It has been a while since I have updated you on the RPS project. Back in September, I had expressed cautious optimism on being able to bring RPS to vote (ballot) in May 2011. We did not make the May 2011 ballot, thus the ballot is now delayed until September 2011.
We did not make the ballot, in my opinion, since we are still working on refining all of the requirements. We have two requirements left to be finalized; namely, being able to reuse studies and all of the components in two applications and support for the new European variation legislation.
Being able to reuse studies and all of the components in two applications will allow sponsors to create a study, define all of the components (e.g. protocol, study report body, synopsis, etc) in one application (e.g. investigational application) and refer to the study in your marketing application. This benefits sponsors since it allows them to synchronize content for a study in more than one application.
For More Information Please Click the Link:TheeCTDSummit: The Latest on Regulated Product Submission (RPS)
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