Sponsored Presentations - Exhibition Hall

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Wednesday, May 6th
09:45 - 10:10 WEST
Sponsored Presentations - Round 1: Breakthrough Medical Devices: Pathway to Market
Location: Exhibition Hall - Discover!
Speaker: Thomas Doerge (he/him/his) – BSI Group
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Wednesday, May 6th
09:45 - 10:10 WEST
Sponsored Presentations - Round 1: From Compliance to Control: Building a Quality Operating System for Regulated Growth
Location: Exhibition Hall - Spark!
Speaker: Chris Hayden, MSc – Scilife
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Wednesday, May 6th
10:15 - 10:40 WEST
Sponsored Presentations - Round 2: Real Data, Real Results: Unlocking the Power of Post-Market Surveys
Location: Exhibition Hall - Spark!
Speaker: Marcus Torr, MSci – Purdie Pascoe
Speaker: Alice Robertson – Purdie Pascoe
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Wednesday, May 6th
10:15 - 10:40 WEST
Sponsored Presentations - Round 2: The Regulatory Approval Illusion: Why Errors Still Escape in 2026
Location: Exhibition Hall - Discover!
Speaker: Arpad Lehoczki (he/him/his) – GlobalVision
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Wednesday, May 6th
13:30 - 13:55 WEST
Sponsored Presentations - Round 1: From MDR/IVDR 1.0 to 2.0: Real-World Data Driving Smarter Evidence Strategies
Location: Exhibition Hall - Spark!
Speaker: Wouter Mattheussens – QServe Group
Speaker: Gert W. Bos, PhD FRAPS (he/him/his) – QServe Group
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Wednesday, May 6th
13:30 - 13:55 WEST
Sponsored Presentations - Round 1: Ensuring Compliance Across the Distribution Chain: A Deep Dive into Economic Operators’ Roles
Location: Exhibition Hall - Discover!
Speaker: Edgar Kasteel – MedEnvoy Global BV
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Wednesday, May 6th
14:00 - 14:25 WEST
Sponsored Presentations - Round 2: How to Rapidly Gain Real-World Value from Regulatory Technology in the Era of AI
Location: Exhibition Hall - Discover!
Speaker: Soumya Mahapatra (he/him/his) – Essenvia, Inc.
Speaker: Bijal Patel-Jain – LivaNova
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Wednesday, May 6th
14:00 - 14:25 WEST
Sponsored Presentations - Round 2: Conquering Regulatory Barriers: Strategies for Effective Representation and Ongoing Compliance Monitoring
Location: Exhibition Hall - Spark!
Speaker: Leon Holub – Johner Institut GmbH
Speaker: Lesley Ploen, MSc – Johner Institut GmbH
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Wednesday, May 6th
15:45 - 16:10 WEST
Sponsored Presentations - Round 1: From Regulatory Overload to AI-Driven Regulatory Leadership
Location: Exhibition Hall - Discover!
Speaker: Ivan Perez Chamorro – MedBoard
Speaker: Sarah Haake-Schäfer (she/her/hers) – Carl Zeiss Vision International GmbH
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Wednesday, May 6th
15:45 - 16:10 WEST
Sponsored Presentations - Round 1: What High-Growth Companies Do Differently in Regulatory: From Compliance Function to Strategic Growth Engine
Location: Exhibition Hall - Spark!
Speaker: Priya Bhutani, BS, MS, MS (she/her/hers) – RegDesk, Inc.
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Wednesday, May 6th
16:15 - 16:40 WEST
Sponsored Presentations - Round 2: EUDAMED Is Mandatory: How to Leverage Your Past Efforts?
Location: Exhibition Hall - Discover!
Speaker: Lionel Tussau – osapiens / BYRD.Health
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Wednesday, May 6th
16:15 - 16:40 WEST
Sponsored Presentations - Round 2: Scaling Regulatory Excellence with AI
Location: Exhibition Hall - Spark!
Speaker: Pearl Vyas, MD, MBA (she/her/hers) – Veeva MedTech
Speaker: Benjamin Rochette – Coloplast
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Thursday, May 7th
09:45 - 10:10 WEST
Sponsored Presentations - Round 1: From Zero to Digital: Efficient Approaches for Technical Documentation Fueled by AI
Location: Exhibition Hall - Spark!
Speaker: Luca Salvatore (he/him/his) – CertHub GmbH
Speaker: Leon Kobinger – CertHub GmbH
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Thursday, May 7th
09:45 - 10:10 WEST
Sponsored Presentations - Round 1:Navigating MDR / IVDR Notified Body Audits: Expectations, Pitfalls, and Practical Insights
Location: Exhibition Hall - Discover!
Speaker: Ludger Moeller (he/him/his) – MDSS GmbH
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Thursday, May 7th
10:15 - 10:40 WEST
Sponsored Presentations - Round 2: Benchmarking the Regulatory Information Management Maturity Curve
Location: Exhibition Hall - Discover!
Speaker: James Gianoutsos – Rimsys Inc.
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Thursday, May 7th
10:15 - 10:40 WEST
Sponsored Presentations - Round 2: Evaluation & Qualification of Novel Technologies in Medicinal Products' Clinical Trials: Another Field of Interaction Between Medtech and Pharma Sectors
Location: Exhibition Hall - Spark!
Speaker: Thierry Sirdey – ProductLife Group
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Thursday, May 7th
13:30 - 13:55 WEST
Sponsored Presentation - Round 1: How to Ensure Data Quality and Reliability in Clinical Trials and PMCF under MDR
Location: Exhibition Hall - Discover!
Speaker: Enrico Perfler – 1MED SA
Speaker: Christine Beulshausen – TÜV SÜD
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Thursday, May 7th
13:30 - 13:55 WEST
Sponsored Presentations - Round 1: CMC Strategy for First-in-Human: A Practical Roadmap for Development
Location: Exhibition Hall - Spark!
Speaker: Sacha Lynch, MSc – QbD Group
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Thursday, May 7th
14:00 - 14:25 WEST
Sponsored Presentations - Round 2: Change Management: NBCG-MED Document on Procedures and Criteria for Notification of Changes under MDR/IVDR
Location: Exhibition Hall - Spark!
Speaker: Pietro Iannì, PharmD – Kiwa Cermet Italia Spa (NB0476)
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Thursday, May 7th
14:00 - 14:25 WEST
Sponsored Presentations - Round 2: Navigating EU MDR Article 117: Regulatory Alignment for Drug–Device Combination Products
Location: Exhibition Hall - Discover!
Speaker: Joseph-Richardson Larbi, MSc – Celegence
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Thursday, May 7th
15:45 - 16:10 WEST
Sponsored Presentations - Round 1: Cybersecurity Without Surprises: Strategies to Avoid Deficiencies and Delays in US and EU Submissions
Location: Exhibition Hall - Spark!
Speaker: Michelle Jump, RAC, MS (she/her/hers) – MedSec LLC
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Thursday, May 7th
15:45 - 16:10 WEST
Sponsored Presentations - Round 1: AI-Driven Product Compliance: Accelerating MedTech Innovation
Location: Exhibition Hall - Discover!
Speaker: David Boutellier – REMATIQ
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