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Solutions Circles

*Programme and presenters subject to change. Please check back frequently for updates.

  • Wednesday, May 6th
    09:40 - 10:10 WEST
    Solutions Circle: Building Foundational Skills for Regulators in the Age of Artificial Intelligence
    Facilitator: Katy Slater – Komorebi Ltd
    Solutions Circle
  • Wednesday, May 6th
    09:40 - 10:10 WEST
    Solutions Circle: Early Market Access to Innovative Diagnostics
    Facilitator: Nadine Neale – Medicines and Healthcare Products Regulatory Agency
    Solutions Circle
  • Wednesday, May 6th
    09:40 - 10:10 WEST
    Solutions Circle: Is Consent the Answer? Exploring Regulatory Options for Non-Compliant Devices in Australia
    Solutions Circle
  • Wednesday, May 6th
    09:40 - 10:10 WEST
    Solutions Circle: Was SoHO Born From HCT/Ps?
    Facilitator: Mark Levi, PhD – RTI
    Solutions Circle
  • Wednesday, May 6th
    10:15 - 10:45 WEST
    Solutions Circle: RCC Informational Roundtable
    Solutions Circle
  • Wednesday, May 6th
    10:15 - 10:45 WEST
    Solutions Circle: Up, Close and Practical with the European Health Data Space
    Facilitator: Cecile E. van der Heijden (she/her/hers) – Axon Lawyers
    Solutions Circle
  • Wednesday, May 6th
    10:15 - 10:45 WEST
    Solutions Circle: Regulators Are Using AI — Is Your Submission Ready to Be Reviewed by One?
    Facilitator: Josh Kim – Artos AI
    Solutions Circle
  • Wednesday, May 6th
    10:15 - 10:45 WEST
    Solutions Circle: Updates on the Battery Regulation (EU) 2023/1542 and Their Impact on Medical Devices
    Facilitator: Christoph Kiesselbach (he/him/his) – Schrack & Partner
    Solutions Circle
  • Wednesday, May 6th
    13:15 - 13:45 WEST
    Solutions Circle: Are You Really Ready for eCTD 4.0?
    Facilitator: Diarmuid Waide – Ennov
    Solutions Circle
  • Wednesday, May 6th
    13:15 - 13:45 WEST
    Solutions Circle: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)
    Presenter: Marta Carnielli – TUV Sud Product Service GmbH
    Solutions Circle
  • Wednesday, May 6th
    13:15 - 13:45 WEST
    Solutions Circle: The Summary of Safety and Clinical Performance: Enhancing Transparency and Empowering Patients
    Solutions Circle
  • Wednesday, May 6th
    13:15 - 13:45 WEST
    Solutions Circle: Understanding the Medical Devices Approvals by the Reliance Route in Brazil: Criteria & Benefits
    Solutions Circle
  • Wednesday, May 6th
    13:50 - 14:20 WEST
    Solutions Circle: Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges Two Years On
    Presenter: Alex Laan (he/him/his) – BSI
    Solutions Circle
  • Wednesday, May 6th
    13:50 - 14:20 WEST
    Solutions Circle: Toxicological Thresholds in Chemical Characterization of Medical Devices: Practical Use of DBT, AET, and TSL
    Facilitator: Adrien Marchand (he/him/his) – Lucendra SA
    Solutions Circle
  • Wednesday, May 6th
    13:50 - 14:20 WEST
    Solutions Circle: Writing for RAPS
    Facilitator: Denise Fulton – RAPS
    Facilitator: Kim Young, MSc (she/her/hers) – RAPS
    Solutions Circle
  • Thursday, May 7th
    10:15 - 10:45 WEST
    Solutions Circle: Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges Two Years On
    Presenter: Alex Laan (he/him/his) – BSI
    Solutions Circle
  • Thursday, May 7th
    10:15 - 10:45 WEST
    Solutions Circle: RCC Informational Roundtable
    Solutions Circle
  • Thursday, May 7th
    10:15 - 10:45 WEST
    Solutions Circle: Toxicological Thresholds in Chemical Characterization of Medical Devices: Practical Use of DBT, AET, and TSL
    Facilitator: Adrien Marchand (he/him/his) – Lucendra SA
    Solutions Circle
  • Thursday, May 7th
    13:15 - 13:45 WEST
    Solutions Circle: Building Foundational Skills for Regulators in the Age of Artificial Intelligence
    Facilitator: Katy Slater – Komorebi Ltd
    Solutions Circle
  • Thursday, May 7th
    13:15 - 13:45 WEST
    Solutions Circle: Early Market Access to Innovative Diagnostics
    Facilitator: Nadine Neale – Medicines and Healthcare Products Regulatory Agency
    Solutions Circle
  • Thursday, May 7th
    13:15 - 13:45 WEST
    Solutions Circle: Is Consent the Answer? Exploring Regulatory Options for Non-Compliant Devices in Australia
    Solutions Circle
  • Thursday, May 7th
    13:15 - 13:45 WEST
    Solutions Circle: Was SoHO Born From HCT/Ps?
    Facilitator: Mark Levi, PhD – RTI
    Solutions Circle
  • Thursday, May 7th
    13:50 - 14:20 WEST
    Solutions Circle: Regulators Are Using AI — Is Your Submission Ready to Be Reviewed by One?
    Facilitator: Josh Kim – Artos AI
    Solutions Circle
  • Thursday, May 7th
    13:50 - 14:20 WEST
    Solutions Circle: The Pitfalls of Only Applying ISO 14971:2019 When Applying for MDR
    Facilitator: Rachel K. Gibbs – NAMSA
    Solutions Circle
  • Thursday, May 7th
    13:50 - 14:20 WEST
    Solutions Circle: Up, Close and Practical with the European Health Data Space
    Facilitator: Cecile E. van der Heijden (she/her/hers) – Axon Lawyers
    Solutions Circle
  • Thursday, May 7th
    13:50 - 14:20 WEST
    Solutions Circle: Updates on the Battery Regulation (EU) 2023/1542 and Their Impact on Medical Devices
    Facilitator: Christoph Kiesselbach (he/him/his) – Schrack & Partner
    Solutions Circle
  • Friday, May 8th
    10:10 - 10:40 WEST
    Solutions Circle: The Pitfalls of Only Applying ISO 14971:2019 When Applying for MDR
    Facilitator: Rachel K. Gibbs – NAMSA
    Solutions Circle
  • Friday, May 8th
    10:45 - 11:15 WEST
    Solutions Circle: Compliance Amidst Uncertainties for Medical Devices
    Facilitator: Gert BQ Bos, MSc, PhD, FRAPS – Qserve Group
    Facilitator: Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH
    Solutions Circle