Event: Insights into the Belgian framework around CTR / CTIS

Sillar and at.las invite you to join us at the Science Park in Niel for an interactive seminar on February 28th focused on the Belgian framework of CTR, as well the implementation and practical use of CTIS.   

As of January 31st 2023, sponsors must submit all initial clinical trial applications under the Clinical Trial Regulation (CTR – (EU) No 536/2014) using the EU portal (Clinical Trials Information System – CTIS) and can no longer submit via the processes outlined in the Clinical Trials Directive.

Both academics and commercial developers are welcome to join us and learn about the ins and outs of submitting a clinical trial application under CTR.  

This event is supported by FAMHP who will be presenting and participating in the panel discussion.

Will be discussed:

  • Regulatory Framework : working groups EMA & STA
  • ATMP focus : classification and guidelines
  • CTR and its implementation in Belgium
  • Submission through CTIS
  • The FAMHP perspective

Vanessa Parrein (Sillar), Michael Canning (NCD consultants), Christophe Lahorte (FAMHP) and Nele Steens (FAHMP) will be sharing insights and experiences. The panel discussion will be moderated by prof. dr. Joeri Aerts (VUB).   

Practical information:

•    Date: Tuesday February 28th 2023 
•    Time: 09.30 h – 18.30 h
•    Location: Science Park, Galileilaan 15, 2845 Niel. 

•    Participation is free of charge for at.las members

There will be opportunity to ask questions during the Q&A’s, as well as over lunch and during the network reception

How to register?

at.las members can join for free

Find the entire program and registration form here.