eCTD Tips & Tricks, Part III
Hey Everyone. It has been a few months since my last entry. I trust your holidays were enjoyable. Hopefully you didn’t think about work too much. That’s what this final chapter is going to focus on, actually – not thinking about work.
In the previous installments, I talked to you about the tools and teams to help you make regulatory submissions easy. But since I’m going to assume that since I left you alone there for a few months that you’ve already got that finished and we can move on to the most important part – becoming the laziest team in your organization.
As you may recall, in Part One, I said “Efficiency born out of laziness is one of the most powerful drivers of innovation and automation.” The only way to get to the point where you are not thinking about work is when you know your team is a well-oiled machine that will not break down. You know you have the right tools, people, and process.
The biggest stress and source of difficulty, of course, is waiting for final documents. While this is a concern for every Regulatory Operations team, in the grand scheme, you have no real control over this common phenomenon. So, the best you can do is be ready to react and have confidence in your team to work quickly and efficiently when the documents finally come through. The good news is, while you’re waiting – you can relax (more not working) knowing how well your Operations machine works.
I would like to close this series with a story that will give you hope (I hope). When I first joined the wacky world of Regulatory Operations a long, long, time ago, a Marketing Application event was monumental and scary. The sounds coming from the assembly area were loud and striking. Hole punchers, printers, and page number stampers echoed through the building for weeks leading up to the submission date. Multi-colored binders flew up in the air, paper cuts were rampant, and the little rubber fingers for checking pages stayed on in all situations. As the day really approached, the sound of boxes being assembled and tape guns furiously sealing up a mountain of cardboard replaced the earlier mayhem. Tape guns was a great sound to hear, until someone came running in with a late breaking change…then the ripping sound made everyone sad. Soon, a U-Haul was loaded with boxes and team photos were taken and the waiting began.
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.
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 GSK in Philadelphia, PA for 7 years before that.