Ground Rules for Writing, Formatting and Updating Content
Introduction to eCTD
CMC Information Presentation
Summaries in an NDA
Putting the Whole Submission Together
Bulk Data from Non-Clinical and Clinical Studies
Introduction to the FDA’s ESG
Who should Attend
Regulatory Affairs
Quality Assurance
Pharmacovigilance
Project Management
Regulatory Operations
Medical and Technical writers
Professionals preparing IND, DMFs, NDAs and other submissions
IT Professionals
Anyone responsible for providing content for the CTD
Past Events
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada - 14-15 Nov 2019, DoubleTree by Hilton Hotel San Francisco Airport, Burlingame, California, United States (68173)
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada 2017 - 20-21 Sep 2017, Sydney, Australia (68645)
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada 2017 - 29-30 Aug 2017, Zurich, Switzerland (69882)
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada 2017 - 03-04 Aug 2017, Singapore (68644)
eCTD Submissions of IND and NDA/BLA to the US FDA:2016 - 18-19 Aug 2016, San Diego, California, United States (59975)
eCTD Submissions of IND and NDA/BLA to the US FDA 2016 - 12-13 May 2016, San Diego, California, United States (53630)
Important
Please, check "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" official website for possible changes, before making any traveling arrangements
