Webinar: INDs and the eCTD Submission Mandate

Event Date: September 12, 2018, 12:00-1:00pm ET

Registration Deadline: September 11, 2018

Speaker:

• Jim Nichols, Chief Operations Officer, Cunesoft Inc.

Pricing with Contact Hours

Member: $15 | Nonmember: $75

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This course is approved for 1.0 ACRP contact hours. Accreditation Details

Pricing Without Contact Hours

Member: $0 | Nonmember: N/A

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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.

Upon completion of this Webinar, attendees should be able to:

1. Understand the FDA mandate for submissions in eCTD format
2. Comprehend the basics of CTD and eCTD
3. Understand key terms, terminology and requirements for eCTD
4. Initiate processes to comply with the eCTD mandate