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Solutions Circles
*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: Building Foundational Skills for Regulators in the Age of Artificial IntelligenceLocation: Exhibition - Hall 2
Facilitator: – Komorebi Ltd
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Wednesday, May 6th
09:40 - 10:10 WESTSolutions Circle: Early Market Access to Innovative DiagnosticsLocation: Exhibition - Hall 2
Facilitator: – Medicines and Healthcare Products Regulatory Agency
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Wednesday, May 6th
09:40 - 10:10 WESTSolutions Circle: Is Consent the Answer? Exploring Regulatory Options for Non-Compliant Devices in AustraliaLocation: Exhibition - Hall 2
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Wednesday, May 6th
09:40 - 10:10 WESTSolutions Circle: Was SoHO Born From HCT/Ps?Location: Exhibition - Hall 2
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Wednesday, May 6th
09:40 - 10:20 WESTSolutions Cirle: RegdeskLocation: Exhibition - Hall 2
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Wednesday, May 6th
10:15 - 10:45 WESTSolutions Circle: RCC Informational RoundtableLocation: Exhibition - Hall 2
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Wednesday, May 6th
10:15 - 10:45 WESTSolutions Circle: Up, Close and Practical with the European Health Data SpaceLocation: Exhibition - Hall 2
Facilitator: – Axon Lawyers
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Wednesday, May 6th
10:15 - 10:45 WESTSolutions Circle: Regulators Are Using AI — Is Your Submission Ready to Be Reviewed by One?Location: Exhibition - Hall 2
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Wednesday, May 6th
10:15 - 10:45 WESTSolutions Circle: Updates on the Battery Regulation (EU) 2023/1542 and Their Impact on Medical DevicesLocation: Exhibition - Hall 2
Facilitator: – Schrack & Partner
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Wednesday, May 6th
13:15 - 13:45 WESTSolutions Circle: Are You Really Ready for eCTD 4.0?Location: Exhibition - Hall 2
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Wednesday, May 6th
13:15 - 13:45 WESTSolutions Circle: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)Location: Exhibition - Hall 2
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Wednesday, May 6th
13:15 - 13:45 WESTSolutions Circle: The Summary of Safety and Clinical Performance: Enhancing Transparency and Empowering PatientsLocation: Exhibition - Hall 2
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Wednesday, May 6th
13:15 - 13:45 WESTSolutions Circle: Understanding the Medical Devices Approvals by the Reliance Route in Brazil: Criteria & BenefitsLocation: Exhibition - Hall 2
Facilitator: – Vera Rosas Group
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Wednesday, May 6th
13:50 - 14:20 WESTSolutions Circle: Reliance That Delivers: From WHO Good Reliance Practices to Project OrbisLocation: Exhibition - Hall 2
Facilitator: – HMC-regulation
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Wednesday, May 6th
13:50 - 14:20 WESTSolutions Circle: Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges Two Years OnLocation: Exhibition - Hall 2
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Wednesday, May 6th
13:50 - 14:20 WESTSolutions Circle: Toxicological Thresholds in Chemical Characterization of Medical Devices: Practical Use of DBT, AET, and TSLLocation: Exhibition - Hall 2
Facilitator: – Lucendra SA
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Thursday, May 7th
09:40 - 10:10 WESTSolutions Circle: Compliance Amidst Uncertainties for Medical DevicesLocation: Exhibition - Hall 2
Facilitator: – QServe
Facilitator: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
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Thursday, May 7th
09:40 - 10:10 WESTSolutions Circle: Reliance That Delivers: From WHO Good Reliance Practices to Project OrbisLocation: Exhibition - Hall 2
Facilitator: – HMC-regulation
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Thursday, May 7th
09:40 - 10:10 WESTSolutions Circle: What the proposed IVDR changes mean for IVD manufacturers?Location: Exhibition - Hall 2
Facilitator: – TUV SUD
Facilitator: – GMED
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Thursday, May 7th
09:40 - 10:10 WESTSolutions Circle: Understanding the Medical Devices Approvals by the Reliance Route in Brazil: Criteria & BenefitsLocation: Exhibition - Hall 2
Facilitator: – Vera Rosas Group
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Thursday, May 7th
10:15 - 10:45 WESTSolutions Circle: Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges Two Years OnLocation: Exhibition - Hall 2
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Thursday, May 7th
10:15 - 10:45 WESTSolutions Circle: Scilife -
Thursday, May 7th
10:15 - 10:45 WESTSolutions Circle: RCC Informational RoundtableLocation: Exhibition - Hall 2
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Thursday, May 7th
10:15 - 10:45 WESTSolutions Circle: The Summary of Safety and Clinical Performance: Enhancing Transparency and Empowering PatientsLocation: Exhibition - Hall 2
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Thursday, May 7th
10:15 - 10:45 WESTSolutions Circle: Toxicological Thresholds in Chemical Characterization of Medical Devices: Practical Use of DBT, AET, and TSLLocation: Exhibition - Hall 2
Facilitator: – Lucendra SA
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Thursday, May 7th
13:15 - 13:45 WESTSolutions Circle: Building Foundational Skills for Regulators in the Age of Artificial IntelligenceLocation: Exhibition - Hall 2
Facilitator: – Komorebi Ltd
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Thursday, May 7th
13:15 - 13:45 WESTSolutions Circle: Early Market Access to Innovative DiagnosticsLocation: Exhibition - Hall 2
Facilitator: – Medicines and Healthcare Products Regulatory Agency
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Thursday, May 7th
13:15 - 13:45 WESTSolutions Circle: Is Consent the Answer? Exploring Regulatory Options for Non-Compliant Devices in AustraliaLocation: Exhibition - Hall 2
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Thursday, May 7th
13:15 - 13:45 WESTSolutions Circle: Was SoHO Born From HCT/Ps?Location: Exhibition - Hall 2
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Thursday, May 7th
13:50 - 14:20 WESTSolutions Circle: The Pitfalls of Only Applying ISO 14971:2019 When Applying for MDRLocation: Exhibition - Hall 2
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Thursday, May 7th
13:50 - 14:20 WESTSolutions Circle: Regulators Are Using AI — Is Your Submission Ready to Be Reviewed by One?Location: Exhibition - Hall 2
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Thursday, May 7th
13:50 - 14:20 WESTSolutions Circle: Up, Close and Practical with the European Health Data SpaceLocation: Exhibition - Hall 2
Facilitator: – Axon Lawyers
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Thursday, May 7th
13:50 - 14:20 WESTSolutions Circle: Updates on the Battery Regulation (EU) 2023/1542 and Their Impact on Medical DevicesLocation: Exhibition - Hall 2
Facilitator: – Schrack & Partner
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Friday, May 8th
10:10 - 10:40 WESTSolutions Circle: CertHub GmbHLocation: Exhibition - Hall 2
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Friday, May 8th
10:10 - 10:40 WESTSolutions Circle: Compliance Amidst Uncertainties for Medical DevicesLocation: Exhibition - Hall 2
Facilitator: – QServe
Facilitator: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
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Friday, May 8th
10:10 - 10:40 WESTSolutions Circle: The Pitfalls of Only Applying ISO 14971:2019 When Applying for MDRLocation: Exhibition - Hall 2
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Friday, May 8th
10:10 - 10:40 WESTSolutions Circle: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)Location: Exhibition - Hall 2
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Friday, May 8th
10:45 - 11:15 WESTSolutions Circle: What the proposed IVDR changes mean for IVD manufacturers?Location: Exhibition - Hall 2
Facilitator: – TUV SUD
Facilitator: – GMED
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Friday, May 8th
10:45 - 11:15 WESTSolutions Circle: Are You Really Ready for eCTD 4.0?Location: Exhibition - Hall 2
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