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Tue, May 5
Wed, May 6
Thu, May 7
Fri, May 8
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Tuesday, May 5, 2026
07:30 - 18:00
WEST
Registration Hours
07:30 - 18:00
WEST
Registration Hours
08:00 - 12:00
WEST
RAPS General Assembly + RAPS European Council Meeting (REC)
08:00 - 12:00
WEST
RAPS General Assembly + RAPS European Council Meeting (REC)
Facilitator:
Kim Young, MSc (she/her/hers)
– RAPS
08:30 - 16:00
WEST
Pre-Conference Workshop: Building Global CDx Studies: Strategic Planning Tools for IVD and Pharma Partners
08:30 - 16:00
WEST
Pre-Conference Workshop: Building Global CDx Studies: Strategic Planning Tools for IVD and Pharma Partners
Presenter:
Natalie Batty, MPH
– Aignostics
Presenter:
Marina Belonogova, PhD (she/her/hers)
– Johnson & Johnson
Presenter:
Carlos Galamba, MSc
– MDx CRO
Presenter:
Kristiane Schmidt, PhD (she/her/hers)
– Qserve Consultancy
Pre-Conference Workshop
IVD's
08:30 - 16:00
WEST
Pre-Conference Workshop: Driving Change: How to Successfully Implement AI and Digital Transformation in Regulatory Affairs (MD, Pharma, IVDR)
08:30 - 16:00
WEST
Pre-Conference Workshop: Driving Change: How to Successfully Implement AI and Digital Transformation in Regulatory Affairs (MD, Pharma, IVDR)
Workshop Leader:
Florian Tolkmitt
– PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter:
Sarah Haake-Schäfer
– Carl Zeiss Vision International GmbH
Presenter:
Erika Schuettfort, PhD (she/her/hers)
– Vorsa
Pre-Conference Workshop
Digital Health
Pharmaceuticals
Medical Devices
08:30 - 16:00
WEST
Pre-Conference Workshop: EUDAMED: Practical Implementation to Date, Strategic Insights and Future Modules
08:30 - 16:00
WEST
Pre-Conference Workshop: EUDAMED: Practical Implementation to Date, Strategic Insights and Future Modules
Workshop Leader:
Marina Madokoro (she/her/hers)
– Johnson & Johnson
Presenter:
Jay K. Katta
– BSI
Presenter:
Christoph Kiesselbach (he/him/his)
– Schrack & Partner
Presenter:
Sofia Palm, MSc
– BSI
Speaker:
Susanne Wydenkeller Hinder
Pre-Conference Workshop
Medical Devices
08:30 - 16:00
WEST
Pre-Conference Workshop: Global Regulatory Pathways - US, China and South Korea
08:30 - 16:00
WEST
Pre-Conference Workshop: Global Regulatory Pathways - US, China and South Korea
Workshop Leader:
Chang-Hong Whitney, RAC, MBA
– Whitney Consulting Ltd.
Presenter:
M. Jason Brooke, MSE, JD, CSQE
– Brooke & Associates
Presenter:
Young Kim, MBA
– Synex Consulting Ltd.
Pre-Conference Workshop
Medical Devices
08:30 - 16:00
WEST
Pre-Conference Workshop: Technical Documentation Assessment of MDSW-a Notified Body Perspective
08:30 - 16:00
WEST
Pre-Conference Workshop: Technical Documentation Assessment of MDSW-a Notified Body Perspective
Workshop Leader:
Marta Carnielli
– TUV Sud Product Service GmbH
Presenter:
Marco Caproni (he/him/his)
– TÜV SÜD
Presenter:
Gaëlle Bisch
– GMED, France
Presenter:
Thomas Doerge
– BSI BV
Pre-Conference Workshop
Digital Health
08:30 - 16:00
WEST
Pre-Conference Workshop:International Collaborative Initiatives
08:30 - 16:00
WEST
Pre-Conference Workshop: International Collaborative Initiatives
Pre-Conference Workshop
Pharmaceuticals
10:30 - 11:00
WEST
Preconference Workshops: Networking Break
10:30 - 11:00
WEST
Preconference Workshops: Networking Break
13:00 - 14:00
WEST
Preconference Workshops: Networking Lunch
13:00 - 14:00
WEST
Preconference Workshops: Networking Lunch
13:00 - 16:00
WEST
RAPS Volunteer Leader Summit
13:00 - 16:00
WEST
RAPS Volunteer Leader Summit
15:00 - 16:00
WEST
RAPS Career Development Session for Students
15:00 - 16:00
WEST
RAPS Career Development Session for Students
Session Leader:
Kim Young, MSc (she/her/hers)
– RAPS
16:00 - 16:30
WEST
Preconference Workshops: Afternoon Break
16:00 - 16:30
WEST
Preconference Workshops: Afternoon Break
16:30 - 18:30
WEST
Euro Convergence 2026: Welcome and Opening Plenary
16:30 - 18:30
WEST
Euro Convergence 2026: Welcome and Opening Plenary
18:30 - 19:30
WEST
Opening Reception in Exhibition Hall
18:30 - 19:30
WEST
Opening Reception in Exhibition Hall
Wednesday, May 6, 2026
07:30 - 18:00
WEST
Registration Hours
07:30 - 18:00
WEST
Registration Hours
08:30 - 09:30
WEST
AI Tools
08:30 - 09:30
WEST
AI Tools
Pharmaceuticals
08:30 - 09:30
WEST
Cybersecurity
08:30 - 09:30
WEST
Cybersecurity
Speaker:
Oscar Freyer (he/him/his)
– Else Kröner Fresenius Center for Digital Health,TUD Dresden University of Technology
Speaker:
Max Ostermann
– EKFZ for Digital Health, TUD Dresden University of Technology
Speaker:
Brandi Conardy, MA
– Bausch + Lomb
Digital Health
08:30 - 09:30
WEST
MDR 2.0: Kick-off Panel 2026
08:30 - 09:30
WEST
MDR 2.0: Kick-off Panel 2026
Moderator:
Gert BQ Bos, MSc, PhD, FRAPS
– Qserve Group
Moderator:
Sabina L. Hoekstra, PharmD FRAPS
– TUV SUD
Medical Devices
08:30 - 09:30
WEST
New Pharma Legislation: Part 1
08:30 - 09:30
WEST
New Pharma Legislation: Part 1
Pharmaceuticals
08:30 - 09:30
WEST
QMSR: Navigating the New FDA Quality Management System Regulation (QMSR): Regulatory Insights and Compliance Strategies
08:30 - 09:30
WEST
QMSR: Navigating the New FDA Quality Management System Regulation (QMSR): Regulatory Insights and Compliance Strategies
Speaker:
Seb Clerkin, RAC (EU)
– GMP Advisory Services
Medical Devices
08:30 - 09:30
WEST
Transitional Timelines Unpacked: EU 2024/1860 and Its Impact on Legacy IVDs
08:30 - 09:30
WEST
Transitional Timelines Unpacked: EU 2024/1860 and Its Impact on Legacy IVDs
Speaker:
Sara Fabi
– BSI group
IVD's
09:30 - 10:45
WEST
Presenters at Posters (Exhibition Hall)
09:30 - 10:45
WEST
Presenters at Posters (Exhibition Hall)
09:30 - 10:45
WEST
Refreshment Break in the Exhibit Hall
09:30 - 10:45
WEST
Refreshment Break in the Exhibit Hall
09:40 - 10:10
WEST
Solutions Circle: Building Foundational Skills for Regulators in the Age of Artificial Intelligence
09:40 - 10:10
WEST
Solutions Circle: Building Foundational Skills for Regulators in the Age of Artificial Intelligence
Facilitator:
Katy Slater
– Komorebi Ltd
Solutions Circle
09:40 - 10:10
WEST
Solutions Circle: Early Market Access to Innovative Diagnostics
09:40 - 10:10
WEST
Solutions Circle: Early Market Access to Innovative Diagnostics
Facilitator:
Nadine Neale
– Medicines and Healthcare Products Regulatory Agency
Solutions Circle
09:40 - 10:10
WEST
Solutions Circle: Is Consent the Answer? Exploring Regulatory Options for Non-Compliant Devices in Australia
09:40 - 10:10
WEST
Solutions Circle: Is Consent the Answer? Exploring Regulatory Options for Non-Compliant Devices in Australia
Facilitator:
Kea Dent, MBA, GAICD, RAC (she/her/hers)
– KD&A
Solutions Circle
09:40 - 10:10
WEST
Solutions Circle: Was SoHO Born From HCT/Ps?
09:40 - 10:10
WEST
Solutions Circle: Was SoHO Born From HCT/Ps?
Facilitator:
Mark Levi, PhD
– RTI
Solutions Circle
09:45 - 10:10
WEST
Sponsored Presentations: Round 1
09:45 - 10:10
WEST
Sponsored Presentations: Round 1
Sponsored Presentation
10:15 - 10:40
WEST
Sponsored Presentations: Round 2
10:15 - 10:40
WEST
Sponsored Presentations: Round 2
Sponsored Presentation
10:15 - 10:45
WEST
Solutions Circle: RCC Informational Roundtable
10:15 - 10:45
WEST
Solutions Circle: RCC Informational Roundtable
Facilitator:
Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE
– RAPS
Solutions Circle
10:15 - 10:45
WEST
Solutions Circle: Regulators Are Using AI — Is Your Submission Ready to Be Reviewed by One?
10:15 - 10:45
WEST
Solutions Circle: Regulators Are Using AI — Is Your Submission Ready to Be Reviewed by One?
Facilitator:
Josh Kim
– Artos AI
Solutions Circle
10:15 - 10:45
WEST
Solutions Circle: Up, Close and Practical with the European Health Data Space
10:15 - 10:45
WEST
Solutions Circle: Up, Close and Practical with the European Health Data Space
Facilitator:
Cecile E. van der Heijden (she/her/hers)
– Axon Lawyers
Solutions Circle
10:15 - 10:45
WEST
Solutions Circle: Updates on the Battery Regulation (EU) 2023/1542 and Their Impact on Medical Devices
10:15 - 10:45
WEST
Solutions Circle: Updates on the Battery Regulation (EU) 2023/1542 and Their Impact on Medical Devices
Facilitator:
Christoph Kiesselbach (he/him/his)
– Schrack & Partner
Solutions Circle
10:45 - 11:45
WEST
AI Tooling for regulated processes
10:45 - 11:45
WEST
AI Tooling for Regulated Processes
Digital Health
10:45 - 11:45
WEST
Building IVDR Technical Files Early-Phase Insights and Strategic Approaches
10:45 - 11:45
WEST
Building IVDR Technical Files: Early-Phase Insights and Strategic Approaches
Speaker:
Ellen van Loon, PhD
– DEKRA Certification B.V.
IVD's
10:45 - 11:45
WEST
Deregulation/Centralization
10:45 - 11:45
WEST
Deregulation/Centralization
Medical Devices
10:45 - 11:45
WEST
MDSAP
10:45 - 11:45
WEST
MDSAP
Speaker:
Grace F. Palma, MBA (she/her/hers)
– China Med Device
Speaker:
Ed Ball, CEng MIPEM (he/him/his)
– RQM+
Speaker:
Linda Moon, MPhil., BSc.(Hons). (she/her/hers)
– BSI
Medical Devices
10:45 - 11:45
WEST
New Pharma Legislation: Part 2
10:45 - 11:45
WEST
New Pharma Legislation: Part 2
Moderator:
Rebecca Lumsden, PhD (she/her/hers)
– Sanofi
Speaker:
Yves Jacob (he/him/his)
– Sanofi
Pharmaceuticals
10:45 - 11:45
WEST
Strategy & Funding: Rise of Regulatory as a Business Driver
10:45 - 11:45
WEST
Strategy & Funding: Rise of Regulatory as a Business Driver
Speaker:
Melissa Finocchio, ASQ CQE, ASQ CRE (she/her/hers)
– Proud Lion Services
Business; Pharma
12:00 - 13:00
WEST
Are CE-marked AI ‘Configurable Platforms’ the Future and What Are Their Legal and Regulatory Bounds?
12:00 - 13:00
WEST
Are CE-marked AI ‘Configurable Platforms’ the Future and What Are Their Legal and Regulatory Bounds?
Speaker:
Stephen Gilbert, PhD (he/him/his)
– Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Speaker:
Erik R. Vollebregt
– Axon Lawyers
Digital Health
12:00 - 13:00
WEST
Clinical Evaluation
12:00 - 13:00
WEST
Clinical Evaluation
Speaker:
Natascha J. Cuper
– Kiwa Assurance
Speaker:
Leon J. Doorn, M.Sc. (he/him/his)
– MedQAIR
Speaker:
Matthew Kirkman, MBBS FEBNS PhD
– TÜV SÜD
Medical Devices
12:00 - 13:00
WEST
Combined CTR+IVDR Trials
12:00 - 13:00
WEST
Combined CTR+IVDR Trials
Speaker:
Carlos Galamba, MSc
– MDx CRO
Speaker:
Kirsten Van Garsse, RCC (she/her/hers)
– QbD Group
Speaker:
Piritta M. Maunu, MSc (she/her/hers)
– Cencora
IVD's
12:00 - 13:00
WEST
Evolving Role of Patients in the Pharmaceutical Landscape: a Two—way Street Enabled by Innovation
12:00 - 13:00
WEST
Evolving Role of Patients in the Pharmaceutical Landscape: a Two—way Street Enabled by Innovation
Speaker:
Amaia Clemente
– Sanofi
Speaker:
Anne Gervais, Pharmacist
– Sanofi
Pharmaceuticals
12:00 - 13:00
WEST
International Reliance
12:00 - 13:00
WEST
International Reliance
Speaker:
Peter Fry (he/him/his)
– QbD Group
Pharmaceuticals
12:00 - 13:00
WEST
RIM: Building Strong Business Regulatory Processes Around a Regulatory Information Management (RIM) System – a Scenario for Medical Devices
12:00 - 13:00
WEST
RIM: Building Strong Business Regulatory Processes Around a Regulatory Information Management (RIM) System – a Scenario for Medical Devices
Speaker:
Sanja Matern, PhD, RAC Devices (she/her/hers)
– Fresenius Medical Care Deutschland GmbH
Speaker:
Mandy Blocher
Medical Devices
12:00 - 13:00
WEST
Role of Patients
12:00 - 13:00
WEST
Role of Patients
Pharmaceuticals
13:00 - 14:30
WEST
Networking Lunch in the Exhibit Hall
13:00 - 14:30
WEST
Networking Lunch in the Exhibit Hall
13:10 - 13:35
WEST
Sponsored Presentations: Round 1
13:10 - 13:35
WEST
Sponsored Presentations: Round 1
Sponsored Presentation
13:15 - 13:45
WEST
Solutions Circle: Are You Really Ready for eCTD 4.0?
13:15 - 13:45
WEST
Solutions Circle: Are You Really Ready for eCTD 4.0?
Facilitator:
Diarmuid Waide
– Ennov
Solutions Circle
13:15 - 13:45
WEST
Solutions Circle: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)
13:15 - 13:45
WEST
Solutions Circle: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)
Presenter:
Marta Carnielli
– TUV Sud Product Service GmbH
Solutions Circle
13:15 - 13:45
WEST
Solutions Circle: The Summary of Safety and Clinical Performance: Enhancing Transparency and Empowering Patients
13:15 - 13:45
WEST
Solutions Circle: The Summary of Safety and Clinical Performance: Enhancing Transparency and Empowering Patients
Facilitator:
Susan Partridge, PhD (she/her/hers)
– BSI
Solutions Circle
13:15 - 13:45
WEST
Solutions Circle: Understanding the Medical Devices Approvals by the Reliance Route in Brazil: Criteria & Benefits
13:15 - 13:45
WEST
Solutions Circle: Understanding the Medical Devices Approvals by the Reliance Route in Brazil: Criteria & Benefits
Facilitator:
Patricia Luchiari Verrone, Pharmacist (she/her/hers)
– Vera Rosas Group
Solutions Circle
13:40 - 14:05
WEST
Sponsored Presentations: Round 2
13:40 - 14:05
WEST
Sponsored Presentations: Round 2
Sponsored Presentation
13:50 - 14:20
WEST
Solutions Circle: Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges Two Years On
13:50 - 14:20
WEST
Solutions Circle: Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges Two Years On
Presenter:
Alex Laan (he/him/his)
– BSI
Solutions Circle
13:50 - 14:20
WEST
Solutions Circle: Toxicological Thresholds in Chemical Characterization of Medical Devices: Practical Use of DBT, AET, and TSL
13:50 - 14:20
WEST
Solutions Circle: Toxicological Thresholds in Chemical Characterization of Medical Devices: Practical Use of DBT, AET, and TSL
Facilitator:
Adrien Marchand (he/him/his)
– Lucendra SA
Solutions Circle
13:50 - 14:20
WEST
Solutions Circle: Writing for RAPS
13:50 - 14:20
WEST
Solutions Circle: Writing for RAPS
Facilitator:
Denise Fulton
– RAPS
Facilitator:
Kim Young, MSc (she/her/hers)
– RAPS
Solutions Circle
14:05 - 14:30
WEST
Sponsored Presentations: Round 3
14:05 - 14:30
WEST
Sponsored Presentations: Round 3
Sponsored Presentation
14:30 - 15:30
WEST
Clinical Evidence as the Cornerstone of MDR Compliance: Lessons, Challenges, and the Road Ahead
14:30 - 15:30
WEST
Clinical Evidence as the Cornerstone of MDR Compliance: Lessons, Challenges, and the Road Ahead
Speaker:
Marianna Mastroroberto, NB 0476
– Kiwa Cermet Italia
Medical Devices
14:30 - 15:30
WEST
E-labelling: German DiGItal Project: A Blueprint for European-Wide Electronic Product Information Implementation in Healthcare Ecosystem
14:30 - 15:30
WEST
E-labelling: German DiGItal Project: A Blueprint for European-Wide Electronic Product Information Implementation in Healthcare Ecosystem
Speaker:
Sabine Faber, PhD
– Sanofi
Pharmaceuticals
14:30 - 15:30
WEST
EU AI Act: What Manufacturers Should Do Now
14:30 - 15:30
WEST
EU AI Act: What Manufacturers Should Do Now
Speaker:
Sebastian Fischer
– TÜV SÜD Product Service
Speaker:
Thorsten Stumpf
– Metecon GmbH
Speaker:
Dominik Kowalski
– Brainlab SE
Digital Health
14:30 - 15:30
WEST
Global Development Drug/Combination: Registration Across Major Markets EU, China, US
14:30 - 15:30
WEST
Global Development Drug/Combination: Registration Across Major Markets EU, China, US
Speaker:
Hamish King, RAC, LLB
– Cisema
Pharmaceuticals
14:30 - 15:30
WEST
Mastering Risk Management for In-vitro Diagnostics Transitioning From Pre to Post Market - How Much Is Enough?
14:30 - 15:30
WEST
Mastering Risk Management for In-vitro Diagnostics Transitioning From Pre to Post Market - How Much Is Enough?
Speaker:
Sue Spencer
– Compliance-Connextions Limited
Speaker:
Caroline Alexander
– Genedrive Diagnostics
Speaker:
Sean O'Callaghan
– BSI
Speaker:
Robyn Meurant
IVD's
14:30 - 15:30
WEST
The Mystic Neighbour: Notified Body Oversight with a Watch on SOTA, Risk, PMS, and Claims
14:30 - 15:30
WEST
The Mystic Neighbour: Notified Body Oversight with a Watch on SOTA, Risk, PMS, and Claims
Moderator:
Robert A. van Boxtel
– Medical Device Project B.V.
Speaker:
Markus Pöttker (he/him/his)
– Smith+Nephew
Speaker:
Sarah Panten
– avasis solutions GmbH / Medical Device Knowledge Unit e.V.
Speaker:
Florian Tolkmitt
– PRO-LIANCE GLOBAL SOLUTIONS GmbH
Medical Devices
15:30 - 16:45
WEST
Presenters at Posters (Exhibition Hall)
15:30 - 16:45
WEST
Presenters at Posters (Exhibition Hall)
15:30 - 16:45
WEST
Refreshment Break in the Exhibit Hall
15:30 - 16:45
WEST
Refreshment Break in the Exhibit Hall
15:45 - 16:10
WEST
Sponsored Presentations: Round 1
15:45 - 16:10
WEST
Sponsored Presentations: Round 1
16:15 - 16:40
WEST
Sponsored Presentations: Round 2
16:15 - 16:40
WEST
Sponsored Presentations: Round 2
Sponsored Presentation
16:45 - 18:00
WEST
Conversations That Matter: Interactions with Health Authorities
16:45 - 18:00
WEST
Conversations That Matter: Interactions with Health Authorities
Moderator:
Sabine Haubenreisser, MSc, PhD, FRAPS (she/her/hers)
– European Medicines Agency
Moderator:
Sabina L. Hoekstra, PharmD FRAPS
– TUV SUD
18:30 - 21:30
WEST
Networking Dinner (Ticket Required): Páteo Alfacinha
18:30 - 21:30
WEST
Networking Dinner (Ticket Required): Páteo Alfacinha
Thursday, May 7, 2026
07:30 - 18:00
WEST
Registration Hours
07:30 - 18:00
WEST
Registration Hours
08:30 - 09:30
WEST
FDA
08:30 - 09:30
WEST
FDA
Pharmaceuticals
08:30 - 09:30
WEST
Interoperability of Medical Devices in a Connected World - From Regulatory to Reality
08:30 - 09:30
WEST
Interoperability of Medical Devices in a Connected World - From Regulatory to Reality
Speaker:
Patrick Reichmann (he/him/his)
– Dedalus
Speaker:
Cecile E. van der Heijden (she/her/hers)
– Axon Lawyers
Speaker:
Lapo Bertini
Digital Health
08:30 - 09:30
WEST
PSUR: The Power of One: Aligning PSURs Across EU, GB and Canada
08:30 - 09:30
WEST
PSUR: The Power of One: Aligning PSURs Across EU, GB and Canada
Speaker:
Claudia Möller, M.Sc.
– Metecon GmbH
Speaker:
Markus Pöttker (he/him/his)
– Smith+Nephew
Speaker:
Jenifer Hannon, MTOPRA (she/her/hers)
– BSI
Medical Devices
08:30 - 09:30
WEST
The Unique Challenges of Managing Risks for IVDs Under ISO 14971:2019
08:30 - 09:30
WEST
The Unique Challenges of Managing Risks for IVDs Under ISO 14971:2019
Speaker:
Melissa Finocchio, ASQ CQE, ASQ CRE (she/her/hers)
– Proud Lion Services
IVD's
08:30 - 09:30
WEST
Variations 1 Year In
08:30 - 09:30
WEST
Variations 1 Year In
Pharmaceuticals
09:30 - 10:45
WEST
Refreshment Break in the Exhibit Hall
09:30 - 10:45
WEST
Refreshment Break in the Exhibit Hall
09:45 - 10:10
WEST
Sponsored Presentations - Round 1
09:45 - 10:10
WEST
Sponsored Presentations - Round 1
Sponsored Presentation
10:15 - 10:40
WEST
Sponsored Presentations - Round 2
10:15 - 10:40
WEST
Sponsored Presentations - Round 2
Sponsored Presentation
10:15 - 10:45
WEST
Solutions Circle: Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges Two Years On
10:15 - 10:45
WEST
Solutions Circle: Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges Two Years On
Presenter:
Alex Laan (he/him/his)
– BSI
Solutions Circle
10:15 - 10:45
WEST
Solutions Circle: RCC Informational Roundtable
10:15 - 10:45
WEST
Solutions Circle: RCC Informational Roundtable
Facilitator:
Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE
– RAPS
Solutions Circle
10:15 - 10:45
WEST
Solutions Circle: Toxicological Thresholds in Chemical Characterization of Medical Devices: Practical Use of DBT, AET, and TSL
10:15 - 10:45
WEST
Solutions Circle: Toxicological Thresholds in Chemical Characterization of Medical Devices: Practical Use of DBT, AET, and TSL
Facilitator:
Adrien Marchand (he/him/his)
– Lucendra SA
Solutions Circle
10:45 - 11:45
WEST
Change Notification Process of IVD Devices Under the IVDR: Are You Ready?!
10:45 - 11:45
WEST
Change Notification Process of IVD Devices Under the IVDR: Are You Ready?!
Speaker:
Alex Laan (he/him/his)
– BSI
IVD's
10:45 - 11:45
WEST
COMBINE: Navigating the Latest Trends in Combined Trials
10:45 - 11:45
WEST
COMBINE: Navigating the Latest Trends in Combined Trials
Speaker:
Maham Ansari, MS, RAC
– Precision for Medicine
Speaker:
Marina Belonogova, PhD (she/her/hers)
– Johnson & Johnson
Speaker:
Monique Al, PhD (she/her/hers)
– CCMO
Pharmaceuticals
10:45 - 11:45
WEST
Health Technology Assessment (HTA)
10:45 - 11:45
WEST
Health Technology Assessment (HTA)
Speaker:
Thomas Miramond
– NAMSA
Speaker:
Leslie Hammermueller
– AKRA Team GmbH
Medical Devices
10:45 - 11:45
WEST
MHRA AI Airlock, CERSI AI and RADIANT CERSI: Regulatory Innovation for AI Medical Devices
10:45 - 11:45
WEST
MHRA AI Airlock, CERSI AI and RADIANT CERSI: Regulatory Innovation for AI Medical Devices
Speaker:
Hannah Bowden (she/her/hers)
– Medicines and Healthcare Products Regulatory Agency
Speaker:
Alastair Denniston, PhD (he/him/his)
– University of Birmingham
Speaker:
Gabriella Spinelli
– Brunel University of London
Digital Health
10:45 - 11:45
WEST
Real-World Evidence
10:45 - 11:45
WEST
Real-World Evidence
Pharmaceuticals
10:45 - 11:45
WEST
SOTA: Breaking the Chicken-Egg Loop
10:45 - 11:45
WEST
SOTA: Breaking the Chicken-Egg Loop
Speaker:
Florian Tolkmitt
– PRO-LIANCE GLOBAL SOLUTIONS GmbH
Speaker:
Elke Bess (she/her/hers)
– TÜV Rheinland LGA Products GmbH, Notified Body 0197
Speaker:
Julia Rohrberg
– Heraeus Medical GmbH
Medical Devices
12:00 - 13:00
WEST
Conditional Approval Pathways and Strategies
12:00 - 13:00
WEST
Conditional Approval Pathways and Strategies
Pharmaceuticals
12:00 - 13:00
WEST
First Time Right – Best Practices for Generation of High-quality Data in IVDR Performance Studies
12:00 - 13:00
WEST
First Time Right – Best Practices for Generation of High-quality Data in IVDR Performance Studies
Speaker:
Kristiane Schmidt, PhD (she/her/hers)
– Qserve Consultancy
Speaker:
James Kerr
– BSI
IVD's
12:00 - 13:00
WEST
In Silico: Virtual Patients, Real Evidence: Part I -- The Current Use of In Silico Regulatory Evidence
12:00 - 13:00
WEST
In Silico: Virtual Patients, Real Evidence: Part I -- The Current Use of In Silico Regulatory Evidence
Speaker:
Grit Kasper (she/her/hers)
– Metecon GmbH
Speaker:
Surash Surash
– TÜV Süd
Speaker:
Philippe Favre, PhD (he/him/his)
– Zimmer Biomet
Speaker:
Okan Avci, Dr (he/him/his)
– Fraunhofer IPA
Medical Devices
12:00 - 13:00
WEST
Orphan Devices - Finding Rarity: A Case Study in Achieving Orphan Device Designation in the EU
12:00 - 13:00
WEST
Orphan Devices - Finding Rarity: A Case Study in Achieving Orphan Device Designation in the EU
Speaker:
Sandra Thiollière, MSc (she/her/hers)
– Carthera
Speaker:
Estelle Douceron
– RQM+
Medical Devices
12:00 - 13:00
WEST
Regulatory Affairs as a Cornerstone for NAMs Implementation Building Collaborative Pathways with EU Health Authorities
12:00 - 13:00
WEST
Regulatory Affairs as a Cornerstone for NAMs Implementation: Building Collaborative Pathways with EU Health Authorities
Speaker:
Béatrice Huret, PharmD
– Sanofi
Speaker:
Paul Desert
– Sanofi
Pharmaceuticals
12:00 - 13:00
WEST
Regulatory Sandboxes in Practice Turning AI Airlock Learnings Into Policy, Regulatory and Industry Strategy
12:00 - 13:00
WEST
Regulatory Sandboxes in Practice: Turning AI Airlock Learnings Into Policy, Regulatory and Industry Strategy
Speaker:
Natasha Motsi, BSc, MSc, PhD (she/her/hers)
– MHRA
Speaker:
Aruni Ghose, MD
– Barts Cancer Centre, St. Bartholomew’s Hospital, Barts Health NHS Trust, London
Speaker:
Emilie Santos, BSc. MSc. PhD (she/her/hers)
– Philips Healthcare
Digital Health
12:30 - 13:30
WEST
M4Q
12:30 - 13:30
WEST
M4Q
Pharmaceuticals
13:00 - 14:30
WEST
Networking Lunch in the Exhibit Hall
13:00 - 14:30
WEST
Networking Lunch in the Exhibit Hall
13:10 - 13:35
WEST
Sponsored Presentations - Round 1
13:10 - 13:35
WEST
Sponsored Presentations - Round 1
Sponsored Presentation
13:15 - 13:45
WEST
Solution Circle: Is Consent the Answer? Exploring Regulatory Options for Non-Compliant Devices in Australia
13:15 - 13:45
WEST
Solutions Circle: Is Consent the Answer? Exploring Regulatory Options for Non-Compliant Devices in Australia
Facilitator:
Kea Dent, MBA, GAICD, RAC (she/her/hers)
– KD&A
Solutions Circle
13:15 - 13:45
WEST
Solutions Circle: Building Foundational Skills for Regulators in the Age of Artificial Intelligence
13:15 - 13:45
WEST
Solutions Circle: Building Foundational Skills for Regulators in the Age of Artificial Intelligence
Facilitator:
Katy Slater
– Komorebi Ltd
Solutions Circle
13:15 - 13:45
WEST
Solutions Circle: Early Market Access to Innovative Diagnostics
13:15 - 13:45
WEST
Solutions Circle: Early Market Access to Innovative Diagnostics
Facilitator:
Nadine Neale
– Medicines and Healthcare Products Regulatory Agency
Solutions Circle
13:15 - 13:45
WEST
Solutions Circle: Was SoHO Born From HCT/Ps?
13:15 - 13:45
WEST
Solutions Circle: Was SoHO Born From HCT/Ps?
Facilitator:
Mark Levi, PhD
– RTI
Solutions Circle
13:40 - 14:05
WEST
Sponsored Presentations - Round 2
13:40 - 14:05
WEST
Sponsored Presentations - Round 2
Sponsored Presentation
13:50 - 14:20
WEST
Solution Circle: Up, Close and Practical with the European Health Data Space
13:50 - 14:20
WEST
Solutions Circle: Up, Close and Practical with the European Health Data Space
Facilitator:
Cecile E. van der Heijden (she/her/hers)
– Axon Lawyers
Solutions Circle
13:50 - 14:20
WEST
Solutions Circle: Regulators Are Using AI — Is Your Submission Ready to Be Reviewed by One?
13:50 - 14:20
WEST
Solutions Circle: Regulators Are Using AI — Is Your Submission Ready to Be Reviewed by One?
Facilitator:
Josh Kim
– Artos AI
Solutions Circle
13:50 - 14:20
WEST
Solutions Circle: The Pitfalls of Only Applying ISO 14971:2019 When Applying for MDR
13:50 - 14:20
WEST
Solutions Circle: The Pitfalls of Only Applying ISO 14971:2019 When Applying for MDR
Facilitator:
Rachel K. Gibbs
– NAMSA
Solutions Circle
13:50 - 14:20
WEST
Solutions Circle: Updates on the Battery Regulation (EU) 2023/1542 and Their Impact on Medical Devices
13:50 - 14:20
WEST
Solutions Circle: Updates on the Battery Regulation (EU) 2023/1542 and Their Impact on Medical Devices
Facilitator:
Christoph Kiesselbach (he/him/his)
– Schrack & Partner
Solutions Circle
14:05 - 14:30
WEST
Sponsored Presentations - Round 3
14:05 - 14:30
WEST
Sponsored Presentations - Round 3
Sponsored Presentation
14:30 - 15:30
WEST
ATMPs
14:30 - 15:30
WEST
ATMPs
Speaker:
Darius-Jean Namdjou, PhD
– Phortas GmbH
Speaker:
Mohamad Toutounji, M.D. (he/him/his)
– Molgenium
Pharmaceuticals
14:30 - 15:30
WEST
Clinical Trials: Anticipating the New Clinical Trial Regulations in the UK. What Is Changing?
14:30 - 15:30
WEST
Clinical Trials: Anticipating the New Clinical Trial Regulations in the UK. What Is Changing?
Speaker:
Dmitry Obolskiy, PhD
– RAPS Member
Pharmaceuticals
14:30 - 15:30
WEST
Environmental Convergence: Horizontal EU Requirements Reshaping Medical Device and IVD Regulation
14:30 - 15:30
WEST
Environmental Convergence: Horizontal EU Requirements Reshaping Medical Device and IVD Regulation
Speaker:
Erik R. Vollebregt
– Axon Lawyers
Speaker:
Darren J. Thain, RCC
– Smith+Nephew
Medical Devices
14:30 - 15:30
WEST
Multi-Omics & AI
14:30 - 15:30
WEST
Advancing Point-of-Care Multi-Omics & AI in Clinical Practice: Regulatory Readiness Across Medical Devices and Pharma
Speaker:
Cindy Welzel, PhD
– Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology
Digital Health
14:30 - 15:30
WEST
Novel Approaches for PMPF Surveys Under IVDR – Industry and Notified Body Perspectives
14:30 - 15:30
WEST
Novel Approaches for PMPF Surveys Under IVDR – Industry and Notified Body Perspectives
Speaker:
Margot J. Borgel, PhD
– RQM+
Speaker:
Bethany Chung, PhD, RAC
– RQM+
Speaker:
James Kerr
– BSI
IVD's
14:30 - 15:30
WEST
UK MDR
14:30 - 15:30
WEST
UK MDR
Speaker:
Vishal Thakker, MEng (he/him/his)
– BSI
Speaker:
Dennis Sarwin, MSc
– Qserve Group
Speaker:
Ashleigh Batchen (she/her/hers)
– TÜV SÜD
Medical Devices
15:30 - 16:45
WEST
Refreshment Break in the Exhibit Hall
15:30 - 16:45
WEST
Refreshment Break in the Exhibit Hall
15:45 - 16:10
WEST
Sponsored Presentations - Round 1
15:45 - 16:10
WEST
Sponsored Presentations - Round 1
Sponsored Presentation
16:15 - 16:40
WEST
Sponsored Presentations - Round 2
16:15 - 16:40
WEST
Sponsored Presentations - Round 2
Sponsored Presentation
16:45 - 17:45
WEST
Any Question Goes?
16:45 - 17:45
WEST
Any Question Goes?
Pharmaceuticals
16:45 - 17:45
WEST
Digital Mental Health Apps: The Role of Regulatory Collaboration for Harmonisation and Enablement of Safe and Effective Innovation
16:45 - 17:45
WEST
Digital Mental Health Apps: The Role of Regulatory Collaboration for Harmonisation and Enablement of Safe and Effective Innovation
Speaker:
Holly Coole, Bsc
– Medicines and Healthcare Products Regulatory Agency (MHRA)
Speaker:
Rolf Oberlin Hansen, Biomedical Engineer
– Danish Medicines Agency (DKMA)
Speaker:
Sophie Hughes
Digital Health
16:45 - 17:45
WEST
Implants
16:45 - 17:45
WEST
Implants
Speaker:
Heitor M A Korndorfer
– MSC MED ENGENHARIA E TECNOLOGIA MEDICA
Speaker:
Sophie Tabutin
– RAPS Entreprise Member
Speaker:
Jay K. Katta
– BSI
Medical Devices
16:45 - 17:45
WEST
Navigating the Challenges of Medical AI Usability
16:45 - 17:45
WEST
Navigating the Challenges of Medical AI Usability
Speaker:
Mariana de Oliveira
– University of Lisbon, Faculty of Sciences
Speaker:
Jonathan Kendler
– Curiolis, Inc.
Speaker:
Constança Roquette
– Nova School of Business and Economics Health Economics & Management Knowledge Center
Speaker:
Mafalda Carvalho
– North Lisbon University Hospital Centre (ULS Santa Maria)
Medical Devices
16:45 - 17:45
WEST
Post-Market Surveillance
16:45 - 17:45
WEST
Post-Market Surveillance
Speaker:
Goran Abdurrahman (he/him/his)
– TÜV Rheinland
Speaker:
Lisa Schälter
– Be-on-Quality GmbH
IVD's
16:45 - 17:45
WEST
Supply Chain/Manufacturing
16:45 - 17:45
WEST
Supply Chain/Manufacturing
Speaker:
Allison E. Radwick, RPh, PhD
– USP
Pharmaceuticals
Friday, May 8, 2026
07:30 - 13:00
WEST
Registration Hours
07:30 - 13:00
WEST
Registration Hours
08:30 - 10:00
WEST
Plenary Session
08:30 - 10:00
WEST
Plenary Session
10:00 - 11:15
WEST
Refreshment Break in the Exhibit Hall
10:00 - 11:15
WEST
Refreshment Break in the Exhibit Hall
10:05 - 10:30
WEST
Sponsored Presentations: Round 1
10:05 - 10:30
WEST
Sponsored Presentations: Round 1
Sponsored Presentation
10:10 - 10:40
WEST
Solutions Circle: The Pitfalls of Only Applying ISO 14971:2019 When Applying for MDR
10:10 - 10:40
WEST
Solutions Circle: The Pitfalls of Only Applying ISO 14971:2019 When Applying for MDR
Facilitator:
Rachel K. Gibbs
– NAMSA
Solutions Circle
10:40 - 11:05
WEST
Sponsored Presentations: Round 2
10:40 - 11:05
WEST
Sponsored Presentations: Round 2
Sponsored Presentation
10:45 - 11:15
WEST
Solutions Circle: Compliance Amidst Uncertainties for Medical Devices
10:45 - 11:15
WEST
Solutions Circle: Compliance Amidst Uncertainties for Medical Devices
Facilitator:
Gert BQ Bos, MSc, PhD, FRAPS
– Qserve Group
Facilitator:
Florian Tolkmitt
– PRO-LIANCE GLOBAL SOLUTIONS GmbH
Solutions Circle
11:15 - 12:15
WEST
Biocompatibility - ISO 10993
11:15 - 12:15
WEST
Biocompatibility - ISO 10993
Speaker:
Petr Bratka, PhD (he/him/his)
– Centre for Medical Devices Certification, Czech Metrology Institute
Speaker:
Michelle Kelly, N/A, ERT
– British Toxicology Society
Speaker:
Patrícia da Silva Pérez, PhD
– Qserve Group
Medical Devices
11:15 - 12:15
WEST
Combination Products
11:15 - 12:15
WEST
Combination Products
Speaker:
Tiina A. Riihimäki (she/her/hers)
– Cencora
Speaker:
Theresa Jeary
– BSI
Speaker:
Ana Pilar Olmos
– Beyond Conception
Pharmaceuticals
11:15 - 12:15
WEST
HTA Regulations(Joint Assesment)
11:15 - 12:15
WEST
HTA Regulations(Joint Assesment)
Pharmaceuticals
11:15 - 12:15
WEST
International Reliance: Medical Devices in the Tropics: Tips, Tricks and Odds for Your ANVISA Submission
11:15 - 12:15
WEST
International Reliance: Medical Devices in the Tropics: Tips, Tricks and Odds for Your ANVISA Submission
Speaker:
Bruno J S Oliveira, Sr., MSc (he/him/his)
– MSC MED Engenharia e Tecnologia Médica Ltda.
Medical Devices
11:15 - 12:15
WEST
Performance Evaluation
11:15 - 12:15
WEST
Performance Evaluation
Speaker:
Carlos Galamba, MSc
– MDx CRO
Speaker:
Javier Varela (he/him/his)
– Pharmalex
IVD's
11:15 - 12:15
WEST
PMS, PMCF & Monitoring of AI Systems
11:15 - 12:15
WEST
PMS, PMCF & Monitoring of AI Systems
Speaker:
Catarina Carrão
– BioSciPons
Speaker:
Zuzanna Kwade, MSc, PhD (she/her/hers)
– Dedalus Healthcare, Brussels Hoofdstedelijk Gewest, Belgium
Speaker:
Vanda Almeida, PhD
– Philips
Digital Health
12:30 - 13:30
WEST
AI-Powered Conformity Assessment Transforming Notified Body Operations
12:30 - 13:30
WEST
AI-Powered Conformity Assessment: Transforming Notified Body Operations
Speaker:
Erik R. Vollebregt
– Axon Lawyers
Speaker:
Tom Patten
– GMED
Medical Devices
12:30 - 13:30
WEST
Aligning Regulatory and HTA Strategies of Digital Health Technologies to Reduce Duplication of Effort and Resources
12:30 - 13:30
WEST
Aligning Regulatory and HTA Strategies of Digital Health Technologies to Reduce Duplication of Effort and Resources
Speaker:
Rebecca Mathias (she/her/hers)
– Else Kröner Fresenius Center for Digital Health, TU Dresden
Speaker:
Stephen Gilbert, PhD (he/him/his)
– Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Speaker:
Tom Melvin, M.D.
– Institute for Clinical Trials, University of Galway
Speaker:
David Epstein, Prof.
– Department of Applied Economics, University of Granada, Spain
Digital Health
12:30 - 13:30
WEST
Environment Regulatory
12:30 - 13:30
WEST
Environment Regulatory
Speaker:
Thomas Wejs Møller, Master's degree in Political Science
– EFPIA ERAO and Device Group
Speaker:
Jacob Moberg Sandager, Master’s degree in Materials and Manufacturing (he/him/his)
– Novo Nordisk
Pharmaceuticals
12:30 - 13:30
WEST
Falsified Medical Devices & Certificates
12:30 - 13:30
WEST
Falsified Medical Devices & Certificates
Speaker:
Jean McKenzie, MSc
– DEKRA Certification B.V.
Medical Devices
12:30 - 13:30
WEST
In-house Tests/LTDs
12:30 - 13:30
WEST
In-house Tests/LTDs
Speaker:
Andreas Oberleitner, MSc (he/him/his)
– Platomics
Speaker:
Natalie Batty, MPH
– Aignostics
Speaker:
Marina Belonogova, PhD (she/her/hers)
– Johnson & Johnson
IVD's
13:30 - 14:30
WEST
Euro Convergence - Farewell Lunch
13:30 - 14:30
WEST
Euro Convergence - Farewell Lunch