Today’s entry was provided by Matthew J. Neal, Director of Knowledge Management & Innovation in Global Regulatory Affairs & Safety at Amgen, Inc. in Thousand Oaks, CA. He led the Regulatory Operations group there for seven years and managed submissions for GSK in Philadelphia, PA for 7 years before that.
Did that title catch you? Did you think I was going to reveal the secrets of pulling together millions of pages of data, reports, and information into a cohesive, user-friendly, searchable, and (one could argue) beautiful unit commonly called the eCTD? Well, sorry. There is no way to do it easily. In the upcoming several part series, I hope to take you through some of the things that I think will lead to a better experience navigating the unbelievable complexity that surrounds regulatory submissions. There’s a lot of science in there – good thing the publishers don’t have to actually read it.
Hopefully some of these tips and comments will help you not only make your submissions better, but also give you some idea of how to explain your job at parties.
First order of business, make sure that the extended team (by this, I mean everyone – the Regulatory liaison, the CMC rep, the pre-clinical teams, the regulatory writers, the senior leaders that chose the submission date randomly 2-3 years ago) understands that you will be the last one to touch their stuff and without you, the submission does not go to the agency. Also, make sure they understand that rushing it out the door may lead to it not getting filed at all. Do not be afraid to stand your ground, but choose your battles wisely. You may only get away with one threat per filing – so make sure it’s real. You are the gatekeeper. With great power comes great responsibility.
For More Information click here: THE eCTD SUMMIT:Regulatory Submissions Made Easy, Part I
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