Japan Presentation Compares eCTD to RPS

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I was not able to attend the HL7 Working Group meeting in Japan last week, but I did give an RPS education session remotely.

The agenda including the background of RPS, the foundation of the standard, document lifecycle, release two of the standard and a comparison of RPS to eCTD.

In the background section we discussed the goal, scope, how the project was initiated and the project’s acomplishments.

In the foundation section we discussed how submission are tied together for regulatory activities (e.g. approvals) and how multiple regulatory activates are tied together (e.g. for one product).

In the document lifecycle section we discussed how document are handled with in RPS and how to assign keyword (e.g. study title, manufactures) to documents.

We then discussed the status of release 2 of RPS and went in to some detail about two-way communication, approvals, country specific documents and product information.

We ended the session with a comparison of RPS to eCTD and briefly discussed how one can convert an eCTD to RPS.

I have posted this presentation to my RPS educational page (http://www.globalsubmit.com/XPortal/Presentations/PresentationsLogin.aspx). Every few weeks I add new educational material about RPS.



Author: Jason Rock

Jason Rock is a pioneer in the field of electronic submissions. Mr. Rock has an extensive background working with global life sciences companies and regulatory agencies to promote eCTD adoption through the development of advanced applications. The commercial software Mr. Rock originally developed, and continues to improve, in his role as Chief Technical Officer for GlobalSubmit, is used exclusively by the U.S. Food & Drug Administration to review and validate all eCTD submissions the FDA receives.

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