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Wednesday, May 14th
09:40 - 10:10 CEST
Solutions Circle: FDA unannounced audits
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Gert W. Bos, PhD FRAPS – QServe Group
Facilitator: Leo Hovestadt – Elekta
Solutions Circles
Wednesday, May 14th
09:40 - 10:10 CEST
Solutions Circle: Key Considerations for Cdx in Combined Trials Under IVDR
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Maham Ansari, MS, RAC – Precision for Medicine
Solutions Circles
Wednesday, May 14th
09:40 - 10:10 CEST
Solutions Circle: Mastering PSURs: Streamline Your Process for Faster Approvals
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Adam Kijowski, PhD – Geistlich Pharma AG
Solutions Circles
Wednesday, May 14th
09:40 - 10:10 CEST
Solutions Circle Reg Desk: Global Market Expansion: Navigating Multi-market Regulatory Complexities
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Priya Paul, BS, MS, MS (she/her/hers) – RegDesk, Inc.
Solutions Circles
Supported by
Wednesday, May 14th
09:40 - 10:10 CEST
Solutions Circle: The Journey to Becoming RCC Certified!
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Stuart Angell
Solutions Circles
Wednesday, May 14th
10:15 - 10:45 CEST
Solutions Circle: Intended Use: The Foundations of the Medical Device House
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Amie Smirthwaite, BEng, PhD, FRAPS – Osteogen Ltd
Solutions Circles
Wednesday, May 14th
10:15 - 10:45 CEST
Solutions Circle Ketryx Corporation: Put Your Model to the Test—Exploring Off-the-shelf AI for Medical Devices
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Jenn Dixon, P.Eng (she/her/hers) – Ketryx
Solutions Circles
Wednesday, May 14th
10:15 - 10:45 CEST
Solutions Circle: Points to Consider in Deciding on Placebo/active Comparators in Clinical Trials
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Karl-Heinz Huemer, PhD MD (he/him/his) – khhconsulting
Solutions Circles
Wednesday, May 14th
10:15 - 10:45 CEST
Solutions Circle: Structured Dialogue - IVDR - Live Example
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Tom Patten, n/a – GMED Certification Division
Solutions Circles
Wednesday, May 14th
10:15 - 10:45 CEST
Solutions Circle: Surviving the EHDS: A Lifeline
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Cecile E. van der Heijden (she/her/hers) – Axon Lawyers
Solutions Circles
Wednesday, May 14th
13:15 - 13:45 CEST
Solutions Circle: Decreasing Complexity, Defining Regulatory and Evaluation Strategy of LLM Based Functions
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Emilie Santos, PhD (she/her/hers) – Philips Healthcare
Solutions Circles
Wednesday, May 14th
13:15 - 13:45 CEST
Solutions Circle Greenlight Guru: Using Clinical Data for More Than Regulatory Approval
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Páll Johannesson – Greenlight Guru
Solutions Circles
Supported by
Wednesday, May 14th
13:15 - 13:45 CEST
Solutions Circle: Impact of the Battery Regulation (EU) 2023/1542 on Medical Devices
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Christoph Kiesselbach (he/him/his) – Schrack & Partner
Solutions Circles
Wednesday, May 14th
13:15 - 13:45 CEST
Solutions Circle: Key Takeaways from 4 Years of Expert Panel Views to Improve Your IVD Evaluation
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Beatriz Rodriguez Grande, PhD – NAMSA
Solutions Circles
Wednesday, May 14th
13:15 - 13:45 CEST
Solutions Circle: ’Growing Pains’: An Evaluation of Evolving Pediatric Study Regulation in the US and EU
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Sarah Arden, PhD – AstraZeneca
Solutions Circles
Wednesday, May 14th
13:50 - 14:20 CEST
Solutions Circle: Challenges Related to Data in AI Medical Devices in the European Union
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Liliana Teles, PharmD, Msc (she/her/hers) – CRITICAL CATALYST
Solutions Circles
Wednesday, May 14th
13:50 - 14:20 CEST
Solutions Circle: Cybersecurity in Premarket Submissions: US vs. EU Approach
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Taly Vider Cohen – MES Medical Electronic Systems
Solutions Circles
Wednesday, May 14th
13:50 - 14:20 CEST
Solutions Circle: Insight in Motivation: The RA Life Stories That Matter in Healthcare
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Gert W. Bos, PhD FRAPS – QServe Group
Facilitator: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD Medical Health Services
Solutions Circles
Wednesday, May 14th
13:50 - 14:20 CEST
Solutions Circle LexisNexis Reed Tech: Tips and Tricks for Managing Global UDI Submissions
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Robin Schilling – LexisNexis Reed Tech
Solutions Circles
Supported by
Thursday, May 15th
09:40 - 10:10 CEST
Solutions Circle: Decreasing Complexity, Defining Regulatory and Evaluation Strategy of LLM Based Functions
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Emilie Santos, PhD (she/her/hers) – Philips Healthcare
Solutions Circles
Thursday, May 15th
09:40 - 10:10 CEST
Solutions Circle: Impact of the Battery Regulation (EU) 2023/1542 on Medical Devices
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Christoph Kiesselbach (he/him/his) – Schrack & Partner
Solutions Circles
Thursday, May 15th
09:40 - 10:10 CEST
Solutions Circle: Key Takeaways from 4 Years of Expert Panel Views to Improve Your IVD Evaluation
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Beatriz Rodriguez Grande, PhD – NAMSA
Solutions Circles
Thursday, May 15th
09:40 - 10:10 CEST
Solutions Circle: "Growing Pains’: An Evaluation of Evolving Pediatric Study Regulation in the US and EU
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Sarah Arden, PhD – AstraZeneca
Solutions Circles
Thursday, May 15th
10:15 - 10:45 CEST
Solutions Circle: Challenges Related to Data in AI Medical Devices in the European Union
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Liliana Teles, PharmD, Msc (she/her/hers) – CRITICAL CATALYST
Solutions Circles
Thursday, May 15th
10:15 - 10:45 CEST
Solutions Circle: Cybersecurity in Premarket Submissions: US vs. EU Approach
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Taly Vider Cohen – MES Medical Electronic Systems
Solutions Circles
Thursday, May 15th
10:15 - 10:45 CEST
Solutions Circle: Insight in Motivation: The RA Life Stories That Matter in Healthcare
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Gert W. Bos, PhD FRAPS – QServe Group
Facilitator: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD Medical Health Services
Solutions Circles
Thursday, May 15th
13:15 - 13:45 CEST
Solutions Circle: Intended Use: The Foundations of the Medical Device House
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Amie Smirthwaite, BEng, PhD, FRAPS – Osteogen Ltd
Solutions Circles
Thursday, May 15th
13:15 - 13:45 CEST
Solutions Circle: Points to Consider in Deciding on Placebo/active Comparators in Clinical Trials
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Karl-Heinz Huemer, PhD MD (he/him/his) – khhconsulting
Solutions Circles
Thursday, May 15th
13:15 - 13:45 CEST
Solutions Circle: Structured Dialogue - IVDR - Live Example
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Tom Patten, n/a – GMED Certification Division
Solutions Circles
Thursday, May 15th
13:15 - 13:45 CEST
Solutions Circle: Surviving the EHDS: A Lifeline
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Cecile E. van der Heijden (she/her/hers) – Axon Lawyers
Solutions Circles
Thursday, May 15th
13:50 - 14:20 CEST
Solutions Circle: FDA unannounced audits
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Leo Hovestadt – Elekta
Facilitator: Martin de Bruin
Solutions Circles
Thursday, May 15th
13:50 - 14:20 CEST
Solutions Circle: key Considerations for Cdx in Combined Trials Under IVDR
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Maham Ansari, MS, RAC – Precision for Medicine
Solutions Circles
Thursday, May 15th
13:50 - 14:20 CEST
Solutions Circle: Mastering PSURs: Streamline Your Process for Faster Approvals
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Adam Kijowski, PhD – Geistlich Pharma AG
Solutions Circles
Thursday, May 15th
13:50 - 14:20 CEST
Solutions Circle: The Journey to Becoming RCC Certified!
Location: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: Jennifer Neff, PhD – Entourage GmbH
Solutions Circles