Apart from the well-documented issues of heartbreak and overconsumption of alcohol, nothing gives a RegOps professsional the year-end blues like scrambing to finish a submission the last week of December. Here are some suggestions for how to avoid the blues this year. (Sorry, you'll have to work out the heartbreak and alcohol issues elsewhere.)
What Causes the Year End Blues?
A quarter of all new applications to the FDA are submitted in December. That's three times the number you would expect if submissions were distributed evenly throughout the year. December is the due date for many corporate, personal, and team goals, making the end of the year a genuinely busy time.
I think the main cause of the blues comes down to poor planning and communication. If RegOps is unable to negotiate reasonable timelines, or if teams do not communicate their plans enough in advance, you could easily end up singing the blues.
Avoiding the Blues
There are a couple strategies that can help avoid the December blues. The first is remarkably simple, and it's something that your colleagues in Accounting have been doing for years. Every November, Accounting publishes a date by which all expense reports and invoices must be turned in order to get paid that year. RegOps doesn't have the power of the purse, but there's no reason you can't follow Accounting's lead. For example, set a deadline that all scheduled submissions will go in no later than Dec 15. Of course, emergent submissions like safety reports may have to go in after that, but push to have all planned submissions out the door by the middle of the month, so that RegOps can participate in the same end-of-year activities as everyone else.
The second strategy is to communicate your timelines to everyone. Map out how long a typical submission takes to go through the publishing process, and talk about competing submissions. Explain that a team's December 31 goal doesn't mean that they get a holiday break while you work on their submission. People understand this, but if RegOps isn't represented when they create their timelines, you could end up singing the blues.
Finally, on those big, corporate goal submissions, map out the process so that an end of the year deadline means all documents are delivered to RegOps by the end of November. This may take some negotiation so start early.
This stuff seems obvious, but keep reminding people every chance you get. If you want to relax by the pool sipping drinks out of a coconut next December, lay the groundwork now. There may be some submissions where the data comes in late and you have to work over the holidays. With some up-front strategy and a bit of follow through, you can make that the exception, not the rule.
Happy new year to all my Regulatory Operations friends and colleagues. I hope this is a joyous and successful year for you, and that next December is a good one, not a blue one.