Filing DMFs in eCTD Format

Wednesday, September 14, 2016 - 11:00am to 1:00pm
Thursday, September 15, 2016 - 11:00am to 1:00pm

FDA has published final guidance that mandates a May 2017 deadline for all NDAs/BLAs/ANDAs/DMFs to be submitted in eCTD format.  Exemptions from the mandate and deadline will not be granted commercial sponsors.  In the meantime, the only electronic submission format accepted by FDA is eCTD and FDA is requiring eCTD in special cases ahead of the deadline.

Every regulatory professional should know the standards, groundwork, expertise and technology required to submit compliant eCTD submissions to FDA.

What Makes this Training Unique

  • A trainer/consultant with years of real-world experience in filing DMFs/ASMFs in eCTD and non-eCTD electronic formats
  • Review of the eCTD requirements of FDA, Health Canada, and EU
  • Technical training on the use of MS Word and Adobe Acrobat to create files for eCTD submissions
  • How to check for compliance of PDF files
  • How to compile and verify compliance of eCTD submissions

Put yourself and your company a step ahead of competitors by mastering the technical skills needed to meet the impending electronic submission mandates. Several similar programs have sold out, so register today!

Learning Objectives

At the conclusion of this series, participants should be able to:

  • List fundamental strategies for preparing eCTD submissions
  • Explain the technical requirements of eCTD submissions
  • Demonstrate best practices in the use of MS Word and Adobe Acrobat in preparing content for eCTD submissions
  • Decide and justify whether in-house publishing or outsourcing is the solution for submitting a US eCTD that is compliant with CDER and CBER requirements

Presenter(s)

Antoinette Azevedo

President & CEO
e-SubmissionsSolutions.com

Antoinette Azevedo founded e-SubmissionsSolutions.com to advise biotechnology and pharmaceutical companies on the use of technology to manage regulatory and controlled documents and publish electronic submissions and registrations. Azevedo’s clients range from large, international pharmaceutical companies to small, virtual biotechnology companies. Previously, Azevedo was director of west coast operations for Liquent and principal consultant in CSC Consulting’s life sciences practice. Azevedo’s experience ranges from developing strategies for document management and electronic publishing, implementing fully validated systems, to staff augmentation and eCTD publishing services resulting in submissions accepted by regulatory authorities worldwide.

Cancellation Policy

Note: No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you are unable to attend the webinar, a recording of the webinar will be provided to all registered persons.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3450 or email ipecamer@ipecamericas.org