Description: Clock stops are often seen as a challenging time for applicants seeking EMA marketing authorisation. In many cases, time may not seem to be on the applicant’s side. However, this is a prime opportunity to seek thoughtful input from external experts that can help anticipate underlying procedural and scientific concerns linked to the Day 120 List of Questions (LoQs). Answers to these LoQs should also address underlying Major Objections (MOs) so those can be pre-emptively resolved or diminished. In fact, a well-executed clock stop may help the applicant more thoroughly address key underlying scientific and regulatory issues when preparing their responses—and ultimately resolve concerns that have or might lead to Day 180 MOs. This session will explore what to consider when requesting a clock stop, when to seek external input, and why time is on the applicant’s side in a well-executed clock stop prior to the restart on Day 121.
Learning Objectives:
Understand the value in seeking external expert input during Day 120 clock stop.
See how appropriately addressing questions and preparing responses at Day 121 may help anticipate and pre-emptively resolve Major Objections.
