RAPS 2012 Attendees Focused on Electronic Submission Mandate

I recently attended the RAPS 2012 annual meeting in Seattle, and had the opportunity to speak with many different regulatory professionals from all over the country. One of the main themes that seemed to be on everyone’s mind was the impending PDUFA V mandate on electronic submissions. Based on the information gathered from the sessions and around the exhibit area, it is clear that there is some trepidation as to how to manage...

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Notes from RAPS Advanced eCTD Workshop

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...

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