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‘Compliance’ is part of the solution

In pharmaceutical industry, it predictably pops-up from time. Sometimes very open and accusingly. And sometimes more between the lines. Complaints about ‘compliance‘ being a road-blocker for doing new or different things. Standing in the way of innovation.

What a wrongheaded old-school thinking!

Let’s initially remember the very good reasons why we have compliance in game …

  • Our common goal is to ensure that every single patient gets the right, the safest and the most efficacious treatment for his conditions. For me personally, this is a very selfish expectation, as we all – and our families and friends – are patients some day. And we all expect to get the best treatment possible.
  • Compliance’s role is to care that external regulatory rules & expectations – aiming at that goal – are met. The internal responsibility is with dedicated ‘compliance’ and ‘legal’ functions and roles.
  • Many of those external rules are in place due to actual misbehavior by our industry over decades in the past.

Based on that, let’s quickly rethink: When facing a push-back by ‘compliance’, is ‘compliance’ the issue? … or could it be that you simply did not do your job properly?

Over the years, I watched huge projects and initiatives been pushed forward while generously ignoring external and internal compliance needs and requirements. Then, close to the project finalization, there was the frustration of running against a wall that simply had not been sufficiently considered before. And the typical reaction seen was people complaining about’ compliance’. Between me and you, don’t blame others for your own failure and self-created frustration. Interestingly, some people seem to be stuck in repeating this over and over again. … perhaps they love the pain.

I personally do not. So I started understanding …

Compliance as an enabler

I really invite us all to disrupt the old thinking of compliance as a road-blocker and to start seeing compliance as a powerful enabler.

For me, ‘compliance’ and ‘legal’ colleagues can help to very early(!) define the playground. You can then still play your full creativity on that playground. But the boundary lines a set and clear. And it is agreed that there is just one ball on the field, where it is understood what happens when the ball crosses the line. Also the number of players, the sizes of the two goals, and how to score are clear. And it doesn’t stop the teams from playing great, creative and exciting football.

Key is to early ask “how would my playground look like allowing me to play and achieve my goal”?

your your defined playground
Source: Mohamed Hassan/Pixabay
3 rules for effective collaboration with compliance & legal

Guided by colleagues over the years, I learned to love the guidance provided by compliance colleagues as guidance for doing the right things the right way on an agreed playground. And I came to the following 3 rules which allowed me to deliver a series of assets and innovations …

guidance for preventing compliance issues with your projects
©2022 Christian Velten

That is it. I promise you that – by following those simple rules – your life is getting easier.

Make compliance your partner, who is helping you to define the playground. A playground where you can still play your full creativity and innovation power, but without the risk of getting a rebuff after having invested months of work. And I promise you that our compliance colleagues will appreciate, as no-one loves being seen as “Dr. No” but instead feeling being included in a joint ambition.

Compliance is part of the solution.

At this point, I would like to give some flowers to those ‘compliance’ or ‘legal’ colleagues who supported me over the years … and investing some time in allowing me to better understand.

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