CRED Practical Document Writing and Management

Learning Outcomes; Recap

 What happens to the documents between leaving our desks and arriving on the reviewer’s desk? RO: Co-ordinate, plan and resource publishing activities; format, publish, validate & submit, archive. Two step validation process at agency  Why styles and technical requirements are important – All of them!  What the Reviewer sees (has everyone seen an eCTD in practice?) - Agency and industry view  How to handle images, do we need them and are they readable? If you can edit the figure, then copy & paste as an image, and follow dpi guidelines