Sponsored Presentations - Exhibition Hall

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Wednesday, May 6th
09:40 - 10:10 WEST
Solutions Circle 1: Was SoHO Born From HCT/Ps?
Location: Exhibition Hall
Facilitator: Mark Levi, PhD – RTI
Solutions Circle
Wednesday, May 6th
09:40 - 10:10 WEST
Solutions Circle 2: Early Market Access to Innovative Diagnostics
Location: Exhibition Hall
Facilitator: Nadine Neale, PGDip (she/her/hers) – MHRA
Solutions Circle
Wednesday, May 6th
09:40 - 10:10 WEST
Solutions Circle 3: Building Foundational Skills for Regulators in the Age of Artificial Intelligence
Location: Exhibition Hall
Facilitator: Katy Slater – Komorebi Ltd
Solutions Circle
Wednesday, May 6th
09:40 - 10:10 WEST
Solutions Circle 4: Is Consent the Answer? Exploring Regulatory Options for Non-Compliant Devices in Australia
Location: Exhibition Hall
Facilitator: Kea Dent, MBA, GAICD, RAC (she/her/hers) – KD&A
Solutions Circle
Wednesday, May 6th
09:40 - 10:20 WEST
Solutions Cirle 5: Modernizing Regulatory: What's Working, What's Not, What's Next
Location: Exhibition Hall
Facilitator: Priya Bhutani, BS, MS, MS (she/her/hers) – RegDesk, Inc.
Solutions Circle
Presented by
Wednesday, May 6th
10:15 - 10:45 WEST
Solutions Circle 1: From Paperwork to Digital Compliance: Practical Approaches to Managing Regulatory Documentation
Location: Exhibition Hall
Facilitator: Luca Salvatore (he/him/his) – CertHub GmbH
Speaker: Leon Kobinger – CertHub GmbH
Solutions Circle
Presented by
Wednesday, May 6th
10:15 - 10:45 WEST
Solutions Circle 3: Up, Close and Practical with the European Health Data Space
Location: Exhibition Hall
Facilitator: Cecile E. van der Heijden (she/her/hers) – Axon Lawyers
Solutions Circle
Wednesday, May 6th
10:15 - 10:45 WEST
Solutions Circle 4: Updates on the Battery Regulation (EU) 2023/1542 and Their Impact on Medical Devices
Location: Exhibition Hall
Facilitator: Christoph Kiesselbach (he/him/his) – Schrack & Partner
Solutions Circle
Wednesday, May 6th
10:15 - 10:45 WEST
Solutions Circle 5: RCC Informational Roundtable
Location: Exhibition Hall
Facilitator: Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS
Solutions Circle
Wednesday, May 6th
13:15 - 13:45 WEST
Solutions Circle 1: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)
Location: Exhibition Hall
Presenter: Marta Carnielli – TUV SUD
Solutions Circle
Wednesday, May 6th
13:15 - 13:45 WEST
Solutions Circle 2: The Summary of Safety and Clinical Performance: Enhancing Transparency and Empowering Patients
Location: Exhibition Hall
Facilitator: Susan Partridge, PhD – BSI
Solutions Circle
Wednesday, May 6th
13:15 - 13:45 WEST
Solutions Circle 3: Understanding the Medical Devices Approvals by the Reliance Route in Brazil: Criteria & Benefits
Location: Exhibition Hall
Facilitator: Patricia Luchiari Verrone, Pharmacist (she/her/hers) – Vera Rosas Group
Solutions Circle
Wednesday, May 6th
13:15 - 13:45 WEST
Solutions Circle 4: Are You Really Ready for eCTD 4.0?
Location: Exhibition Hall
Facilitator: Diarmuid Waide – Ennov
Solutions Circle
Wednesday, May 6th
13:15 - 13:45 WEST
Solutions Circle 5: Regulators Are Using AI - Is Your Submission Ready to Be Reviewed by One?
Location: Exhibition Hall
Facilitator: Josh Kim – Artos AI
Solutions Circle
Wednesday, May 6th
13:50 - 14:20 WEST
Solutions Circle 1: Toxicological Thresholds in Chemical Characterization of Medical Devices: Practical Use of DBT, AET, and TSL
Location: Exhibition Hall
Facilitator: Adrien Marchand (he/him/his) – Lucendra SA
Solutions Circle
Wednesday, May 6th
13:50 - 14:20 WEST
Solutions Circle 2: Reliance That Delivers: From WHO Good Reliance Practices to Project Orbis
Location: Exhibition Hall
Facilitator: Hagit Marchaim, PhD, MBA (she/her/hers) – HMC-regulation
Solutions Circle
Wednesday, May 6th
13:50 - 14:20 WEST
Solutions Circle 3: Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges Two Years On
Location: Exhibition Hall
Presenter: Alex Laan (he/him/his) – BSI
Solutions Circle
Wednesday, May 6th
13:50 - 14:20 WEST
Solutions Circle 4: Writing for RAPS
Location: Exhibition Hall
Facilitator: Denise Fulton – RAPS
Facilitator: Kim Young, MSc (she/her/hers) – RAPS
Solutions Circle
Thursday, May 7th
09:40 - 10:10 WEST
Solutions Circle 1: Compliance Amidst Uncertainties for Medical Devices
Location: Exhibition Hall
Facilitator: Gert W. Bos, PhD FRAPS (he/him/his) – QServe Group
Facilitator: Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Solutions Circle
Thursday, May 7th
09:40 - 10:10 WEST
Solutions Circle 2: What the proposed IVDR changes mean for IVD manufacturers
Location: Exhibition Hall
Facilitator: Marta Carnielli – TUV SUD
Facilitator: Tom Patten – GMED
Solutions Circle
Thursday, May 7th
09:40 - 10:10 WEST
Solutions Circle 3: Understanding the Medical Devices Approvals by the Reliance Route in Brazil: Criteria & Benefits
Location: Exhibition Hall
Facilitator: Patricia Luchiari Verrone, Pharmacist (she/her/hers) – Vera Rosas Group
Solutions Circle
Thursday, May 7th
09:40 - 10:10 WEST
Solutions Circle 4: Reliance That Delivers: From WHO Good Reliance Practices to Project Orbis
Location: Exhibition Hall
Facilitator: Hagit Marchaim, PhD, MBA (she/her/hers) – HMC-regulation
Solutions Circle
Thursday, May 7th
10:15 - 10:45 WEST
Solutions Circle 2: The Summary of Safety and Clinical Performance: Enhancing Transparency and Empowering Patients
Location: Exhibition Hall
Facilitator: Susan Partridge, PhD – BSI
Solutions Circle
Thursday, May 7th
10:15 - 10:45 WEST
Solutions Circle 3: Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges Two Years On
Location: Exhibition Hall
Presenter: Alex Laan (he/him/his) – BSI
Solutions Circle
Thursday, May 7th
10:15 - 10:45 WEST
Solutions Circle 4: RCC Informational Roundtable
Location: Exhibition Hall
Facilitator: Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS
Solutions Circle
Thursday, May 7th
10:15 - 10:45 WEST
Solutions Circle 5: Toxicological Thresholds in Chemical Characterization of Medical Devices: Practical Use of DBT, AET, and TSL
Location: Exhibition Hall
Facilitator: Adrien Marchand (he/him/his) – Lucendra SA
Solutions Circle
Thursday, May 7th
13:15 - 13:45 WEST
Solutions Circle 1: When Does a Trend Matter? Practical Approaches to MDR Article 88
Location: Exhibition Hall
Facilitator: Frederike Bruehschwein, MA (she/her/hers) – regular services
Solutions Circle
Thursday, May 7th
13:15 - 13:45 WEST
Solutions Circle 2: Building Foundational Skills for Regulators in the Age of Artificial Intelligence
Location: Exhibition Hall
Facilitator: Katy Slater – Komorebi Ltd
Solutions Circle
Thursday, May 7th
13:15 - 13:45 WEST
Solutions Circle 3: Early Market Access to Innovative Diagnostics
Location: Exhibition Hall
Facilitator: Nadine Neale, PGDip (she/her/hers) – MHRA
Solutions Circle
Thursday, May 7th
13:15 - 13:45 WEST
Solutions Circle 4: Is Consent the Answer? Exploring Regulatory Options for Non-Compliant Devices in Australia
Location: Exhibition Hall
Facilitator: Kea Dent, MBA, GAICD, RAC (she/her/hers) – KD&A
Solutions Circle
Thursday, May 7th
13:15 - 13:45 WEST
Solutions Circle 5: Was SoHO Born From HCT/Ps?
Location: Exhibition Hall
Facilitator: Mark Levi, PhD – RTI
Solutions Circle
Thursday, May 7th
13:50 - 14:20 WEST
Solutions Circle 5: Is Your Quality System Built for Growth or Just for Compliance?
Location: Exhibition Hall
Facilitator: Chris Hayden, MSc – Scilife
Solutions Circle
Presented by
Thursday, May 7th
13:50 - 14:20 WEST
Solutions Circle 1: Updates on the Battery Regulation (EU) 2023/1542 and Their Impact on Medical Devices
Location: Exhibition Hall
Facilitator: Christoph Kiesselbach (he/him/his) – Schrack & Partner
Solutions Circle
Thursday, May 7th
13:50 - 14:20 WEST
Solutions Circle 2: Up, Close and Practical with the European Health Data Space
Location: Exhibition Hall
Facilitator: Cecile E. van der Heijden (she/her/hers) – Axon Lawyers
Solutions Circle
Thursday, May 7th
13:50 - 14:20 WEST
Solutions Circle 3: The Pitfalls of Only Applying ISO 14971:2019 When Applying for MDR
Location: Exhibition Hall
Facilitator: Beatriz Rodriguez Grande, PhD – NAMSA
Solutions Circle
Thursday, May 7th
13:50 - 14:20 WEST
Solutions Circle 4: Regulators Are Using AI - Is Your Submission Ready to Be Reviewed by One?
Location: Exhibition Hall
Facilitator: Josh Kim – Artos AI
Solutions Circle
Friday, May 8th
10:10 - 10:40 WEST
Solutions Circle 1: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)
Location: Exhibition Hall
Presenter: Marta Carnielli – TUV SUD
Solutions Circle
Friday, May 8th
10:10 - 10:40 WEST
Solutions Circle 2: Compliance Amidst Uncertainties for Medical Devices
Location: Exhibition Hall
Facilitator: Gert W. Bos, PhD FRAPS (he/him/his) – QServe Group
Facilitator: Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Solutions Circle
Friday, May 8th
10:10 - 10:40 WEST
Solutions Circle 3: The Pitfalls of Only Applying ISO 14971:2019 When Applying for MDR
Location: Exhibition Hall
Facilitator: Beatriz Rodriguez Grande, PhD – NAMSA
Solutions Circle
Friday, May 8th
10:45 - 11:15 WEST
Solutions Circle 1: What the proposed IVDR changes mean for IVD manufacturers
Location: Exhibition Hall
Facilitator: Marta Carnielli – TUV SUD
Facilitator: Tom Patten – GMED
Solutions Circle
Friday, May 8th
10:45 - 11:15 WEST
Solutions Circle 2: Are You Really Ready for eCTD 4.0?
Location: Exhibition Hall
Facilitator: Diarmuid Waide – Ennov
Solutions Circle
Friday, May 8th
10:45 - 11:15 WEST
Solutions Circle 3: When Does a Trend Matter? Practical Approaches to MDR Article 88
Location: Exhibition Hall
Facilitator: Frederike Bruehschwein, MA (she/her/hers) – regular services
Solutions Circle