15 February 2012

THE eCTD SUMMIT: Regulatory Submissions Made Easy, Part III - By Matthew J. Neal, Director of Knowledge Management & Innovation in Global Regulatory Affairs & Safety at Amgen, Inc

Several years later, as the lead publisher and I walked the fake DVD’s over to the Lead Regulatory Rep for a photo op (the submission was sent through the Electronic Regulatory Submissions Gateway, so there was nothing to photograph or hold) and there was calm. There was no noise. There was no mayhem. There was no U-Haul. There was no paper. We reminisced about the past and how much drama used to happen before electronic submissions. All that drama was now the press of a button. A 100% electronically QC’d, integrated package sent through the digital realm (almost) instantly. No trucks, no binders, no paper, no tape, no page stamper, no boxes. We didn’t miss it and you will not miss it either. I believe the remark was, “Oh, that’s it, huh?”. Yep, that’s it. The publishers were able to be lazy, relaxed, finished – and going home at 5:00. While we can’t always achieve the 5:00 thing – we should always aim for it. Life’s too short. Thanks for reading. 

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