eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada

  • 5-6 August 2019
  • Courtyard by Marriott Newark Liberty International Airport, NJ, United States

eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada 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, EU and Canada brings together:

  • 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

eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada will be held in Newark, NJ, United States on 5-6 August 2019.

Venue

Courtyard by Marriott Newark Liberty International Airport
600 Routes 1 and 9 South,
Newark,
New Jersey,
United States
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Booking.com
1499-1699 US Dollar
No exhibition
ComplianceOnline
Rentalcars Savings

Past and Future Events

  • eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada - 5-6 Aug 2019, Newark, 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 - 3-4 Aug 2017, Singapore (68644)
  • eCTD Submissions of IND and NDA/BLA to the US FDA:2016 - 18-19 Aug 2016, San Diego, United States (59975)
  • eCTD Submissions of IND and NDA/BLA to the US FDA 2016 - 12-13 May 2016, San Diego, United States (53630)

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.