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Solutions Circles - Exhibition Hall
Join fellow attendees and industry experts in these small group discussions to exchange ideas and tackle regulatory challenges together.
Know Before You Go & Participation Guidelines:
• Ticket Pick-up: Get your ticket at the Solutions Circle check-in desk at least 15 minutes before the session. Seating is limited to 20 and available first-come, first-served.
• Participation: Seats are held only for 3 minutes after the session begins, then released to standby attendees. Please exit promptly at the end; seats cannot be saved between sessions.
• Full Conference Badge Required: Solutions Circles are open to full-conference registrants only. Please have your badge ready to show.
*Programme and presenters subject to change. Please check back frequently for updates.
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Wednesday, May 6th
09:40 - 10:10 WESTSolutions Circle 1: Was SoHO Born From HCT/Ps?Location: Exhibition Hall
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Wednesday, May 6th
09:40 - 10:10 WESTSolutions Circle 2: Early Market Access to Innovative DiagnosticsLocation: Exhibition Hall
Facilitator: – Medicines and Healthcare Products Regulatory Agency
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Wednesday, May 6th
09:40 - 10:10 WESTSolutions Circle 3: Building Foundational Skills for Regulators in the Age of Artificial IntelligenceLocation: Exhibition Hall
Facilitator: – Komorebi Ltd
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Wednesday, May 6th
09:40 - 10:10 WESTSolutions Circle 4: Is Consent the Answer? Exploring Regulatory Options for Non-Compliant Devices in AustraliaLocation: Exhibition Hall
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Wednesday, May 6th
09:40 - 10:20 WESTSolutions Cirle 5: Modernizing Regulatory: What's Working, What's Not, What's NextLocation: Exhibition Hall
Facilitator: – RegDesk, Inc.
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Wednesday, May 6th
10:15 - 10:45 WESTSolutions Circle 1: From Paperwork to Digital Compliance: Practical Approaches to Managing Regulatory DocumentationLocation: Exhibition Hall
Facilitator: – CertHub GmbH
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Wednesday, May 6th
10:15 - 10:45 WESTSolutions Circle 3: Up, Close and Practical with the European Health Data SpaceLocation: Exhibition Hall
Facilitator: – Axon Lawyers
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Wednesday, May 6th
10:15 - 10:45 WESTSolutions Circle 4: Updates on the Battery Regulation (EU) 2023/1542 and Their Impact on Medical DevicesLocation: Exhibition Hall
Facilitator: – Schrack & Partner
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Wednesday, May 6th
10:15 - 10:45 WESTSolutions Circle 5: RCC Informational RoundtableLocation: Exhibition Hall
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Wednesday, May 6th
13:15 - 13:45 WESTSolutions Circle 1: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)Location: Exhibition Hall
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Wednesday, May 6th
13:15 - 13:45 WESTSolutions Circle 2: The Summary of Safety and Clinical Performance: Enhancing Transparency and Empowering PatientsLocation: Exhibition Hall
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Wednesday, May 6th
13:15 - 13:45 WESTSolutions Circle 3: Understanding the Medical Devices Approvals by the Reliance Route in Brazil: Criteria & BenefitsLocation: Exhibition Hall
Facilitator: – Vera Rosas Group
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Wednesday, May 6th
13:15 - 13:45 WESTSolutions Circle 4: Are You Really Ready for eCTD 4.0?Location: Exhibition Hall
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Wednesday, May 6th
13:15 - 13:45 WESTSolutions Circle 5: Regulators Are Using AI - Is Your Submission Ready to Be Reviewed by One?Location: Exhibition Hall
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Wednesday, May 6th
13:50 - 14:20 WESTSolutions Circle 1: Toxicological Thresholds in Chemical Characterization of Medical Devices: Practical Use of DBT, AET, and TSLLocation: Exhibition Hall
Facilitator: – Lucendra SA
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Wednesday, May 6th
13:50 - 14:20 WESTSolutions Circle 2: Reliance That Delivers: From WHO Good Reliance Practices to Project OrbisLocation: Exhibition Hall
Facilitator: – HMC-regulation
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Wednesday, May 6th
13:50 - 14:20 WESTSolutions Circle 3: Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges Two Years OnLocation: Exhibition Hall
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Wednesday, May 6th
13:50 - 14:20 WESTSolutions Circle 4: Writing for RAPSLocation: Exhibition Hall
Facilitator: – RAPS
Facilitator: – RAPS
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Thursday, May 7th
09:40 - 10:10 WESTSolutions Circle 1: Compliance Amidst Uncertainties for Medical DevicesLocation: Exhibition Hall
Facilitator: – QServe Group
Facilitator: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
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Thursday, May 7th
09:40 - 10:10 WESTSolutions Circle 2: What the proposed IVDR changes mean for IVD manufacturersLocation: Exhibition Hall
Facilitator: – TUV SUD
Facilitator: – GMED
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Thursday, May 7th
09:40 - 10:10 WESTSolutions Circle 3: Understanding the Medical Devices Approvals by the Reliance Route in Brazil: Criteria & BenefitsLocation: Exhibition Hall
Facilitator: – Vera Rosas Group
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Thursday, May 7th
09:40 - 10:10 WESTSolutions Circle 4: Reliance That Delivers: From WHO Good Reliance Practices to Project OrbisLocation: Exhibition Hall
Facilitator: – HMC-regulation
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Thursday, May 7th
10:15 - 10:45 WESTSolutions Circle 1: Is Your Quality System Built for Growth or Just for Compliance?Location: Exhibition Hall
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Thursday, May 7th
10:15 - 10:45 WESTSolutions Circle 2: The Summary of Safety and Clinical Performance: Enhancing Transparency and Empowering PatientsLocation: Exhibition Hall
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Thursday, May 7th
10:15 - 10:45 WESTSolutions Circle 3: Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges Two Years OnLocation: Exhibition Hall
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Thursday, May 7th
10:15 - 10:45 WESTSolutions Circle 4: RCC Informational RoundtableLocation: Exhibition Hall
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Thursday, May 7th
10:15 - 10:45 WESTSolutions Circle 5: Toxicological Thresholds in Chemical Characterization of Medical Devices: Practical Use of DBT, AET, and TSLLocation: Exhibition Hall
Facilitator: – Lucendra SA
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Thursday, May 7th
13:15 - 13:45 WESTSolutions Circle 1: When Does a Trend Matter? Practical Approaches to MDR Article 88Location: Exhibition Hall
Facilitator: – regular services
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Thursday, May 7th
13:15 - 13:45 WESTSolutions Circle 2: Building Foundational Skills for Regulators in the Age of Artificial IntelligenceLocation: Exhibition Hall
Facilitator: – Komorebi Ltd
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Thursday, May 7th
13:15 - 13:45 WESTSolutions Circle 3: Early Market Access to Innovative DiagnosticsLocation: Exhibition Hall
Facilitator: – Medicines and Healthcare Products Regulatory Agency
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Thursday, May 7th
13:15 - 13:45 WESTSolutions Circle 4: Is Consent the Answer? Exploring Regulatory Options for Non-Compliant Devices in AustraliaLocation: Exhibition Hall
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Thursday, May 7th
13:15 - 13:45 WESTSolutions Circle 5: Was SoHO Born From HCT/Ps?Location: Exhibition Hall
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Thursday, May 7th
13:50 - 14:20 WESTSolutions Circle 1: Updates on the Battery Regulation (EU) 2023/1542 and Their Impact on Medical DevicesLocation: Exhibition Hall
Facilitator: – Schrack & Partner
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Thursday, May 7th
13:50 - 14:20 WESTSolutions Circle 2: Up, Close and Practical with the European Health Data SpaceLocation: Exhibition Hall
Facilitator: – Axon Lawyers
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Thursday, May 7th
13:50 - 14:20 WESTSolutions Circle 3: The Pitfalls of Only Applying ISO 14971:2019 When Applying for MDRLocation: Exhibition Hall
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Thursday, May 7th
13:50 - 14:20 WESTSolutions Circle 4: Regulators Are Using AI - Is Your Submission Ready to Be Reviewed by One?Location: Exhibition Hall
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Friday, May 8th
10:10 - 10:40 WESTSolutions Circle 1: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)Location: Exhibition Hall
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Friday, May 8th
10:10 - 10:40 WESTSolutions Circle 2: Compliance Amidst Uncertainties for Medical DevicesLocation: Exhibition Hall
Facilitator: – QServe Group
Facilitator: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
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Friday, May 8th
10:10 - 10:40 WESTSolutions Circle 3: The Pitfalls of Only Applying ISO 14971:2019 When Applying for MDRLocation: Exhibition Hall
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Friday, May 8th
10:45 - 11:15 WESTSolutions Circle 1: What the proposed IVDR changes mean for IVD manufacturersLocation: Exhibition Hall
Facilitator: – TUV SUD
Facilitator: – GMED
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Friday, May 8th
10:45 - 11:15 WESTSolutions Circle 2: Are You Really Ready for eCTD 4.0?Location: Exhibition Hall
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Friday, May 8th
10:45 - 11:15 WESTSolutions Circle 3: When Does a Trend Matter? Practical Approaches to MDR Article 88Location: Exhibition Hall
Facilitator: – regular services
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