Key Regulatory Topics: eCTD
Table of Contents
- ICH E2B Expert Working Group Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs)E2B(R3) Data Elements and Message Specification
- ICH M2 EWG Electronic Common Technical Document Specification
- ICH M8 Expert Working Group 16 17 18 19 20 21 22 ICH Electronic Common Technical Document (eCTD) v4.0 23DRAFT ICH Implementation Guide v1.0 24
- Guidance for Industry Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Draft Guidance)
- CMDh Best Practice Guide on the Use of the Electronic Common Technical Document (eCTD) in the Mutual Recognition and Decentralised Procedures Doc. Ref.: CMDh/084/2008/Rev3 November 2011
- Practical Guidance For the Paper Submission of Regulatory Information in Support of a Marketing Authorisation Application When Using an eCTD or NeeS as the Source Submission (v2.0 March 2010)
- Guidance for Industry—Submitting Marketing Applications According to the ICH-CTD Format—General Considerations (Draft Guidance)
About the Book
Available formats: print and e-book
The process of compiling your electronic Common Technical Document (eCTD) can be overwhelming, but—with RAPS’ on your side—you know that you’ll have a competitive advantage.
Featuring guidance documents from the International Conference on Harmonization, European Medicines Agency and the US Food and Drug Administration, Key Regulatory Topics: eCTD keeps you on the cutting edge of regulatory.
Who will benefit from this book?
Newcomers and experienced regulatory professionals will find value in the eCTD guide. It provides a solid background in the basics of compiling your eCTD while also containing a wealth of information for experienced pros seeking answers to specialized questions.
Purchasing Options
This book can be purchased in the following formats:
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
- Printed book.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
Published by RAPS © 2013 Paperback. 632 pages.
