Avoid the CDRH eCopy Confusion – How to Prepare a Compliant eCopy Submission| Archived Recording|Azevedo

Avoid the CDRH eCopy Confusion – How to Prepare a Compliant eCopy Submission| Archived Recording|Azevedo

March 11th, 2013 // 3:41 pm @


CD or Download Recording Available!

FDA eCopy Webinar Overview

eCopy is a new electronic submission requirement for most drug applications that has been in effect since the beginning of 2013. Our April 10 Webinar on eCopy was very well received, and addressed many of the confusing and contradictory aspects of eCopy.

There have been many reports of eCopy holds because of compliance issues with the eCopy format.  The issues can be any of the following:

  • File size
  • Stringent PDF file requirements
  • Folder structure
  • Folder naming conventions
  • File naming conventions
  • eCopy being radically different than the mandatory paper copy still required.

What You Will Learn in This FDA eCopy Webinar

  • What is the eCopy mandate that became effective 1 January 2013
  • What types of organizations are subject to the mandate?
  • What types of submissions are subject to the mandate?
  • How to avoid the factors that cause an eCopy submission to fail to load?
  •  What technical aspects of an eCopy submission trigger an eCopy hold?
  • What are the skills needed to prepare a compliant eCopy submission to CDRH?
  • Can FDA’s eSubmitter software be used to prepare a eCopy submissions?
  • Are there other choices besides FDA eSubmitter to prepare an eCopy submission?

Free With This eCopy Webinar

  • Recording of Webinar – Download or CD
  • eCopy MS Word CDHR Protocol Template. This offer includes user documentation and self-paced training – $3000 value. Also includes toolbars, installation guide and Acrobat job options.
  • Powerpoint slides to share with colleagues

According to electronic submissions expert Antoinette Azevedo, eCopy is much more technically challenging than CDRH is willing to admit. There are many eCopy guidance contradictions that are not clear and are not being clarified. This Webinar will help to make your eCopy submission process much more understandable. Note that eCopy submissions that do not meet standards will NOT be accepted by the FDA loading system.

Background – What Is eCopy?

CDRH has been requiring eCopy for every submission since January 1, 2013. eCopy is an exact duplicate of your paper drug submission.

The only exceptions are for data that is not practical to provide in  paper, such as raw data, statistical analysis, videos and x-rays. All required information must be submitted electronically for review on CD, DVD or Flash drive.

Submission types required for eCopy include:

  • IDEs
  • 510(k)s
  • Evaluation of all automatic class II designation petitions
  • PMAs – all submission types
  • Modular PMAs
  • PDPs
  • HDEs
  • HUDs, EUAs
  • Some INDs, such as devices used for screening blood
  • Pre-submissions
  • Some BLAs

eCopy Problems

In addition to these previously mentioned issues, FDA makes available free software for compiling an eCopy – eSubmitter.  While there are good points to using this software, there are also issues with the software that people should be aware of before getting started on eCopy.

It is possible to prepare a compliant eCopy without this software but people should be aware of the challenges.  Since PDF file format is the bulk of the content submitted in eCopy, PDF formatting competence is a critical requirement and most people in device regulatory affairs just do not have these skills.

Note that all technical support for eSubmitter is through email. It can take you several days via email to get most of your questions answered about  contradictory requirements in the CDRH final guidance for eCopy.

If your eCopy submission is rejected:

  • Submission is placed on hold
  • CDRH notifies you in writing for reasons for the hold and logistics to submit a replacement
  • If not updated in 180 days, your submission will be considered withdrawn
  • Review does not start until your valid eCopy is received and the user fee paid.

This new Webinar on eCopy will guide you through some of the complex challenges of filing your eCopy submission.

It also will provide you with guidance on how to use the free FDA eSubmitter software.

About Your Speaker

Antoinette Azevedo founded e-SubmissionsSolutions.com (a California corporation) in 2000 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/CTAs and drug/biologic registrations.

Ms. Azevedo is the author of  <SGML> Competitors & Markets, Products & Applications, 1994-1998, Antoinette Azevedo and David Henry Goodstein with M. Elizabeth Hunter, European Supplement by Hans Andriese, 1994, InterConsult, Inc. Arlington, MA.  Ms. Azevedo has lectured internationally for RAPS, DIA, FDANews, ExpertBriefings, and the Center for Professional Innovation & Education, at vendor user conferences, and for local regulatory affairs professional groups.  Ms. Azevedo has been a working member of the Drug Information Association EDM Reference Model Working Group since its inception in February 2008.

Ms. Azevedo was director of West Coast Operations for Liquent from 1997 to 2000. Ms. Azevedo was principal consultant in the CSC Consulting life sciences practice as technical lead for regulatory submission publishing from 1994 to 1997, working with pharmaceutical clients in North American and Western Europe. Her entire career has been devoted to document management and electronic publishing through a several generations of technologies and architectures, in various industries.   She dedicated her focus to life sciences beginning in 1994. She is experienced with a number of document management systems, publishing systems and toolsets, and a wide array of options for successfully producing electronic submissions.  Her experience ranges from developing strategies for document management and electronic publishing, to implementation of fully-validated systems, and production of paper and electronic submissions accepted for review by regulatory authorities worldwide.





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