Thoughts on Global Medical Affairs
Now for a topic no one wants to talk about but everyone should become more familiar with – Standard Operating Procedures. The hard truth of today’s world is that SOPs are no longer optional for MA. In fact, SOPs are critical for success in today’s global MA. In this post, I will discuss SOPs in general as well as share some do’s and don’ts for developing effective MA SOPs.
Our brethren in Clinical Development have been living in a world of SOPs for much longer than MA because their work was more explicitly regulated. When you are regularly audited by agencies looking for an excuse to delay the marketing of your next blockbuster, you are highly motivated to have whatever documentation they are looking for. And, in CD, that means SOPs that clearly demonstrate that all clinical trials are conducted following GCP and other related standards.
In MA we used to be less concerned about regulation enforcement, but those days are over. So, what is the state of MA’s SOPs? If your environment is like those in my experience, the answer is a mixed bag. Many organizations have some good SOPs but few organizations would claim their SOPs are simultaneously:
Most MA leaders will tell you it’s important and on the organizational To Do list but it rarely seems to rise up to the top of that list and almost nothing below number 3 on that list can get addressed in any given year.
Yet SOPs represent one of the very best defenses any organization has to arguments that it is operating contra to regulations. By having clearly defined processes that are compliant, a training program to show that people learned and understood those processes and a program to ensure that those SOPs remain updated, the organization has a very strong argument in its favor, even if a single actor is caught performing incorrectly, the argument can be made that it is a single bad actor not an institutional problem.
But SOPs are not just defensive in nature. When well done, SOPs represent an opportunity to capture best practice and apply that best practice on a global level. Every country, every region does not need to re-invent the wheel. What we do in MA is standard enough that we should be able to build a single optimized approach that we can apply on a global basis.
When building SOPs there are some definite Do’s and Don’ts.
SOPs in MA – not a topic anyone gets excited about tackling. Yet, SOPs are going to grow increasingly important as the regulatory burden on MA grows.
What is your experience with MA SOPs? Leave a comment and let me know!