Advanced eCTD and the Educated Sponsor

This week’s blog posting is from Rahul Mistry, CEO of GlobalSubmit, who recently was a featured speaker at the RAPS workshop entitled “Advance eCTD Submissions”.  Rahul’s presentation focused on eCTD quality, a topic that obviously interested the audience based on the significant number of questions that he received.    

Two weeks ago I had the pleasure at presenting at an Advanced eCTD Workshop hosted by RAPS in Rockville, MD. During the course of three days, I had the pleasure of speaking and listening with a number of people from different companies. Here is what I learned:

  • While the workshop provided for an international perspective on eCTD, most attendees wanted to focus on the US. It became apparent that the primary strategy of many companies is to produce all US submissions in electronic format, and handle other regions as a secondary goal, if at all.
  • There continues to be confusion on regulatory activities, and, specifically how to correctly use the related sequence tag in the regional XML file. Please see the article “Secrets of eCTD Related Sequences” for details.
  • The FDAs infrastructure and current practices are of particular interest. During my presentation I was able to address a number of questions including the FDAs severity levels, and what the consequences are of errors in a sponsor’s submission.
  • Most people are not aware of the advantages of using fillable forms for the FDA which is the ability to automate the integration of a submission with other systems that exist at the FDA, such as submission tracking.
  • There was great interest on RPS and how it will impact the day-to-day lives of a publisher. The reality is that there will be very little that changes for sponsors – the big changes are for the vendors who need to update their software, and even of then, the change is minimal. A fair analogy would be saving a Microsoft Word document as Word Perfect or PDF file. The author using Microsoft Word need not know how Word Perfect saves its files; rather it is Microsoft’s responsibility that they save the document correctly.

Article written by

I am GlobalSubmit’s director of professional services. My area of expertise is electronic document management and regulatory submissions, specifically eCTD. I have 12 years of biopharmaceutical industry experience in the US, Europe, Israel and Japan, concentrating on content management for Regulatory Affairs & Submissions, Clinical Development, and Manufacturing, and in submission assembly and publishing. I have worked with over 50 pharmaceutical clients. Previously, I was the practice lead for the Subject Matter Experts/Business Analysts group at First Consulting Group (FCG), now part of CSC. I supervised a group of 12 SMEs/BAs. I was instrumental in the development of the FirstDoc® suite. I developed the project delivery methodology for FirstDoc® R&D, including training materials, project plans, workshop methodology and materials, and requirements and design specifications. I managed the design and development of FirstDoc® GMP and FirstDoc® Legal. Please feel free to contact me at kathleen.clark@globalsubmit.com if you are interested in talking about eCTD products or consulting services, or if you have ideas for the blog.

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  1. Health Canada Increases Acceptance of eCTD Submissions | Ask Cato

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