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SYMPOSIUM PROGRAM


26 June 2023 27 June 2023
08:00
Registration

08:50
Symposium Opening & Welcome
Danielle Giroud, Conference Chair

09:00
Regulatory Overview of the Clinical Evaluation Process
09:00 - 09:30
Review of EU Regulations Regarding Clinical Evaluation (EU-MDR and Related
Guidance Documents)

09:30 - 10:00
Before Starting a Clinical Evaluation Plan - How does Risk Management Relate?

10:00 - 10:30
When to Start the Clinical Evaluation Process in New Product Development

10:30
Coffee Break and Networking

11:00
Develop a Comprehensive Clinical Evaluation Plan (CEP)
11:00 - 11:20
Contents of a Clinical Evaluation Plan

11:20 - 11:40
Quantified Claims (safety, Performance and Clinical Benefits)

11:40 - 12:00
Position your Device

12:00 - 12:30
Available Data and Preparing Meaningful Literature Search Protocols and
Appraisal Plans

12:30
Lunch Break and Networking

14:00
Write your Clinical Evaluation Report (CER)
14:00 - 14:20
Clinical Development Plan

14:20 - 14:40
Contents of a Clinical Evaluation Report

14:40 - 15:00
Analysis of the Different Data Sets

15:00 - 15:15
Discussion and Conclusions

15:15 - 15:30
What's Next - the PMCF Plan and PMS Plan

15:30
Coffee Break and Networking

16:00
Develop PMCF Plan and Other Documents
16:00 -16:30
Contents of a Post Market Clinical Follow-Up Plan (PMCF)

16:30 - 17:00
How to Determine PMCF Activities - an Overview of the Different Options

17:00 - 17:30
Other Documents such as Summary of Safety and Clinical Performance (SSCP) for
Users and SSCP for Patients

17:30
End of Day One

08:00
Registration

08:50
Introduction - Writing Effective Clinical Investigation Plan and Implement a
Compliant Study According to ISO 14155 and Ensure Regulatory Compliance WW

09:00
Operational Endpoints and Develop Evidence Based Clinical Study Design

10:30
Coffee Break and Networking

11:00
Operational Endpoints and Develop Evidence Based Clinical Study Design (cont.)

12:30
Lunch Break and Networking

13:30
Risk Management Principles While Developing and Conducting Medical Device
Clinical Investigations

14:30
Review of Overall GCP Requirements According to ISO 14155

15:30
Coffee Break and Networking

16:00
Review of Overall GCP Requirements According to ISO 14155 (cont.)

16:30
Discussion & Closing Remarks



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