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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
SSCP – The Challenge of Determining Frequencies of Side Effects and Residual Risks in Medical Devices
08:30 - 09:30
WEST
SSCP – The Challenge of Determining Frequencies of Side Effects and Residual Risks in Medical Devices
Speaker:
Sonja Hirte
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, PhD (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
