(e)CTD and Authoring at Genzyme Presentation for Medical Writer Groep Nederland 8 December 2005
What … � CTD and Documents � Tools � Authoring / Review and RA Operations � Some tips on Do’s and Don'ts
Diagrammatic Representation of the ICH Common Technical Document Not part of CTD but Module 1 part of eCTD Regional Admin Information 1.1 Submission T of C CTD Table of Contents 2.1 CTD Module 2 CTD Introduction 2.2 Nonclinical Clinical Overview Overview 2.1 2.5 Quality Overall Summary Nonclinical Written Clinical 2.3 and Summary Tabulated Summaries 2.7 2.2 Module 3 Module 4 Module 5 Quality Nonclinical Clinical 3 Study Reports Study Reports 3.1 T of C 4 5 4.1 T of C 5.1 T of C Source: http://www.ich.org/MediaServer.jser?@_ID=554&@_MODE=GLB
How deep down… Module 2 2.1 OVERALL CTD TABLE OF CONTENTS OF MODULES 2, 3, 4, AND 5 2.2 INTRODUCTION 2.3 QUALITY OVERALL SUMMARY 2.3.S DRUG SUBSTANCE 2.3.S.1 General Information 2.3.S.2 Manufacture 2.3.S.3 Characterization 2.3.S.4 Control of Drug Substance 2.3.S.5 Reference Standards or Materials 2.3.S.6 Container Closure System 2.3.S.7 Stability 2.3.P DRUG PRODUCT 2.3.P.1 Description and Composition of the Drug Product 2.3.P.2 Pharmaceutical Development 2.3.P.3 Manufacture 2.3.P.4 Control of Excipients 2.3.P.5 Control of Drug Product 2.3.P.6 Reference Standards or Materials 2.3.P.7 Container Closure System 2.3.P.8 Stability
eCTD � Consideration for granularity: � Expected change of the document versus the management of lots of documents. � Directory structure according to eCTD: m4 41-toc 42-stud-rep 421-pharmacol � Individual documents contain bookmarks, hyperlinks within the individual document and to other documents in the same submission sequence.
What … � CTD and Documents � Tools � Authoring / Review and RA Operations � Some tips on Do’s and Don'ts
Tools Shown are all instances where a file has been used .
Tools (continued) the Delta view of a submission (Life Cycle Management)
What … � CTD and Documents � Tools � Authoring / Review and RA Operations � Some tips on Do’s and Don'ts
Pre authoring/ Authoring/ Formatting Compile/Publish/ Archive Planning Review Print Overall Submission Admin Interface with Admin (provide templates and instructions) and their output supports our process Entire Entire Entire Submission Submission Submission CMC CMC Non Clinical Non Clinical Clinical Clinical - A component is available for - Commitment to Agency - Authors and Reviewers A section of Submission arrives Submission is complete formatting - Commitment to Organization are identified In RA Ops (with sign-off) and out the door - Product Team is assembled - Timelines are established QC Management and Tracking
Role of RA Operations and Authors RA Ops: � Provides support to authors and reviewers with respect to source summary document formatting, posting for review and version control in the official regulatory project area. Authors: � ‘Pre-publish’ tasks like: � Use of Templates, � Follow formatting guide, � (pre-) cross referencing in blue
Global Authoring/Review/Formatting Detail Slide #1 – Green Draft Document Leader(a) (author/contributor) RA Section Coordinator communicates content EU Primary requirements to, and compiles Reviewer content provided from authors collects comments, and contributors to produce the identifies and Green Draft – makes available addresses issues, to reviewers via Livelink. collates in a single document RA Section Coordinator collates comments and edits RAOps (US or EU) provided by primary Provides support to reviewers to produce an Green Draft v1 Section Coordinator updated Green Draft and working version Secondary with respect to both summary of issues for available in Reviewers working version and discussion/resolution at the Livelink Review source summary 1st Team Roundtable document US Primary formatting, posting Reviewer for review and collects comments, version control in identifies and the official addresses issues, regulatory project Green Draft v1 collates in a single area. source secured in document Green Draft v1.1 Livelink Project available in Livelink Review RAOps (US) for Roundtable Collects and prepares supportive documentation Secondary Discussion necessary for inclusion in submissions (i.e., Reviewers validation reports, qc documents, preclinical Green Draft v1.1 study reports, article reprints, etc) including as source secured in necessary, scanning, bookmarking and Livelink Project hyperlinking and qc components Roundtable Review discussion/resolution of comments and issues Ongoing pre-publishing work on source drafts identified in the Green Review cycle. Potential regarding formatting requirements to meet final need to request additional input/clarification from publishing needs (e and paper). Document Leaders continue at RA Section Coordinator - next page
Global Authoring/Review/Formatting Detail Slide #2 – Yellow Draft Document Leader(s) (author/contributor) RA Section Coordinator communicates content EU Primary requirements to, and compiles Reviewer content provided from authors collects comments, and contributors to produce the identifies and YellowDraft – makes available addresses issues, to reviewers via Livelink. collates in a single document RA Section Coordinator collates comments and edits RAOps (US or EU) provided by primary Provides support to reviewers to produce an Yellow Draft v1 Section Coordinator updated Yellow Draft and working version Secondary with respect to both summary of issues for available in Reviewers working version and discussion/resolution at the Livelink Review 2 nd Team Roundtable source summary document US Primary formatting, posting Reviewer for review and collects comments, version control in identifies and the official addresses issues, regulatory project Yellow Draft v1 collates in a single area. source secured in document Yellow Draft Livelink Project v1.1 available in Livelink Review RAOps (US) for Roundtable Collects and prepares supportive documentation Secondary Discussion necessary for inclusion in submissions (i.e., Reviewers validation reports, qc documents, preclinical Yellow Draft study reports, article reprints, etc) including as v1.1 source necessary, scanning, bookmarking and secured in hyperlinking and qc components Livelink Project Roundtable Review discussion/resolution of comments and issues Ongoing pre-publishing work on source drafts identified in the Yellow Review cycle regarding formatting requirements to meet final publishing needs (e and paper). continue at RA Section Coordinator - next page
Global Authoring/Review Detail Slide #3 – Red Draft Document Leader (s) (author/contributor) RA Section Coordinator communicates content EU Primary requirements to, and compiles Reviewer content provided from authors collects comments, and contributors to produce the identifies and Red Draft – makes available to addresses issues, reviewers via Livelink. collates in a single document RA Section Coordinator collates comments and edits RAOps (US or EU) provided by primary Provides support to reviewers to produce an Red Draft v1 Section Coordinator updated Red Draft and working version Secondary with respect to both summary of issues for available in Reviewers working version and discussion/resolution at the Livelink Review source summary 3rd Team Roundtable document US Primary formatting, posting Reviewer for review and collects comments, version control in identifies and the official addresses issues, regulatory project Red Draft v1 collates in a single area. source secured in document Red Draft v1.1 Livelink Project available in Livelink Review RAOps (US) for Roundtable Collects and prepares supportive documentation Secondary Discussion necessary for inclusion in submissions (i.e., Reviewers validation reports, qc documents, preclinical Red Draft v1.1 study reports, article reprints, etc) including as source secured in necessary, scanning, bookmarking and Livelink Project hyperlinking and qc components Roundtable Review finalization and Team sign-off of content – Ongoing pre-publishing work on source drafts released for pre-publishing and compilation of final regarding formatting requirements to meet final draft intended for senior management review and publishing needs (e and paper). sign-off continue at Module Coordinator - next page
What … � CTD and Documents � Tools � Authoring / Review and RA Operations � Some tips on Do’s and Don'ts
General tips In order to have a good quality PDF to include in an electronic submission or to print on paper: � Font: Times New Roman � Narrative body text 12 point � Headers and footers 10 point � Tables not smaller than 10 point. Use 12 or 11 if possible � No background shading (also not in tables)! � No other colors than black and blue (blue for hyperlinks only)
General tips (continued) Content � In each module acronyms and abbreviations should be defined the first time they are used. Linking: � Cross reference is done to the module, sub module and volume � Authors should already indicate the inter-document cross reference to be made, as precisely as possible, in the correct format. � The intra – document references should be made by the author (Caption for tables and Figures, cross references)
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