Questions and Answers about the Raw Data Proof-of- Concept Pilot for Industry

8 March 2023 – the EMA published Q&A guidance on the scope, terms of participation and data submission process for the proof-of-concept pilot.

This document provides Answers to commonly asked Questions about the proof-of-concept (PoC) pilot on the submission and analysis of ‘raw data’ from clinical studies as part of selected initial marketing authorization applications (iMAAs) and post-authorization applications submitted to the EMA.

Q&A 2022 Annual Report 
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /