New eCTD Resources and RPS Educational Series

GlobalSubmit (the company I work for) has recently enhanced its web site to include a considerable amount of eCTD and RPS-related reference material.  Check out our Best Practice pages  for practical information on a variety of topics, including Technical Rejection Avoidance, eCTD Reviewing, eCTD Validation, eCTD Content, eCTD Readiness, Document Templates, Study Tagging Files (STFs), Granularity, and Submission Outsourcing.

We have also posted links to eCTD guidelines for the US, EMEA, Health Canada, PMDA, and TGA.  We also have links to HL7/Regulated Product Submission (RPS) information.

Speaking of RPS, GlobalSubmit is also sponsoring a free RPS Educational Presentation Series.  For access to the series, go to: http://www.globalsubmit.com/XPortal/. Then click on the presentation links on the top of the page.  After you complete a brief survey, you will have access to the series.  New material will be posted every few weeks.

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.

One Response

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  1. Shakul Hameed
    Shakul Hameed April 15, 2009 at 1:08 PM | |

    Thank you for this great work.

    Regards
    M.Shakul Hameed.

Please comment with your real name using good manners.

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