FAQs: How to Create, Submit and Withdraw a Clinical Trial Application — CTIS Training Program - Module 10

On 23 September 2022 the EMA published version 1.3 of the updated FAQs guidance on how to create, submit and withdraw a clinical trial application.

This FAQs provide answers to questions regarding the creation and submission of Initial CTAs, the creation and submission of Substantial modifications CTAs, the creation and submission of Additional MSC CTAs and non-substantial modifications.

Read the pdf 
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /