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

Description

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

Future Events

eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada 2020

Important

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

Prices are for evaluation only.

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