Become more confident in your daily practices by gaining a deeper understanding of the US and European regulatory requirements for Module 3 (CTD) of your application.

This course will cover the following topics: Agenda: Programme Day One What is the CTD? The road map to Module 3 Understanding ICH Assessing the impact of the harmonisation - ICH guidelines The ...

This course will cover the following topics: Agenda: Day 1 Schedule What is the CTD? The road map to Module 3 Understanding ICH Preparing the drug substance section of the application - US and EU ...

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (COM)" conference to their offering. The ...

While Health Canada's June announcement does not indicate the full transition of eCTD applications-Module 1 of the CTD will not be accepted in electronic form until Fall 2012, for instance-it is ...