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New eCTD Resources and RPS Educational Series
posted by mr.erhabi511 @ 6:18 PM
Tuesday, April 14, 2009
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.
Thank you for this great work.
Regards
M.Shakul Hameed.