CRED Practical Document Writing and Management

Useful Links

ICH – eCTD Specification v3.2.2 http://estri.ich.org/eCTD/eCTD_Specification_v3_2_2.pdf EU Module 1 eCTD Specification http://esubmission.ema.europa.eu/eumodule1/index.htm Harmonised Technical Guidance for eCTD Submissions in the EU v4.0 http://esubmission.ema.europa.eu/tiges/docs/eCTD%20Guidance%20v4%200- 20160422-final.pdf Granularity Annex of the M4 Organisation Document for guidance http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R4_Organisati on/M4_R4__Granularity_Document.pdf ICH – CTD Organisation http://www.ich.org/products/ctd.html Volume 2 - Notice to Applicants https://ec.europa.eu/health/documents/eudralex/vol-2_en

EU CTD Q&As http://ec.europa.eu/health/files/eudralex/vol-2/b/ctd-qa-updatev3_2008-02_en.pdf

TIGes – Best Archiving Practice Specification http://esubmission.ema.europa.eu/tiges/BAP/BAP_Appendix_v1%200_June%202013.pdf

EU eCTD Validation Criteria v6.1 http://esubmission.ema.europa.eu/tiges/docs/eCTD%20EU%20Validation%20Criteria%20v6%201_March%2 02016-Final.xlsx