gap Between Business and IT
Wednesday, 6 November
11:30 CET
Determining Best Practices for Risk-based Testing and Validation
Wednesday, 6 November
15:15 CET
David Hohler
Sr. Director, Global Technology Solutions
Glaukos
EssilorLuxottica, Philips: Aligning Medical & Commercial to Drive Product Adoption
EssilorLuxottica and Philips share strategies to enhance medical and commercial collaboration to align medical insights with commercial objectives, including integrating processes and developing shared goals to enhance product adoption.
Dr. Norbert Gorny
Chief Scientific Officer
EssilorLuxottica
Before becoming Chief Scientific Officer at EssilorLuxottica, Dr. Norbert Gorny held roles as Chief R&D Officer and Chief Operating Officer as well as CEO of SatisLoh AG. Prior to joining Essilor, he held key executive roles at Carl Zeiss, including EVP of Microscopy, Executive Board Member, and CEO of Carl Zeiss Vision International. He began his career at McKinsey & Co. in 1994 after completing his doctorate in microbiology at the University of Tuebingen, Germany.
Sessions
EssilorLuxottica, Philips: Aligning Medical & Commercial to Drive Product Adoption
Wednesday, 6 November
11:30 CET
Dr. Norbert Gorny
Chief Scientific Officer
EssilorLuxottica
Martijn van Steennis
Global Head of Medical and Clinical Affairs, Imaging
Philips
Martijn has 10 years of medtech experience, leading teams in imaging-related medical affairs and clinical safety for MRI, CT, and diagnostic x-ray. He previously led Image-guided Therapy Innovations, launched Vygon's homecare business, and served as a para-medical military specialist in anesthesia, completing two Afghanistan tours. He holds medical degrees, an executive MBA, and a post-grad in business administration.
Sessions
EssilorLuxottica, Philips: Aligning Medical & Commercial to Drive Product Adoption
Wednesday, 6 November
11:30 CET
Martijn van Steennis
Global Head of Medical and Clinical Affairs, Imaging
Philips
12:30 — 13:15
CET
Smith+Nephew: Unlocking Our Full Potential: Cross-functional Collaboration to Drive Innovation and Business Readiness
Cross-functional collaboration between clinical operations and IT teams is critical to successfully implement new technology. Discover how Smith+Nephew has forged a robust partnership, driving innovation, ensuring business readiness, and enhancing clinical operations. They will share strategies that span clinical expertise and IT proficiency, fostering the integration of Vault eTMF.
Betsy Ballew
Senior Manager - Clinical Operations
Smith+Nephew
Betsy leads the global team supporting clinical studies and oversees eTMF operations at Smith+Nephew. She has a strong background in nursing and clinical research and holds a master’s in nursing and a clinical research certificate. She is passionate abut advancing clinical research and improving patient outcomes.
Sessions
Smith+Nephew: Unlocking Our Full Potential: Cross-functional Collaboration to Drive Innovation and Business Readiness
With over 17 years of experience in life sciences, Greg leads a team of IT experts focused on business partnering, innovation, and solution delivery for clinical and medical affairs. He joined Smith+Nephew in 2021 after holding leadership roles in R&D technology across the pharmaceutical and software industries.
Sessions
Smith+Nephew: Unlocking Our Full Potential: Cross-functional Collaboration to Drive Innovation and Business Readiness
Wednesday, 6 November
12:30 CET
Greg Skelton
Director, Clinical Systems
Smith+Nephew
Elemed, Philips: Upskilling Regulatory and Quality Teams to Meet Evolving Needs
With a surge in regulatory activity, quality and regulatory teams must constantly develop new skills to handle the ever-changing global environment. Join this session and learn how Elemed and Philips upskill their teams to maintain compliance for their existing portfolio, get new products to market, and support digital transformation.
Leo Louis
Director, Regulatory Affairs
Philips
Leo has more than 18 years experience in quality, regulatory, and compliance roles and currently leads Regulatory Affairs for MRI Systems at Philips. Previously he has worked with GE, Stryker, Thermo Fisher, and UL Inc. in various quality and regulatory roles, as well as playing a pivotal role in various medtech start-ups to bring new innovations to market. Leo is also a member of RAPS and its Euroconvergence planning committee.
Sessions
Elemed, Philips: Upskilling Regulatory and Quality Teams to Meet Evolving Needs
Wednesday, 6 November
12:30 CET
Leo Louis
Director, Regulatory Affairs
Philips
Elena Kyria
CEO
Elemed
Elena is an award-winning talent acquisition specialist. She helps top QA/RA professionals connect with leading companies and coaches others on building strong personal brands. Elena hosts the "Career Diaries in MedTech" podcast and manages the EU MDR/IVDR update forum with over 10,000 members. She also serves on the RAPS Swiss chapter management team.
Sessions
Elemed, Philips: Upskilling Regulatory and Quality Teams to Meet Evolving Needs
Wednesday, 6 November
12:30 CET
Elena Kyria
CEO
Elemed
Johnson & Johnson: Adapting Global Marketing Assets for Local Success
Learn how Johnson & Johnson streamlines marketing content with a global-to-local approach. Dive into their journey of creating a unified process for assets and claims, localization tactics, and effective change management techniques.
Stephanie Carter
Associate Director, Promotional Integrity
Johnson & Johnson MedTech - Vision
Stephanie is Senior Manager Global Marketing Innovation at Johnson & Johnson where she manages the copy approval process for J&J MedTech Vision across all regions. She is also the Vault PromoMats owner. Stephanie has 15 years experience in the Pharmaceutical and MedTech sectors.
Sessions
Johnson & Johnson: Adapting Global Marketing Assets for Local Success
Wednesday, 6 November
12:30 CET
Stephanie Carter
Associate Director, Promotional Integrity
Johnson & Johnson MedTech - Vision
BD: Designing a Modern Approach to Medical Content and Inquiry Management
Learn how BD transformed their process for managing medical content and inquiries into a modern, digital approach. Understand what led to the decision, how the team rallied behind a common objective, and hear tips to operationalize in your organization.
Cassie Singleton
Director, Medical Information
BD
As the Director of Medical Information at BD, Cassie manages the team responsible for addressing customer inquiries regarding BD products and the procedures in which they are used. Her team utilizes Vault Medical globally to provide consistent, approved responses to customers while providing valuable insights back to the business.
Sessions
BD: Designing a Modern Approach to Medical Content and Inquiry Management
Wednesday, 6 November
12:30 CET
Cassie Singleton
Director, Medical Information
BD
13:15 — 14:10
CET
Networking Lunch
14:15 — 15:00
CET
Accelerating Product Development Using Technology to Bridge a Hybrid Operating Model
Establishing a clinical business case to support a hybrid operating model of insourced and outsourced clinical trial management requires careful planning. Learn how Radiometer has accelerated product development by building a hybrid operating model using Vault eTMF and CTMS.
Kevin Valle Lozano
Sr. Clinical Project Manager
Radiometer
With over 10 years of experience in clinical development across pharma and medical devices, Kevin combines a background in genetics, genomics, and an MBA in pharmaceutical industries. He now leads Radiometer’s clinical digital transformation, driven by a passion for innovation and improving patient outcomes. Kevin excels in process redesign and system implementation, leading global teams to prioritize safety, quality, and efficiency in clinical operations.
Sessions
Accelerating Product Development Using Technology to Bridge a Hybrid Operating Model
Coloplast, Smith+Nephew: Regulatory Intelligence: From Information Overload to Strategic Decision Making
Coloplast and Smith+Nephew will explain how they established regulatory intelligence programs to make strategic decisions about product development, cut through the noise, alleviate administrative burden, and set up sustainable long-term processes.
Benjamin Rochette
Vice President, Global Regulatory Affairs
Coloplast
Benjamin has more than 17 years experience in the medical device industry. Since joining Coloplast in 2020, he has been dedicated to ensuring that the regulatory affairs function efficiently supports the company’s innovation and growth. He leads Regulatory Affairs to ensure timely market entry for new products, sustained lifecycle management, and compliance with global regulations. Benjamin has held regulatory affairs roles in start-ups, SMEs, and multinational companies, working on projects across a wide array of medical specialties and healthcare technologies. He also teaches at the university level aiming to inspire future RA professionals.
Sessions
Coloplast, Smith+Nephew: Regulatory Intelligence: From Information Overload to Strategic Decision Making
Wednesday, 6 November
14:15 CET
Coloplast & GE Healthcare: The Future of Medtech Innovation in Europe
Thursday, 7 November
11:20 CET
Benjamin Rochette
Vice President, Global Regulatory Affairs
Coloplast
Darren Thain
RA Director, Global Regulatory Intelligence and Policy
Smith+Nephew
With 10+ years experience in various regulatory and quality roles, Darren is currently responsible for regulatory affairs for global policy and intelligence across all franchises at Smith+Nephew. He previously held roles with small and large organizations in medical device, pharmaceutical, and animal materials covering various product technologies. Darren also served as Director of European Regulatory Affairs and Commercial Quality and was EU MDR Regulatory lead for the Wound franchise within Smith+Nephew.
Sessions
Coloplast, Smith+Nephew: Regulatory Intelligence: From Information Overload to Strategic Decision Making
Wednesday, 6 November
14:15 CET
Darren Thain
RA Director, Global Regulatory Intelligence and Policy
Smith+Nephew
Vault QMS Product Roadmap
See the latest Vault QMS innovations streamlining critical quality processes, including complaint handling, audits, and risk management.
Prannoy Kothari
Principal Product Manager, VPS, QRM, and MedTech Quality
Veeva
Sessions
Vault QMS Product Roadmap
Wednesday, 6 November
14:15 CET
Vault QualityDocs & Vault Training Product Roadmap
Thursday, 7 November
9:00 CET
Prannoy Kothari
Principal Product Manager, VPS, QRM, and MedTech Quality
Veeva
Commercial Content Product Roadmap
See the latest Vault PromoMats content innovations to simplify the user experience, increase speed, and enable reuse with modular content.
Jeff Gorski
Senior Director, Commercial Content Strategy
Veeva MedTech
Sessions
Commercial Content Product Roadmap
Wednesday, 6 November
14:15 CET
Veeva Medical Suite: Art of the Possible
Wednesday, 6 November
14:15 CET
Jeff Gorski
Senior Director, Commercial Content Strategy
Veeva MedTech
Getting the Most Out of Reports & Dashboards
Improve your organization's visibility into operational processes, application usage, and KPIs with Vault reports and dashboards. Learn about Vault reporting's core tools and how to use them to convert an idea for a metric into an actionable dashboard.
Amee Patel
Solution Consultant
Veeva
Sessions
Getting the Most Out of Reports & Dashboards
Wednesday, 6 November
14:15 CET
Amee Patel
Solution Consultant
Veeva
Veeva Medical Suite: Art of the Possible
In this overview of the Veeva Medical Suite we'll share how the applications work together, connecting software and data to scale medical affairs.
Gea Ballmann
Principal Solution Consultant, Commercial
Veeva
Sessions
Veeva Medical Suite: Art of the Possible
Wednesday, 6 November
14:15 CET
Gea Ballmann
Principal Solution Consultant, Commercial
Veeva
Jeff Gorski
Senior Director, Commercial Content Strategy
Veeva MedTech
Sessions
Commercial Content Product Roadmap
Wednesday, 6 November
14:15 CET
Veeva Medical Suite: Art of the Possible
Wednesday, 6 November
14:15 CET
Jeff Gorski
Senior Director, Commercial Content Strategy
Veeva MedTech
15:15 — 16:00
CET
End-to-End Demo: Simplifying and Standardizing Clinical Investigations
See Veeva's vision for a unified clinical ecosystem through an end-to-end demo spanning patients, sites, and sponsors/CROs. This live demo showcases what is available today with Vault Clinical Operations, Image Management in Vault EDC, Veeva eCOA and Veeva CDB.
Vault RIM Product Roadmap
Hear about the most recent and upcoming Vault RIM features across Registrations, Submissions, Publishing, and Archive, as well as a detailed roadmap for optimizing the overall Vault RIM experience.
Kelly Finlan-Dansbury
Senior Product Manager, Vault Registrations
Veeva
Sessions
Vault RIM Product Roadmap
Wednesday, 6 November
15:15 CET
Kelly Finlan-Dansbury
Senior Product Manager, Vault Registrations
Veeva
Determining Best Practices for Risk-based Testing and Validation
Computer Software Assurance (CSA) and GAMP 5 provide device manufacturers with a robust framework for implementing risk-based methodologies, ensuring the consistent production of high-quality devices. Join regulators and industry experts to discover how technology, processes, and people collaborate to support and enhance risk-based validation.
David Hohler
Sr. Director, Global Technology Solutions
Glaukos
Dave leads the global technology solution transformations team at Glaukos. He works to align business and technology needs to meet growing organizational requirements, focusing on nimble and effective solutions
Sessions
Glaukos: Bridging the Gap Between Business and IT
Wednesday, 6 November
11:30 CET
Determining Best Practices for Risk-based Testing and Validation
Wednesday, 6 November
15:15 CET
David Hohler
Sr. Director, Global Technology Solutions
Glaukos
Dr. Hayden Atkinson
Global Enterprise Systems Compliance Manager
CooperVision
Hayden Atkinson has a background in systems engineering and has been with CooperVision for 23 years, working in several different departments, from R&D to Regulatory and Quality. He is currently responsible for the compliance of all the global systems CooperVision utilizes.
Sessions
Determining Best Practices for Risk-based Testing and Validation
Wednesday, 6 November
15:15 CET
Dr. Hayden Atkinson
Global Enterprise Systems Compliance Manager
CooperVision
Streamlining MLR to Mitigate Risk and Ensure Compliance
BD senior compliance leaders shares insights on the complexities of regulatory compliance in medtech content and dissemination including key requirements and best practices for MLR review to mitigate risk and enhance efficiency.
Andrea Negrete
Regulatory Affairs Specialist
BD
As Regulatory Affairs Specialist at BD for the EMEA region, Andrea is responsible for review and approval of promotional material launches. She also trains different stakeholders and supports the implementation and harmonization of tools that facilitate the approval process.
Sessions
Streamlining MLR to Mitigate Risk and Ensure Compliance
Wednesday, 6 November
15:15 CET
Andrea Negrete
Regulatory Affairs Specialist
BD
Alice Morel
Regulatory Affairs Manager
BD
With 10 years of experience in regulatory affairs for the pharmaceutical and medtech sectors, Alice currently serves as Regulatory Affairs Manager for the EMEA region at BD. Her primary focus is on the promotional review and approval process in this region. She has successfully established several multidisciplinary working groups, collaborating with global, regional, and local leaders to develop tools that streamline the material approval workflow. Her goal is to ensure efficiency while maintaining compliance with local regulations.
Sessions
Streamlining MLR to Mitigate Risk and Ensure Compliance
Wednesday, 6 November
15:15 CET
Alice Morel
Regulatory Affairs Manager
BD
Vault Platform Technical Architecture
Learn how the Vault Platform is evolving to support medtech customers across all domains. We'll review recent highlights around user productivity and scalability along with cross-functional connections to maximize value.
Jocelyn Trisic
Product Manager
Veeva
Sessions
Vault Platform Technical Architecture
Wednesday, 6 November
15:15 CET
Jocelyn Trisic
Product Manager
Veeva
GE: Connecting the Medical Affairs Ecosystem
Discover the importance of a connected ecosystem in medical affairs and explore development through integrating people, process, and technology for enhanced collaboration, compliance, and patient outcomes.
Elaine Long, PhD
Director of Strategic R&D Alliances
GE HealthCare
Elaine joined GE Healthcare in 2020 as Director of Strategic R&D Alliances to support research collaborations for a growing pipeline of molecular imaging diagnostics, aligning internal stakeholders and research sites. She has 15 years of clinical experience and holds a PhD in Molecular Immunology.
Sessions
GE: Connecting the Medical Affairs Ecosystem
Wednesday, 6 November
15:15 CET
Elaine Long, PhD
Director of Strategic R&D Alliances
GE HealthCare
Sascha Rode-Kluge
Medical Director, Germany
GE HealthCare
Formerly a medical science liaison in oncology and inflammation at Amgen and Alnylam, Sascha has a strong background in launching therapeutic products, organizing medical events, and supporting compassionate use programs. His expertise spans gastroenterology, rheumatology, neurology, radiology, and nuclear medicine, with a proven ability in communication and stakeholder engagement.
Sessions
GE: Connecting the Medical Affairs Ecosystem
Wednesday, 6 November
15:15 CET
Sascha Rode-Kluge
Medical Director, Germany
GE HealthCare
16:00 — 16:30
CET
Connect Break / Refreshments
16:30 — 17:00
CET
Change Management and Transformation: Learn from our Heroes
Our 2024 Heroes will discuss how they championed change within their organizations, including common challenges, priorities, key elements of successful transformation, and lessons learned.
Hear from industry leaders who are at various points of their clinical customer journey. Alcon, Terumo, and Radiometer will provide their insight on a variety of topics during this interactive session with the audience.
Marie-Pierre Dewez
Clinical Affairs Director EMEA
Terumo Europe NV
Marie-Pierre has over 30 years of experience in clinical research across pharma and medical devices, including leading roles at Volcano/Philips, Boston Scientific, Cordis J&J, and Bristol-Myers Squibb. Her adaptability, proactive problem-solving skills, deep understanding of evolving industry dynamics, and ability to work with diverse, cross-functional teams have contributed to her success in complex, global environments.
Sessions
Terumo, BSI, Q-Serve: The Impact of MDR and IVDR on Clinical Evidence Generation
With over 15 years experience leading global teams in operations, data management, and systems, Leianne is an established leader in clinical research. As head of data management at Alcon, she is also the business lead for the Veeva Vault CDMS implementation.
Sessions
Alcon: Connecting Patients, Sites, and Sponsors with a Unified Clinical Platform
With over 10 years of experience in clinical development across pharma and medical devices, Kevin combines a background in genetics, genomics, and an MBA in pharmaceutical industries. He now leads Radiometer’s clinical digital transformation, driven by a passion for innovation and improving patient outcomes. Kevin excels in process redesign and system implementation, leading global teams to prioritize safety, quality, and efficiency in clinical operations.
Sessions
Accelerating Product Development Using Technology to Bridge a Hybrid Operating Model
Betsy leads the global team supporting clinical studies and oversees eTMF operations at Smith+Nephew. She has a strong background in nursing and clinical research and holds a master’s in nursing and a clinical research certificate. She is passionate abut advancing clinical research and improving patient outcomes.
Sessions
Smith+Nephew: Unlocking Our Full Potential: Cross-functional Collaboration to Drive Innovation and Business Readiness
ABHI, MedTech Europe, SGS: Preparing for Electronic Submissions
Join a panel discussion on the future of electronic submissions and regulatory convergence in Europe. The notified body SGS will provide best practices for technical file submissions to maximize the chances of success. In addition, ABHI and MedTech Europe will share perspectives on topics like IMDRF and other ongoing efforts to remove bureaucratic tasks and shift the focus back to technical and clinical reviews.
Stephen Lee
Director, Diagnostics and Digital Regulation
ABHI
A trained biomedical scientist, with degress in biochemistry and biology, Steve worked in hospital microbiology before moving to industry. Prior to his current role at ABHI, he held positions at MHRA working with manufacturers, notified bodies, trade associations, and government departments, and chaired the European Commissions's IVD working group. In 2019, Steve received the TOPRA award for regulatory excellence.
Sessions
ABHI, MedTech Europe, SGS: Preparing for Electronic Submissions
Thursday, 7 November
9:00 CET
Stephen Lee
Director, Diagnostics and Digital Regulation
ABHI
Diana Kanecka
Director International Affairs
MedTech Europe
Diana leads MedTech Europe's International Affairs activities, concentrating on promoting regulatory convergence and overcoming barriers to access medical technologies. With extensive experience in European Medical Devices and IVD regulations and trade policy, she is dedicated to advancing access to medical technologies.
Sessions
ABHI, MedTech Europe, SGS: Preparing for Electronic Submissions
Thursday, 7 November
9:00 CET
Diana Kanecka
Director International Affairs
MedTech Europe
Mark Baylis
Soft Tissue Team Manager
SGS
Mark is a biomedical engineer with 14 years of experience in the medical device industry, mostly working in R&D, manufacturing, and regulatory affairs with class III cardiovascular devices. He also has 7 years of experience working as a product assessor in notified bodies.
Sessions
ABHI, MedTech Europe, SGS: Preparing for Electronic Submissions
Thursday, 7 November
9:00 CET
Mark Baylis
Soft Tissue Team Manager
SGS
Vault QualityDocs & Vault Training Product Roadmap
See the latest Vault QualityDocs and Vault Training innovations to enhance collaboration, compliance, and efficiency for document and learning management processes.
Prannoy Kothari
Principal Product Manager, VPS, QRM, and MedTech Quality
Veeva
Sessions
Vault QMS Product Roadmap
Wednesday, 6 November
14:15 CET
Vault QualityDocs & Vault Training Product Roadmap
Thursday, 7 November
9:00 CET
Prannoy Kothari
Principal Product Manager, VPS, QRM, and MedTech Quality
Veeva
ZEISS: Powering AI Applications with a Vault Foundation
As the industry uncovers new ways to utilize AI technology, Veeva is committed to ensuring that Vault supports customer-built data models. Learn how ZEISS unlocked additional value with Vault PromoMats by building an AI application on top of it to improve regulated content management.
Dr. Jochen Tham
Head of Digital Customer Experience
ZEISS Medical Technology
Focus on the customer experience within the scientific and medical market space. Multiple positions in Germany and the US in sales, marketing, and communication in ZEISS Microscopy and Medical technology segment. Building understanding to adapt Marketing technology to special requirements of a regulated market and in the moment driving the transformation to data-driven, platform-based engagement to create a differentiating digital customer experience.
Sessions
GE, Philips, ZEISS: Fueling Data-driven Marketing with Organizational Change
Wednesday, 6 November
10:00 CET
ZEISS: Powering AI Applications with a Vault Foundation
Thursday, 7 November
9:00 CET
Dr. Jochen Tham
Head of Digital Customer Experience
ZEISS Medical Technology
10:00 — 10:45
CET
Vault Clinical Product Roadmap
The Vault Clinical Operations team will cover recent releases and new features planned for the upcoming year for the clinical operations platform. Learn about new features across eTMF, CTMS, Payments, and Site Connect.
Florent Lusardi
Senior Product Expert, Clinical Operations
Veeva
Sessions
Vault Clinical Product Roadmap
Thursday, 7 November
10:00 CET
Florent Lusardi
Senior Product Expert, Clinical Operations
Veeva
Jess Mannion
MedTech Clinical Community Manager
Veeva
Sessions
Vault Clinical Product Roadmap
Thursday, 7 November
10:00 CET
Jess Mannion
MedTech Clinical Community Manager
Veeva
Intuitive: Building the Business Case for Regulatory Transformation
Intuitive will share how they're investing in the future of regulatory affairs by gathering intel from regulators, looking beyond immediate needs, and creating more efficient, scalable processes. They'll also cover key steps to building a business case with a RIM foundation that connects the dots to other crucial areas like eQMS, CAPA, and complaints to form a broader ecosystem.
Romain Denis
Vice President Global Regulatory Affairs and International RAQA
Intuitive Surgical
With over 20 years in regulatory, quality, and clinical roles in both medical device and pharmaceutical technology, Romain has deep technical knowledge and regulatory expertise across drug delivery devices, orthopedics, cardiac devices, wound care, surgical products, and robotic surgery. A Bio Mechanical Engineer with an executive MBA in Quality and Regulatory Management, he is focused on a results oriented approach and collaboration between leaders, external authorities, and regulators.
Sessions
Intuitive: Building the Business Case for Regulatory Transformation
Thursday, 7 November
10:00 CET
Romain Denis
Vice President Global Regulatory Affairs and International RAQA
Intuitive Surgical
Post Market Surveillance Trends
Post Market Surveillance planning and reporting has emerged as a new area of opportunity towards assurance of patient safety and ongoing effectiveness of products. In this session, our panelists will discuss the trends driving new requirements in post market surveillance, and how organizations can setup effective PMS planning and reporting programs.
Emiliano D'Urso
PMS & Regulatory Intelligence Manager
TOSOH Europe NV
As an expert in post market surveillance (PMS) and vigilance within the IVD industry, Emiliano serves as Chair of the MedTech Europe PMSV IVD Working Group, actively shaping regulatory frameworks across Europe.
Sessions
Post Market Surveillance Trends
Thursday, 7 November
10:00 CET
Emiliano D'Urso
PMS & Regulatory Intelligence Manager
TOSOH Europe NV
Content Metrics Blueprint
Establish the groundwork for better content performance and marketing ROI by understanding the foundational concepts on metrics, measurement, and content optimization. We will explore metrics across content operations, utilization, and engagement.
Pearl Vyas
Engagement Manager, MedTech Business Consulting
Veeva
Sessions
Content Metrics Blueprint
Thursday, 7 November
10:00 CET
Pearl Vyas
Engagement Manager, MedTech Business Consulting
Veeva
Mila Heil
Engagement Manager, MedTech Business Consulting
Veeva
Sessions
Content Metrics Blueprint
Thursday, 7 November
10:00 CET
Mila Heil
Engagement Manager, MedTech Business Consulting
Veeva
Medical Affairs Transformation: It's a Journey
Explore the transformative journey of medical affairs in MedTech, focusing on innovation, regulatory alignment and strategies to enhance patient safety and outcomes.
Christoph Bug
VP Global Medical
Veeva
Christoph Bug is responsible for Veeva’s global medical strategy, working to connect medical affairs more closely with key stakeholders. He previously spent over a decade at Janssen Pharmaceutical Companies of Johnson & Johnson where he was most recently the country medical and scientific lead and managing director for Germany. Earlier Christoph served as director of global market access innovation for Johnson & Johnson R&D in the U.S., business unit director in France and Germany, and director of health economics in EMEA.
Christoph earned his International MBA from IE Business School in Spain and his MD and PhD in medicine at Goethe University in Germany.
Sessions
Medical Affairs Transformation: It's a Journey
Thursday, 7 November
10:00 CET
Christoph Bug
VP Global Medical
Veeva
10:45 — 11:15
CET
Connect Break / Refreshments
11:20 — 12:00
CET
Coloplast & GE Healthcare: The Future of Medtech Innovation in Europe
What we as an industry can do to stimulate innovation and get life-changing products to patients faster. Panelists will share insights and experiences on how to drive innovation.
Benjamin Rochette
Vice President, Global Regulatory Affairs
Coloplast
Benjamin has more than 17 years experience in the medical device industry. Since joining Coloplast in 2020, he has been dedicated to ensuring that the regulatory affairs function efficiently supports the company’s innovation and growth. He leads Regulatory Affairs to ensure timely market entry for new products, sustained lifecycle management, and compliance with global regulations. Benjamin has held regulatory affairs roles in start-ups, SMEs, and multinational companies, working on projects across a wide array of medical specialties and healthcare technologies. He also teaches at the university level aiming to inspire future RA professionals.
Sessions
Coloplast, Smith+Nephew: Regulatory Intelligence: From Information Overload to Strategic Decision Making
Wednesday, 6 November
14:15 CET
Coloplast & GE Healthcare: The Future of Medtech Innovation in Europe
Thursday, 7 November
11:20 CET
Benjamin Rochette
Vice President, Global Regulatory Affairs
Coloplast
Friederike von Krosigk
CSMO International
GE HealthCare
Friederike has over 20 years of experience in marketing, sales, and strategy roles across FMCG (Mondelez, Mars), Medical Devices (J&J), Pharma (Merck), and Medtech (GE). She has led customer-centric transformations, executed omnichannel strategies, and driven brand and lead generation campaigns resulting in significant business growth and enhanced sales performance.
Sessions
GE, Philips, ZEISS: Fueling Data-driven Marketing with Organizational Change
Wednesday, 6 November
10:00 CET
Coloplast & GE Healthcare: The Future of Medtech Innovation in Europe
Thursday, 7 November
11:20 CET
Friederike von Krosigk
CSMO International
GE HealthCare
12:00 — 13:00
CET
Networking Lunch
13:00 — 15:00
CET
Vault Clinical Community Meeting
Collaborate with your peers and Veeva experts during an open discussion on clinical best practices and how to leverage Vault Clinical applications to drive efficiency. You'll have the opportunity to share approaches and learn how your peers are leveraging Vault. We'll also dive into the latest features.
Vault RIM Community Meeting
Collaborate with your peers and Veeva experts during an open discussion on regulatory best practices and how to leverage Vault RIM applications to drive efficiency and compliance. You'll have the opportunity to share approaches and learn how your peers are leveraging Vault. We'll also dive into the latest features.
Vault Quality Community Meeting
Collaborate with your peers and Veeva experts during an open discussion on quality best practices and how to leverage Vault applications to drive efficiency and safety. You'll have the opportunity to share approaches and learn how your peers are leveraging Vault. We'll also dive into the latest features of Vault Quality Platform.
Vault Commercial Content Community Meeting
Collaborate with your peers and Veeva experts during an open discussion on commercial and claims management best practices and how to leverage Vault applications to drive efficiency, compliance, and speed to market. You'll have the opportunity to share approaches and learn how your peers are leveraging Vault. We'll also dive into the latest features.
Vault Medical Affairs Community Meeting
Collaborate with your peers and Veeva experts during an open discussion on medical affairs best practices and how to leverage Vault Medical applications to drive efficiency. You'll have the opportunity to share approaches and learn how your peers are leveraging Vault. We'll also dive into the latest features.
