EU Harmonised Technical eCTD Guidance Updated

A number of changes have been implemented in the updated guidance document and some of these changes will only apply after 1st of July 2016 once the updated EU Module 1 specification enters into force, for example section 3.2.2. A number of updated recommendations can be applied as of now, for example chapter 4. “Click Here”:http://goo.gl/XgKpGf