CRED Practical Document Writing and Management

Learning Outcomes; Recap

 Where we are now and how to deal with old, historical, non-CTD, paper dossiers – Encourage your RA teams to move towards eCTD whenever and wherever possible. eCTD is the future!  Dossier Management - how it’s recorded, maintained and archived; ● Paper ● Electronic (compatibility, size, software)  Hyperlinking – Think like an assessor!  CTD granularity – Consider the future of the lifecycle. Will your approach now, still work in the future?  Change Management – Always keep RO and submission group up to date with any version changes  ‘Global’ dossiers – Decrease time of global roll-out & reduce workload  Avoiding drift – Keep to the content lock date or risk jeopardising the submission