CRED Practical Document Writing and Management

Dealing with historical documents

NeeS to eCTD in practice: - ● For baselines submissions, navigation does not need to be reset, as will not be re- checked by agencies. However: - – Documents / Reports may already contain ToCs & Bookmarks and leave these in – Historical internal cross-references can also be left in, but hyperlinks will be broken, so would appear as a validation issue. RO can change blue text back to black easily and remove broken links (with the use of an adobe plug in tool). ● All Portable Document Format (PDF) and Module TOCs currently used in NeeS will no longer be required (2.1, 3.1 & 4.1 and 5.1). ● A tracking table should be used to track the lifecycle (a separate leaf under M1.0). ● More information can be found here: - http://www.hma.eu/277.html and http://esubmission.ema.europa.eu/tiges/docs/eCTD%20Guidance%20v4%200- 20160422-final.pdf