Symposium Program
08:00
Registration
08:50
Symposium Opening & Welcome
Danielle Giroud, Symposium Chair & Speaker
09:00
Session 1: Regulatory Overview of the Clinical Evaluation Process
Danielle Giroud, Symposium Chair & Speaker
09:00 - 09:25
Review of EU Regulations Regarding Clinical Evaluation (EU-MDR and Related Guidance Documents)
09:25 - 09:50
Before Starting a Clinical Evaluation Plan - How does Risk Management Relate?
09:50 - 10:15
When to Start the Clinical Evaluation Process in New Product Development
10:15 - 10:30
Discussion/Q&A
10:30
Coffee Break and Networking
11:00
Session 2: Develop a Comprehensive Clinical Evaluation Plan (CEP)
Danielle Giroud, Symposium Chair & Speaker
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 - 12:20
Available Data and Preparing Meaningful Literature Search Protocols and Appraisal Plans
12:20 - 12:30
Discussion/Q&A
12:30
Lunch Break and Networking
14:00
Session 3: Write your Clinical Evaluation Report (CER)
Danielle Giroud, Symposium Chair & Speaker
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
Session 4: Develop PMCF Plan and Other Documents
Danielle Giroud, Symposium Chair & Speaker
16:00 -16:25
Contents of a Post Market Clinical Follow-Up Plan (PMCF)
16:25 - 16:50
How to Determine PMCF Activities - an Overview of the Different Options
16:50 - 17:15
Other Documents such as Summary of Safety and Clinical Performance (SSCP) for Users and SSCP for Patients
17:15 - 17:30
Discussion/Q&A
17:30
End of Day One
08:00
Registration
08:50
Opening Remarks
Danielle Giroud, Symposium Chair & Speaker
09:00
Session 1: Operational Endpoints and Develop Evidence Based Clinical Study Design
Danielle Giroud, Symposium Chair & Speaker
10:30
Coffee Break and Networking
11:00
Session 1 continued: Operational Endpoints and Develop Evidence Based Clinical Study Design
Danielle Giroud, Symposium Chair & Speaker
12:20 - 12:30
Discussion/Q&A
12:30
Lunch Break and Networking
13:30
Session 2: Risk Management Principles While Developing & Conducting Medical Device Clinical Investigations
Danielle Giroud, Symposium Chair & Speaker
14:20 - 14:30
Discussion/Q&A
14:30
Session 3: Review of Overall GCP Requirements According to ISO 14155
Danielle Giroud, Symposium Chair & Speaker
15:30
Coffee Break and Networking
16:00
Session 3 continued: Review of Overall GCP Requirements According to ISO 14155
Danielle Giroud, Symposium Chair & Speaker
16:20- 16:30
Discussion/Q&A
16:30
Discussion & Closing Remarks
