№ lp_1_2_45079
This document provides answers to frequently asked questions regarding the raw data proof-of-concept pilot for clinical study submissions to EMA.
Year: 2022
Region / city: European Union
Subject: Regulatory procedures, Clinical studies data
Document type: Questions and Answers
Organization: European Medicines Agency (EMA)
Author: European Medicines Agency
Target audience: Industry professionals, regulatory bodies
Period of validity: 2022–2024 (pilot phase duration)
Approval date: September 2022
Amendments date: None
Price: 8 / 10 USD
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