eCTD Tips & Tricks Part I

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Editor’s Note: 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 GlaxoSmithKline 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 example, cast your mind to the mid-1990’s when companies were still submitting paper in quintuplicate with different colored binders and hand-stamping page numbers. One company, in a rush to get a CD-Rom full of datasets out to meet a deadline on a submission, sent instead a CD-Rom of classical music to the agency instead of data. Needless to say, the agency, while they may have enjoyed the relaxing symphony selections, was unable to review the data. I digress…

Second order of business (and probably the most important), surround yourself with people who know what they’re doing, know the software tools at an expert level, and are extremely lazy. Yes, I said lazy. Do you know why? Efficiency born out of laziness is one of the most powerful drivers of innovation and automation. Why would I want to draw thousands of links in a Clinical Study Report by hand if I could write a linking script with an Acrobat plug-in that will do ninety percent of the linking in the background for me while I finish up the formatting on other documents? Or better yet, allow the linking script to run overnight so I can go home and be with my family instead of burning the midnight oil. The bottom line – whenever possible, work smart not hard (maybe lazy was too strong).

There’s a saying in carpentry – measure twice, cut once. The same applies to regulatory submissions. QC and make sure everything works before you send it out. Spend the time and care to be sure that what you’ve spent so much time preparing is right. Believe me, the one link you forgot to check is the only one the document control room will click on before they accept your submission.

More to come in part two…

Author: GuestPost

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