eCTD Requirements Under PDUFA V INDs, NDAs, BLAs in eCTD Format Will Be Required

Held Nov. 16, 2011

FDA's refusal to accept your submission and its underlying datasets can bring years of R&D, clinical and regulatory work to a grinding halt — costing you hundreds of millions of dollars in lost profits and millions more in expenses to rework.

Add the upcoming PDUFA V reauthorization which is expected to mandate eCTD format for all new chemical/biological entity submission types to CDER and CBER — this includes INDs, NDAs and BLAs — and you have the “perfect storm” for submissions specialists.

This will especially hit hard small and mid-sized companies who only do INDs, as well as investigators in academic settings.

While PDUFA V is 13 months away, and a transition period is provided, a conservative timeline dictates that you need to start now -- remember, your validated processes and systems must go live 6 to 12 months prior to any FDA deadline.

This webinar will give you the tools, intel and strategy to start today and be prepared to purchase, implement, validate and go live with fully functioning, compliant systems.

So, mark your calendar on Wednesday, Nov. 16. for the FDAnews webinar eCTD Requirements Under PDUFA V. You’ll hear a leading regulatory-submissions consultant deconstruct PDUFA V and spell out the steps you need to take now.

Antoinette Azevedo has spent her career guiding FDA-regulated manufacturers on strategies for document management and electronic publishing. You’ll gain a step-by-step understanding of how to prepare multiple types of submissions in eCTD format ... while taking only 90 minutes out of your busy schedule.

Here are just a few of the topics Ms. Azevedo will cover:

  • How an IND maps to the eCTD table of contents
  • Benefits to sponsors of submitting INDs electronically when transitioning to submitting marketing applications (NDAs and BLAs)
  • The folder structure, document content format, and navigation backbone standards
  • Preparing compliant source documents and datasets for eCTD submissions
  • FDA perspective on INDs in eCTD format
  • And much more

Like every FDAnews webinar, eCTD Requirements Under PDUFA is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your home office.

Of course, Ms. Azevedo will be on hand to answer all of your questions. Simply submit your questions via email, and you’ll have answers by the time the session ends.
Everyone in your organization with a role in eCTD deserves to take part in this event — and they can do so at a cost that won’t break the budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.

The learning curve is steep, the budgets large. Don’t take a risk — sign up for this timely learning session now.

Spread the word throughout your organization. Make particularly sure to notify the following key staff:

  • Compliance officers
  • Consultants/service providers/regulatory operations
  • Data management and statistics personnel
  • Engineering and design control teams
  • Executive management
  • Managers
  • R&D staff
  • Regulatory/legislative affairs professionals
  • Strategic planning and business development staff
  • Dossier managers
  • IT personnel who support regulatory staff
  • Clinical affairs personnel
  • Medical writers
  • Documentation/report services staff
  • Clinical project specialists
  • Clinical research associates
  • Study research coordinators
  • Study sponsors
  • Training personnel

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Antoinette Azevedo, principal,, advises pharmaceutical and biotech companies on the use of technology to manage regulatory documents and publish electronic submissions. serves a client mix ranging from international pharma giants to small virtual biotech companies. Previously, Ms. Azevedo directed West Coast operations for Liquent, and was in charge of regulatory submission publishing for the CSC Consulting life sciences practice.

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