Le Italian Medicines Agency (AIFA) recently published news regarding a new document ‘Questions & Answers Version 1.0’. In order to facilitate the implementation of new Clinical Trial Regulations.
This document collects the Questions & Answers already published on the AIFA institutional website, grouping them by type, with updates and the addition of new Q&As. The document will be progressively updated by AIFA. The Questions & Answers are specific to Italy and relate to questions that are not already present in the documents published by the European Commission.
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