One of our most praised presentations, this Webinar by renowned eCTD expert Antoinette Azevedo will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review. So you can avoid a costly Refuse-to-File (RTF) by FDA.

Negotiations are underway between FDA and industry on PDUFA V reauthorization. These negotiations will result in legislation submitted to Congress in January 2012. PDUFA must be reauthorized by October 1, 2012 to enable CDER and CBER to collect user fees and perform review of INDs, DMFs, NDAs, ANDAs and BLAs. PDUFA V is expected to mandate eCTD format for all submissions to CDER and CBER except for single-patient compassionate-use INDs.

It is expected there will be a transition period from Oct. 1, 2012 to 2015 for certain submission types, but likely NDAs and BLAs will be required immediately, with a transition for DMFs and INDs.

It is also expected that CDISC standards for electronic datasets will be mandated. This presentation will provide more details about this important eCTD mandate from Congress.

6 Things You will Learn:

  • Top issues regulatory authorities have with eCTD and how to avoid them.
  • Preparing submission-ready source documents and datasets for submission in eCTD.
  • Whether to purchase an eCTD publishing system or to outsource.
  • The role of an electronic document management system (EDMS) in an eCTD publishing solution?
  • How to prepare for the technical challenges of eCTD.
  • How to interact with regulatory authorities to assure your eCTD submission is accepted for review.

Attendees will receive these free gifts:

  • Subscription to FDA Digest – 483/warning letter e-newsletter
  • Six-month subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
  • Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
  • “Lean Compliance for Midsized Companies” (from Journal of GXP Compliance, January 2008)

About the Presenter:

Antoinette Azevedo founded (a California corporation) to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions.

Ms. Azevedo’s clients range from large, international pharmaceutical companies to small, virtual biotechnology companies — all attempting to be better prepared to manage controlled documents and produce electronic INDs and drug/biologic registrations.