Events for Food and Drug Administration (FDA)

Navigating the FDA's New Requirements for eCTD Submissions

Sign up and learn about:
# Discover the top 10 reasons sponsors receive a refuse-to-file from the FDA on their eCTD submissions
# Gain clarity on the acronyms and jargon of eCTD and electronic submissions
# Effectively budget and develop project plans for eCTD submissions
# Understand why and how to start producing eCTD submissions at the IND phase
# Master the documentation requirements for electronic datasets for stability, nonclinical and clinical, and better communicate these requirements to colleagues early in the drug development cycle
# Assure the output of your in-house system is valid for FDA review

View the Event

Share or bookmarklet this web page at: