5th Qserve MedTech Conference 2023
Program of day 1
The in-depth program of day one provides two rounds with four various sessions. The topics relate to Qserve’s four business areas; Medical Devices, In Vitro Diagnostics, Global Registrations, and Clinical. The day ends with a final panel which brings the speakers back together to discuss and address topics from the day. On day 1, we are happy to close the day with networking, drinks, and a festive dinner.
Program of 11 October 2023
9:30-9:45 Opening
You will be welcomed to the 5th Qserve MedTech Conference by the Board of Qserve, Jan van Lochem, Gert Bos, and Martin de Bruin.
9:45-11:00 Hot Issues in Europe
In this opening panel, Gert Bos (Qserve Group) will explore the latest developments and hot issues straight from Brussels in a moderated debate.
Gert will be joined by Natascha Cuper (Kiwa).
11:15-12:30 Medical Device Software in the EU
This workshop aims to give an overview of current and upcoming regulations and their impact on medical device manufacturers.
Speaker profiles:
11:15-12:30 IVDR - Lessons Learned and Challenges to Come
The aim of this session is to discuss:
- Greatest pain points from the perspective of a manufacturer. What do I wish I knew at the outset?
- Feedback from notified body reviews greatest pitfalls
- Challenges ahead to meet the transitional arrangements
- Staying on the market – Post-Market surveillance and PMPF plus technical file sampling and changes to devices
Speaker profile:
11:15-12:30 Periodic Updates of the Clinical Evaluation
This session will focus on optimizing the updates from clinical and post-market perspectives. For example, having literature searches and adverse events searches as separate documents could be used for the clinical evaluation and for the PMS/PMCF activities.
Speaker profile:
11:15-12:30 UKCA Strategy
This session will give insight into the requirements for the Great Britain market. Learn what is necessary from a regulatory perspective and what type of effort is required from a quality team.
Speaker profile:
14:15-15:30 Effective Supplier Control and Audits
In this session, you will learn how to effectively control your critical suppliers. Special attention will be given to conducting effective supplier audits.
Speaker profile:
14:15-15:30 IVD Go-To-Market Strategies to Focus on FDA
Traditionally IVD manufacturers entered the EU market before looking at the US and ROW. Extended review timelines are pushing manufacturers to think differently and look at the US first. This session will cover go-to-market strategies and secrets to a successful submission.
Speaker profile:
14:15-15:30 Design of Clinical Studies
This session will focus on how to design a proper clinical study and the importance of involving regulatory knowledge in the design.
Speaker profile:
14:15-15:30 Identification and Traceability
This session will explain more about the upward trend in the traceability of medical devices by using unique device identification.
Speaker profile:
16:00-17:15 Panel Show
The day's final panel will bring the speakers of the various sessions and sessions back together to address the questions from the audience. The following speakers will join host Gert Bos on stage:
-
Giovanni Di Rienzo (Qserve Group)
- Sue Spencer (Qserve Group)
- Armêl Plaine (Qserve Group)
- Agnieszka Schreiber (Qserve Group)
- Colleen Watson (Thermo Fisher)
- Natascha Cuper (Kiwa)
17:15-21:30 Festive evening program
We close the first day of the conference with networking and drinks, followed by a festive dinner and evening program.