Instructions for presenters in the short topic session

Published

September 14, 2024

What aspects have made submissions to the short topic session successful in the past?

  • Ask one or more clear questions to panel of regulators.
  • Ask questions that allow for a discussion, which do not invite a yes/no answer or an obvious answer from a regulator.
  • Do your homework!
    • Have similar questions been dealt with in other related areas, e.g. another therapeutic area or another quantitative field?
    • Have regulators commented on this in other instances?
    • etc.
  • Reference to actual regulatory interactions, e.g. with regional differences.
  • Do not ask for recipes along the lines: If we as sponsor do X will regulators then for sure agree to it?
  • Before submission of a topic ask yourself: What can a regulator meaningfully answer to my questions?

Format of the short topic session

To guarantee the success of the session we would like to re-iterate the format:

  • We have six topics distributed over two hours, which leaves each topic with 20min total time.
  • You can present for five minutes using maximum two slides.
  • Presentation must be in person. There will be no virtual presentations in this session.
  • Please make sure your presentation of the issue is generic enough so that everyone in the room can follow.
  • Please ask one or more very explicit questions to the panel of regulators.
  • Do not ask regulators for “recipes” in the sense of “if we do that then you guarantee to do that”.
  • When formulating your questions ask yourself: “What would I answer if I were a regulator?” This may help to be precise and specific.

Deadline

Please send us your slides until Friday, 6th September.

Questions?

For feedback and questions send an email to info@efspiworkshop.org.