Dr. Luc Van Hove from MARACA International chairs three IVD sessions at the RAPS 2020 Euro Convergence meeting. This is the annual European convergence of regulatory professionals, which was scheduled in Brussels this year, but due to Corona, is converted to a full virtual meeting. Being part of the organizing scientific committee, Luc says “I’m excited about the scientific content of this meeting, you will enjoy it”. “It was a unique experience to move the presentations to this virtual environment”.
Luc is chairing “Regulatory hurdles to overcome to introduce nanotechnology-based IVDs and medical devices to the European Market, a Safe-N-MedTech concern”, 27 Oct. at 9:45-10:15 CET. This sessions reviews the regulatory issues and possible solutions to bring nanotechnology-based devices to the European market. The Safenmt consortium will discuss with the audience how to best support such devices to the market using two test cases and Luc will introduce the audience to the hurdles and possible regulatory roadmap for such nanotechnology-based devices.
The next session which is chaired is called “Implementing practices to comply with the IVDR”, 27 Oct. at 13:30-14:30 CET. Dr. Armin Ritzhaupt from the European Medicines Agency (EMA) will present the European Commission’s view on how to implement the new IVDR.
Hearing it directly from the EMA and from industry will stimulate an interesting discussion with the audience.
The last session is “What is sufficient clinical evidence for IVDs in preparation for the IVDR?”, 28 Oct. at 13:30-14:30 CET. Dr. Julien Senac from TUV SUD will represent the Notified Body view and Luc will present the industry perspective. This is a hot topic, which will create a lot of interest and discussion.
After the session presentations there will be a Zoom chat room available to meet the speakers and discuss your personal questions. This will give you the real congress experience.
During the congress there will be also other chat room opportunities to exchange ideas and interact with RAPS members.
As you can see this will be a great meeting to participate in for regulatory professionals.
See you at the 2020 RAPS Euro Convergence.