Qarad IVDR conference 2022

Our 6th annual Qarad IVDR Conference is approaching and will take place at NHOW Brussels on October 11-13, 2022. We hope you are as excited as we are about the new edition, because we have some big news to share. This year, we will offer a three-day conference, adding a pre-conference workshop to our two-day conference. Moreover, the 6th edition will highlight a lot of new information based on our experience and focus on new guidance documents

Previous editions have been a big success with participants from all over the world, including China, USA, Canada and many European countries. We are looking forward to further build on that success during our first three-day conference. 

Practical

  • WHERE? NHOW Brussels hotel

    NHOW Brussels  
    Rue Royale 250
    1210 Brussels

  • WHEN? October 11-13, 2022 (3 full days from 9.00h – 17.30h) 

  • PRICES?
    – €800 for Pre-Conference Workshop (Oct 11)
    – €1000 for Conference Day 1 or 2 (Oct 12 or 13)
    – €1600 for Conference (Oct 12 & 13)
    – €2000 for Pre-Conference Workshop & Conference (Oct 11, 12 & 13)

    All prices are VAT exclusive (VAT not applicable for payments coming from outside of Belgium).

NEW: Pre-conference workshop (October 11)

The additional workshop will take place on October 11, and is specifically designed to provide a good overview of the fundamentals of the IVDR. It is particularly suited for regulatory professionals who are new to the IVDR. This workshop could help you prepare for the following 2 conference days, or could be considered as a stand-alone workshop. 

Conference on IVD Regulation 2017/746: new insights! (October 12-13)

During the two conference days (October 12 and 13), our Qarad experts and invited speakers will touch upon various new aspects of the IVDR. We tackle the regulation in-depth from a theoretical point-of-view, but thanks to our wealth of experience, we are also able to share the newest insights, interpretations and real-life examples. Moreover, there will be an important focus on new guidance documents

Conference Agenda*

Day 1
  • Regulatory state-of-play: what’s new and what’s coming?
  • Classification challenges and complex cases
  • The art of risk management and clinical benefit assessment
  • A practical approach on how to meet the various elements of clinical evidence under the IVDR, including scientific validity, state-of-the-art and performance evaluation plans and reports
  • How to set-up and document your clinical performance evaluation studies in compliance with the IVDR?
  • How good design control can help you address regulatory requirements
  • Requirements imposed on IVD devices used in clinical trials
  • Impact of the IVDR on laboratories
  • Challenges and opportunities experienced when complying to the IVDR – an industry perspective
Day 2
  • A Notified Body’s point of view
  • How to build compliant pre- and post-market documentation?
  • Documentation required for Software under the IVDR
  • How to address PMS and PMPF requirements for both IVDR compliant and legacy devices?
  • Electronic IFUs: what is required and what is the impact on your organisation?
  • EUDAMED: what can and what should you already do?
  • The art of assigning Basic-UDI-DIs and UDI-DIs
  • Best practice on managing the economic operators within your supply chain
  • The Impact of the IVDR on your Quality Management System
  • How to ensure continued access to the UK and Swiss market?

*This is a temporary agenda, which is still subject to change.

Meet Our Guest Speakers*

Steve Chatters
Steve Chatters – EVP Regulatory, Medical and Quality Affairs at OGT (a Sysmex company) 

Before joining OGT six years ago, Steve Chatters was a Clinical Scientist running specialist cancer diagnostic laboratories. 

At the Qarad IVDR Conference 2022, he will talk about challenges and opportunities experienced when complying to the IVDR, from an industry perspective.

Leo Jacobs
Dr. Leo Jacobs – Registered Clinical Chemist at Meander Medical Centre (Department of Clinical Chemistry and Hematology)

Since 2015, Dr. Leo Jacobs has worked at the Meander Medical Centre in Amersfoort where he is responsible for the central diagnostic laboratory, IT and quality assurance. Between 2015 and 2021 he was also a board member of the Netherlands society for clinical chemistry and laboratory medicine (NVKC). In 2018 he founded the Dutch “Taskforce IVDR”.

At the Qarad IVDR Conference 2022, he will talk about the impact of the IVDR on laboratories including in-house developed devices.

*More information on our third guest speaker will follow later.


Register Here To Join The Qarad IVDR Conference 2022

Are you booking your tickets before August 31, 2022? Good news, you will get get a discount of €200!
Please use the promo code “EARLYBIRD” and enjoy your discount. Be sure to book in time, because the conference seats are limited.

If your company billing address is in Belgium, please select a “BE” ticket. If your company billing address is outside of Belgium, please select a “non BE” ticket