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Learning Level: Foundational
Learning Level: Intermediate
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Tue, May 5
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Wednesday, May 6, 2026
07:30 - 18:00
WEST
Registration Hours
07:30 - 18:00
WEST
Registration Hours
07:30 - 18:30
WEST
Cloakroom
07:30 - 18:30
WEST
Cloakroom
08:30 - 09:30
WEST
AI Tools
08:30 - 09:30
WEST
AI Tools
Location: Auditorium 4
Speaker:
Frank Pétavy, MSc (he/him/his)
– European Medicines Agency
Pharmaceuticals
08:30 - 09:30
WEST
Cybersecurity
08:30 - 09:30
WEST
Cybersecurity
Location: Room 3A-C
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
Location: Auditorium 1
Moderator:
Gert BQ Bos, PhD FRAPS (he/him/his)
– QServe Group
Moderator:
Sabina L. Hoekstra, PharmD, FRAPS
– TÜV SÜD Medical Health Services
Panelist:
Elizabeth Gfoeller, MA
– MED-EL
Medical Devices
08:30 - 09:30
WEST
New Pharma Legislation: Part 1
08:30 - 09:30
WEST
New Pharma Legislation: Part 1
Location: Room 5A-C
Moderator:
Alberto Ganan, PhD
– European Medicines Agency
Panelist:
Yves Jacob (he/him/his)
– Sanofi
Panelist:
Steffen Thirstrup, MD, PhD (he/him/his)
– European Medicines Agency (EMA)
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
Location: Auditorium 2
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
Location: Auditorium 3
Speaker:
Sara Fabi, MSc
– BSI group
Speaker:
Ellen van Loon, PhD (she/her/hers)
– DEKRA Certification B.V.
Speaker:
Guillaume Berger
– GMED
IVD's
09:30 - 10:45
WEST
Chapter and Local Networking Group (LNG) Meet & Greet
09:30 - 10:45
WEST
Chapter and Local Networking Group (LNG) Meet & Greet
Location: RAPS Central - Exhibition Hall
09:30 - 10:45
WEST
Presenters at Posters (Exhibition Hall)
09:30 - 10:45
WEST
Presenters at Posters (Exhibition Hall)
Location: Exhibition - Hall 2
09:30 - 10:45
WEST
Refreshment Break in the Exhibit Hall
09:30 - 10:45
WEST
Refreshment Break in the Exhibit Hall
Location: Exhibition - Hall 2
09:30 - 18:00
WEST
Exhibition Hall - Open hours
09:30 - 18:00
WEST
Exhibition Hall - Open hours
Location: Exhibition - Hall 2
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
Location: Exhibition - Hall 2
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
Location: Exhibition - Hall 2
Facilitator:
Nadine Neale, PGDip (she/her/hers)
– 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
Location: Exhibition - Hall 2
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?
Location: Exhibition - Hall 2
Facilitator:
Mark Levi, PhD
– RTI
Solutions Circle
09:40 - 10:20
WEST
Solutions Cirle: Regdesk
09:40 - 10:20
WEST
Solutions Cirle: Regdesk
Location: Exhibition - Hall 2
Solutions Circle
Supported by
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
Location: Exhibition - Hall 2
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?
Location: Exhibition - Hall 2
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
Location: Exhibition - Hall 2
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
Location: Exhibition - Hall 2
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
Location: Auditorium 2
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
Location: Auditorium 4
Speaker:
Ellen van Loon, PhD (she/her/hers)
– DEKRA Certification B.V.
Speaker:
Ines Labugger, PhD (she/her/hers)
– TÜV SÜD
IVD's
10:45 - 11:45
WEST
Deregulation/Centralization
10:45 - 11:45
WEST
Deregulation/Centralization
Location: Auditorium 1
Medical Devices
10:45 - 11:45
WEST
New Pharma Legislation: Part 2
10:45 - 11:45
WEST
New Pharma Legislation: Part 2
Location: Room 5A-C
Moderator:
Rebecca Lumsden, PhD (she/her/hers)
– Sanofi
Speaker:
Yves Jacob (he/him/his)
– Sanofi
Panelist:
Alberto Ganan, PhD
– European Medicines Agency
Pharmaceuticals
10:45 - 11:45
WEST
Singing in Harmony: Leveraging MDSAP to Synergize your QMS
10:45 - 11:45
WEST
Singing in Harmony: Leveraging MDSAP to Synergize your QMS
Location: Room 3A-C
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
Strategy & Funding: Rise of Regulatory as a Business Driver
10:45 - 11:45
WEST
Strategy & Funding: Rise of Regulatory as a Business Driver
Location: Auditorium 3
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?
Location: Auditorium 1
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 Evidence beyond Clinical Data, a practical approach considering current legislation and future outlook
12:00 - 13:00
WEST
Clinical Evidence beyond Clinical Data, a practical approach considering current legislation and future outlook
Location: Room 3A-C
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
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
Location: Room 5A-C
Speaker:
Amaia Clemente, Pharm
– Sanofi
Speaker:
Anne Gervais, Pharmacist (she/her/hers)
– Sanofi
Panelist:
Kaisa Immonen, MA
– European Medicines Agency
Speaker:
Rosa Gonzalez-Quedo
Pharmaceuticals
12:00 - 13:00
WEST
Navigating Global CTR–IVDR Trials: Real-World Challenges and Practical Lessons
12:00 - 13:00
WEST
Navigating Global CTR–IVDR Trials: Real-World Challenges and Practical Lessons
Location: Auditorium 3
Speaker:
Carlos Galamba, MSc
– MDx CRO
Speaker:
Kirsten Van Garsse, RCC (she/her/hers)
– QbD Group NV
Speaker:
Audrey Toulemonde, MSc (she/her/hers)
– Cencora
Panelist:
Stiina Aarum
– European Medicines Agency (EMA)
IVD's
12:00 - 13:00
WEST
Opportunities and Challenges with International Collaborative Initiatives
12:00 - 13:00
WEST
Opportunities and Challenges with International Collaborative Initiatives
Location: Auditorium 4
Session Leader/Speaker:
Victoria Palmi Reig
– European Medicines Agency (EMA)
Speaker:
Peter Fry (he/him/his)
– QbD Group
Speaker:
Ines Lenic, MSc
– AstraZeneca
Speaker:
Tasneem Fatima Keshavji
– MHRA
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
Location: Auditorium 2
Speaker:
Sanja Matern, PhD, RAC Devices (she/her/hers)
– Fresenius Medical Care Deutschland GmbH
Speaker:
Mandy Blocher (she/her/hers)
– Aesculap AG
Speaker:
Kirsten Eickhoff (she/her/hers)
– HOYA SURGICAL OPTICS
Medical Devices
13:00 - 14:30
WEST
Networking Lunch in the Exhibit Hall
13:00 - 14:30
WEST
Networking Lunch in the Exhibit Hall
Location: Exhibition - Hall 2
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?
Location: Exhibition - Hall 2
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)
Location: Exhibition - Hall 2
Presenter:
Marta Carnielli
– TUV SUD
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
Location: Exhibition - Hall 2
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
Location: Exhibition - Hall 2
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
Location: Exhibition - Hall 2
Presenter:
Alex Laan (he/him/his)
– BSI
Solutions Circle
13:50 - 14:20
WEST
Solutions Circle: Reliance That Delivers: From WHO Good Reliance Practices to Project Orbis
13:50 - 14:20
WEST
Solutions Circle: Reliance That Delivers: From WHO Good Reliance Practices to Project Orbis
Location: Exhibition - Hall 2
Facilitator:
Hagit Marchaim, PhD, MBA (she/her/hers)
– HMC-regulation
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
Location: Exhibition - Hall 2
Facilitator:
Adrien Marchand (he/him/his)
– Lucendra SA
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
Location: Auditorium 2
Speaker:
Marianna Mastroroberto, NB 0476
– Kiwa Cermet Italia
Medical Devices
14:30 - 15:30
WEST
Electronic Product Information (ePI) in Action: From Pilots to successful Implementation in Europe
14:30 - 15:30
WEST
Electronic Product Information (ePI) in Action: From Pilots to successful Implementation in Europe
Location: Room 5A-C
Moderator:
Mercè Caturla Goñi, PhD (she/her/hers)
Speaker:
Sabine Faber, PhD
– Sanofi
Speaker:
Norbert Gerbsch, MSc, PhD (he/him/his)
– IGES Institut GmbH
Speaker:
Elizabeth Scanlan, MSc, PhD
– European Medicines Agency
Pharmaceuticals
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
Location: Auditorium 3
Speaker:
Hamish King, LLB, RACS
– Cisema
Speaker:
Alberto Ganan, PhD
– European Medicines Agency
Speaker:
Matthew Krueger, M.S., RAC (U.S.)
– Biologics Consulting Group, Inc.
Pharmaceuticals
14:30 - 15:30
WEST
Implementing the EU AI Act in Practice – A Catchbox Session
14:30 - 15:30
WEST
Implementing the EU AI Act in Practice – A Catchbox Session
Location: Room 3A-C
Moderator:
Koen Cobbaert, MsC (he/him/his)
– Philips
Speaker:
Sebastian Fischer
– TÜV SÜD Product Service
Speaker:
Thorsten Stumpf, MA (he/him/his)
– Metecon GmbH
Speaker:
Dominik Kowalski
– Brainlab SE
Digital Health
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?
Location: Auditorium 4
Speaker:
Sue Spencer
– Compliance-Connextions Limited
Speaker:
Caroline Alexander
– Genedrive Diagnostics
Speaker:
Sean O'Callaghan, BSc MSc
– BSI
Speaker:
Robyn Meurant, BAppSc
– ACT-IVD
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
Location: Auditorium 1
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)
Location: Exhibition - Hall 2
15:30 - 16:45
WEST
Refreshment Break in the Exhibit Hall
15:30 - 16:45
WEST
Refreshment Break in the Exhibit Hall
Location: Exhibition - Hall 2
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 - 18:00
WEST
Conversations That Matter: Interactions with Health Authorities
16:45 - 18:00
WEST
Conversations That Matter: Interactions with Health Authorities
Location: Auditorium 1
Moderator:
Sabine Haubenreisser, MSc, PhD, FRAPS (she/her/hers)
– European Medicines Agency
Moderator:
Sabina L. Hoekstra, PharmD, FRAPS
– TÜV SÜD Medical Health Services
Panelist:
Alberto Ganan, PhD
– European Medicines Agency
Panelist:
Silvy Da Rocha Dias
– European Medicines Agency
18:30 - 21:30
WEST
Networking Dinner (Ticket Required): Páteo Alfacinha
18:30 - 21:30
WEST
Networking Dinner (Ticket Required): Páteo Alfacinha
Location: Páteo Alfacinha
Sponsored By