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Monday, 11/10/2025 3:37:00 PM

Monday, November 10, 2025 3:37:00 PM

Post# of 517474
How to prepare for an EMA oral session... Hmmm
disclaimer: was thinking of calls early this morn, had to travel
saw the slide and now pausing cause to me, an EMA oral session
means some serious questions are going to be asked.

https://resource.ddregpharma.com/blogs/how-to-prepare-for-oral-explanations-with-ema/

An oral explanation is a presentation and question-and-answer session in person between representatives of an applicant and a European Medicines Agency committee. It forms an important part of the step-by-step evaluation for the medicines that are intended for EMA approval. It tends to be organized when the CHMP still has significant objections regarding the application; the applicant must provide clarifications on the committee’s issues.
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