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Wednesday, May 14th
09:45 - 10:10 CEST
Celegence: AI in Technical and Clinical Writing: Cutting Through the Hype with Real-world Examples
Location: Exhibit Hall - 2.Discover!
Speaker: Joseph-Richardson Larbi, MSc – Celegence
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Wednesday, May 14th
09:45 - 10:10 CEST
Johner Institut Gmbh: Regulatory Intelligence E2E – Is It Worth the Invest?
Location: Exhibit Hall - 1. Spark!
Speaker: Andrea Seeck – Johner Institut GmbH
Speaker: Leon Holub – Johner Institut GmbH
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Wednesday, May 14th
10:15 - 10:40 CEST
NAMSA: Understanding FDA Preclinical Animal Study Requirements for Medical Devices
Location: Exhibit Hall - 1. Spark!
Speaker: Gaëlle Clermont, Pharm.D., PhD (she/her/hers) – NAMSA
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Wednesday, May 14th
10:15 - 10:40 CEST
Purdie Pascoe: Mastering PMCF Data Collection: How to Overcome Challenges with PMCF Surveys
Location: Exhibit Hall - 2.Discover!
Speaker: Marcus Torr, MSci – Purdie Pascoe
Speaker: Gavin Quigley, MBChB FRCS MBA – British Standards Institution
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Wednesday, May 14th
13:10 - 13:35 CEST
Flinn AI: The AI Validation Confidence Index - Discover How Much You Can Trust Your AI
Location: Exhibit Hall - 2.Discover!
Speaker: Tibor Zechmeister, BSc MSc EMBA – Flinn.ai
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Wednesday, May 14th
13:10 - 13:35 CEST
Medenvoy Global: Ensuring Compliance Across the Distribution Chain: A Deep Dive into Economic Operators’ Roles
Location: Exhibit Hall - 1. Spark!
Speaker: Daniëlle Sleegers – MedEnvoy Global
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Wednesday, May 14th
13:40 - 14:05 CEST
Eclevar Medtech: Smart PMCF for Medical Devices: AI-powered EDC for Cost Savings, MDR Compliance
Location: Exhibit Hall - 2.Discover!
Speaker: Chems Hachani – Eclevar Medtech
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Wednesday, May 14th
13:40 - 14:05 CEST
Qbd Group: Can IVDR Be Your Global Regulatory Compass for Market Entry?
Location: Exhibit Hall - 1. Spark!
Speaker: Pieter C. Bogaert, PhD (he/him/his) – Qarad (part of QbD Group)
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Wednesday, May 14th
14:05 - 14:30 CEST
RIMSYS: Getting Your Ducks in a Row for a Successful EUDAMED (and Global) UDI Program
Location: Exhibit Hall - 1. Spark!
Speaker: Adam Price, MBA – Rimsys
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Wednesday, May 14th
14:05 - 14:30 CEST
RQM+: Quo Vadis, FDA - And Where Should We Go To...?
Location: Exhibit Hall - 2.Discover!
Speaker: Alexia Haralambous, MS, RAC – RQM+
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Wednesday, May 14th
15:45 - 16:10 CEST
Essenvia RIM Platform: Navigating the Perfect Storm: FDA Capacity Cuts, Tariffs & the New RA Playbook
Location: Exhibit Hall - 1. Spark!
Speaker: Soumya Mahapatra (he/him/his) – Essenvia
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Wednesday, May 14th
15:45 - 16:10 CEST
Pure Global: AI in Action - Transforming Regulatory Workflows for Smarter Technical Documentation and Global Submissions
Location: Exhibit Hall - 2.Discover!
Speaker: Oliver Eikenberg – Pure Global
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Wednesday, May 14th
16:15 - 16:40 CEST
REG DESK: The Future of Regulatory Affairs: how Technology Is Shaping Regulatory Compliance
Location: Exhibit Hall - 1. Spark!
Speaker: Priya Paul, BS, MS, MS (she/her/hers) – RegDesk, Inc.
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Wednesday, May 14th
16:15 - 16:40 CEST
Veeva Systems Inc: Exploring the Ai-powered Future of Promotional Material Review
Location: Exhibit Hall - 2.Discover!
Moderator: Pearl Vyas – Veeva Systems
Speaker: Michael Konings – Philips
Speaker: Erik R. Vollebregt – Axon Lawyers
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Thursday, May 15th
09:45 - 10:10 CEST
MDSS Gmbh: The Importer Under MDR. Why the MDR Requirements Are a Blessing!
Location: Exhibit Hall - 1. Spark!
Speaker: Ludger Moeller (he/him/his) – MDSS GmbH
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Thursday, May 15th
09:45 - 10:10 CEST
Medsec LLC: Cybersecurity Risk Management: Your Next Submission’s Secret Weapon
Location: Exhibit Hall - 2.Discover!
Speaker: Michelle Jump, RAC, MS (she/her/hers) – MedSec LLC
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Thursday, May 15th
10:15 - 10:40 CEST
Osapiens / Byrd.health: Are You up to the 2025 EUDAMED Challenge?
Location: Exhibit Hall - 2.Discover!
Speaker: Henning Jaeger, M.A. – Osapiens for Medical Devices (BYRD Health)
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Thursday, May 15th
10:15 - 10:40 CEST
Weave Bio: Evaluating Time Savings in Regulatory Writing: A Scientific Comparison of Human and AI Approaches
Location: Exhibit Hall - 1. Spark!
Speaker: Lindsay Mateo, MBA (she/her/hers) – Weave Bio
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Thursday, May 15th
13:10 - 13:35 CEST
Medboard: Streamlining Regulatory Intelligence and Literature Reviews with Automation and AI: Case Studies and Proven Value
Location: Exhibit Hall - 1. Spark!
Speaker: Ivan Perez Chamorro – MedBoard
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Thursday, May 15th
13:10 - 13:35 CEST
Pearl Pathways: The Global Regulatory Landscape for Companion Diagnostics
Location: Exhibit Hall - 2.Discover!
Speaker: Kimberley Buytaert-Hoefen, Ph.D – Pearl Pathways, part of Versiti Clinical Trial Services
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Thursday, May 15th
13:40 - 14:05 CEST
Lexisnexis Reed Tech: EUDAMED UDI: What You Need to Know to Be Compliant
Location: Exhibit Hall - 2.Discover!
Speaker: Gary Saner – LexisNexis Reed Tech
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Thursday, May 15th
13:40 - 14:05 CEST
Qserve Group: Navigating the Political Shifts in Global Regulatory Affairs
Location: Exhibit Hall - 1. Spark!
Speaker: Gert W. Bos, PhD FRAPS – QServe Group
Speaker: Robert Paassen, MSc (he/him/his) – Qserve Group
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Thursday, May 15th
14:05 - 14:30 CEST
Greenlight Guru: 2025 State of the Medical Device Industry Report
Location: Exhibit Hall - 1. Spark!
Presenter: Taylor Holcomb, MS – Greenlight Guru
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Thursday, May 15th
14:05 - 14:30 CEST
Ketryx Corporation: Ai-driven Document Orchestration and Generation: Managing Systems of Systems, Modular Software Services, and Compliance at Scale
Location: Exhibit Hall - 2.Discover!
Speaker: Jenn Dixon, P.Eng (she/her/hers) – Ketryx
Speaker: Natalie Batty, MPH – Aignostics
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Thursday, May 15th
15:45 - 16:10 CEST
Kiwa Medical: MDR and Clinical Investigation: What’s New?
Location: Exhibit Hall - 1. Spark!
Speaker: Chirine El Baba, PhD – Kiwa
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Thursday, May 15th
15:45 - 16:10 CEST
TÜV SÜD: MDR Structured Dialogue: Clinical Edition
Location: Exhibit Hall - 2.Discover!
Speaker: Martin Witte (he/him/his) – TÜV SÜD Medical & Health Services
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Thursday, May 15th
16:15 - 16:40 CEST
1MED SA: Do I Really Need a Trial? - Smart Solutions to Collect Clinical Data
Location: Exhibit Hall - 2.Discover!
Speaker: Alessandro Malaspina, MS (he/him/his) – 1MED
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Thursday, May 15th
16:15 - 16:40 CEST
MAIN5: EMA PMS Data Alignment: Automating Medicinal Product Data Compliance with Improved Operational Efficiency
Location: Exhibit Hall - 1. Spark!
Speaker: Michiel Stam – MAIN5
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