5th Qserve MedTech Conference 2023
Program of day 2
After the word of welcome, we start the day by presenting the hot issues outside Europe, a follow-up of the subject on day 1. On day 2, again, you can join one of four parallel sessions with in-depth information and experiences from the field. After your registration, you will soon receive an email from the Marketing team in which you can customize your program and select your preferences for the sessions to attend.
The round table discussion finishes with a Q&A with the audience, and Gert Bos will close the day on stage with a final panel discussion with some of our internal and external speakers.
Program of 12 October 2023
You will be welcomed to the 5th Qserve MedTech Conference by the Board of Qserve, Jan van Lochem, Gert Bos, and Gert Bos.
9:15-10:00 Hot Issues Outside of Europa
In this opening panel, Gert Bos (Qserve Group) will be exploring the latest developments and hot issues arising in the context of global regulatory compliance in a moderated debate.
Gert will be joined by Daniëlle Motta (Qserve Grou).
10:30-12:15 Quantitative Benefit-Risk Assessment
This session will cover aspects of quantitative benefit-risk assessment. Fundamentals of benefit-risk assessment will be covered. Topics covered will include methods for Defining Indicators & Threshold Values for Benefit-Risk Analysis, justifying risk acceptability criteria, presentation of quantitative risk in SSCPs, and ways to define specific and measurable clinical outcomes.
10:30-12:15 Companion Diagnostics Challenges for Pharma and Diagnostic Partners to Work Together
Companion diagnostics and personalized medicine is a rapidly evolving science. The approaches in the US and EU are different and there are overlaps with several other topics.
10:30-12:15 Post-Market Clinical Follow-Up: How to Create and Maintain an Efficient Long-Term Strategy
This workshop will focus on how manufacturers can effectively collect long-term proactive PMCF data. PMCF surveys, but also other options to collect data will be discussed.
10:30-12:15 Market Access Beyond the EU and US Market
This session will focus on entering the global market with the use of EU/US approval. Several countries in Asia, South/Latin America, and MEA recognize EU/US approval for in-country registrations. Manufacturers will learn how to adjust their technical documentation in such a way that it can be used for submission to the competent authority. We will also address the substantial differences that need to be considered when additional clinical testing is required.
13:45-14:15 Parallel Track
During the Parallel Track, our speakers will exchange views and experiences on two topics. The tracks finish with a Q&A with the audience.
Writing For Lay Users: Tips and Tricks
Writing documents for lay users, such as informed consent forms, instructions for use, and a summary of safety and clinical performance can be challenging. This session will use examples to explain the importance of targeting your audience. The session also aims to provide you with tips and tricks on how to write best for lay users.
This track will be hosted by Bianca Lutters (Qserve Group) and Stan Geurts (De Hulpdoker).
SSCP: How to Present Your Data, and What Information to Disclose
In the Summary of Safety and Clinical Performance (SSCP), a manufacturer must provide information to support that the device is safe and performs as intended. As the SSCP is a publicly available document, it is important to ensure that no proprietary information is disclosed if not required by the Medical Devices Regulation (EU) 2017/745 (MDR). This session will provide an overview of the information required to be presented in the SSCP and discuss best practices on how to present the data, including options to limit the disclosure of proprietary information.
15:00-16:15 Panel Show
The final panel of the day will bring the speakers of the various sessions and sessions back together in some exchange of views and in addressing the questions the audience will have at this stage. The following speakers will join host Gert Bos
16:15-18:30 Networking and Drinks
We end the conference with networking and drinks.
Day 1 | 11 October 2023
Discover the program of day 1.
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Day 2 | 12 October 2023
Discover the program of day 2.
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Day 3 | 13 October 2023
Discover the program of day 3.
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We are pleased to welcome you to Novotel Amsterdam Schiphol Airport. Read more information about the hotel, transport possibilities or book your hotel room.
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Our program will be hosted by Qserve’s internal hosts and external speakers from the field. Get to know the professionals from the industry, NBs, and Competent Authorities.
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Register for the event
Join us in Amsterdam on the 11th, 12th, and/or 13th of October.
We look forward to seeing you in Amsterdam in October!
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