May 2022: CTIS Update

European Medicines Agency updated about the upcoming event, Clinical Trials Information System (CTIS) bitesize talk: Modifications over the What’s New Section on May 25, 2022:

The update provides the presentation for the bitesize functionality talk that will be held on May 31, 2022. The presentation explains the allowed submissions during the ongoing evaluation of a clinical trial application. The substantial and non-substantial modifications for the form, Member State Concerned (MSC) and Part I and II of the CTA are also listed. It also provides an overview of the timeline required to validate and submit decisions.

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