ATMP Development

Date

Tuesday, February 28th 2023 (09:30 - 18:30)

Location

Galileilaan 15, 2845 Niel, België

Language

English

Organised by

Sillar Clinical

Categories

Tags

Insights into the Belgian framework of CTR / CTIS

As of 31 January 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.

As we approach this key date, at.las and Sillar Clinical are organizing an event for ATMP developers at which practical insights into the Belgian framework of CTR as well as implementation and practical use of CTIS will be discussed.  

This event will be particularly of interest for companies developing ATMP and will be of interest for both academic institutions and commercial companies that want to learn more 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.  Want to learn more about the EMA structure and CTR?  We already look forward to welcome you at the event on 28 February 2023!

Programme

  • 09h30 - 10h00  -  Welcome

  • 10h00 - 10h30  -  Regulatory Framework : working groups EMA & STA

  • 10h30 - 11h30  -  ATMP focus : classification and guidelines

  • 11h30 - 12h00  -  Q&A

  • 12h00 - 13h00  -  Lunch

  • 13h00 - 14h00  -  CTR and its implementation in Belgium

  • 14h00 - 14h30  -  Q&A

  • 14h30 - 15h00  -  Break

  • 15h00 - 16h00  -  Submission through CTIS

  • 16h00 - 16h30  -  Q&A

  • 16h30 - 16h45  -  The FAMHP perspective

  • 16h45 - 17h30  -  Panel discussion

  • 17h30 - 18h30  -  Networking drink