Example: marketing
Eu module 1 ectd
Found 2 free book(s)
EU Module 1 eCTD Specification - Europa
esubmission.ema.europa.euEU Module 1: Regional Information The ICH Common Technical Document (“CTD”) specifies that Module 1 should contain regionspec- ific administrative and product information. The content and numbering of Module 1 for the EU is specified in the latest version of …
eCTD Guidance Document - Europa
esubmission.ema.europa.euThe structure and organisation of an eCTD submission is defined by the following standards: • ICH M2 eCTD Specification • EU Module 1 Specification • Relevant ICH and EU Q&A docs . Annex 1 contains links to the currently approved version of these documents.