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Updates:[January 2024]: Lecture 14 - CTIS Training material catalogue updated with latest information[March 2023]: Training document material from EMA updated and lecture 14 updated accordingly; New Q & A document from the CTIS/CTR query management working group attached (lecture 15)--On 31st January 2023, the Clinical Trial Regulation (CTR) 536/2014 came into force in the European Union (EU) and repealed the Clinical Trials Directive 2001/20/EC. With this Regulation, the EU harmonises the proce

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