CRED Practical Document Writing and Management

Global Dossier

If RO Involved ● Clone ‘current’ documentation from latest approved application (M2-5) ● Team use a document tracker for version control and updates for RO ● Output sequence created of the global dossier and new sequences added for each ‘wave’ ● Further cloning now take place for countries accepting eCTD, or the output can be used to add regional information, TOCS (if required), ready for CTD or paper submissions Implemented by International RA ● International team create global dossier in shared area ● Document Tracker used for version control & updates made when required or at each wave

EVERY ORGANISATION CALL IT AND HANDLE IT IN DIFFERENT WAYS!!

Suggestions… • Global Dossiers work well if roll out is on a large scale. • If local affiliates submit on your behalf, always make sure the regional information comes back to you so the lifecycle can be viewed at any time • For CTD, use sequence numbers internally to easily keep track of activities along the way. • Re-use of documents can save time, so consider this when writing.