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Resource Library

EMA Regulation (EU) 536/2014 Resource List

DescriptionSourceLinkHelpful For…
Sponsor HandbookEMALinkGetting started and familiarizing with CTIS requirements
CTIS Training Dates, Registration & Content OverviewEMA / DIAEMA link and DIA Link Getting hands-on CTIS
High level overview of CTIS functionalityYoutubeLinkPreparing for training and gap analysis / process mapping
User personas - CTISEMALinkPlanning your team’s roles and responsibilities
Disclosure deferral rulesEMALinkUnderstanding the principles of disclosure of documents in CTIS
“Highlights” - CTISEMALinkKeeping track of on going updates and milestones, lessons learned

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