eCTD Submissions of IND and NDA/BLA to the US FDA 2016 is a course that covers topics such as:
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
eCTD Submissions of IND and NDA/BLA to the US FDA 2016 brings together:
Medical and Technical writers
Regulatory affairs professionals preparing IND, DMFs, NDAs and other submissions
Supervisors, and lead workers in Regulatory Affairs
Project Managers, Directors
IT professionals looking to make eCTD submissions
Quality Assurance and Quality Control
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
