This program will introduce attendees to the FDA mandate for all submissions (including commercial INDs) to be provided in the eCTD (electronic Common Technical Document) format. It will review the mandate, terms, terminology, key concepts and steps to enabling the FDA electronic submissions gateway.
Understand the FDA mandate for submissions in eCTD format.
Comprehend the basics of CTD and eCTD.
Understand key terms, terminology and requirements for eCTD.
Initiate processes to comply with the eCTD mandate.