I’d like to welcome back one of our McCormick LifeScience Consultants, LLC team members, Jacob Cooper, Quality Systems and Regulatory Operations Consultant. He just keeps coming back for more writing!
All you Jake!
Can you touch your toes? Fold yourself into a Parsva Dandasana?
Fortunately, for most of us, if we answer no, it doesn’t really affect our work. Of course, for those of us in Regulatory and Quality in the pharmaceutical industry, most of our work is essentially a dance with regulatory authorities, corporate cultures, and other individuals. And dancing requires a great deal of flexibility!
It may seem counter-intuitive to talk about flexibility in the context of a regulated industry, compared to, say, the fleet-footed fame of software development. We simply cannot go from idea to marketed product in a matter of days, let alone even one or two years. The regulatory requirements for rigorous science (e.g., clinical trial programs), well controlled manufacturing and development (Quality Management Systems), and agency review of all of the above can seem like a straitjacket.
But the regulatory environment is constantly changing.
As agencies around the world strive to fulfill their core mission of protecting the health and safety of the public, they update and refine their guidance, sometimes requiring industry to shuffle its feet to keep up. Electronic submission in eCTD format, for example, has triggered a seismic shift in industry, from data collection through the final labeling.
Every pharmaceutical company, no matter what size, has a distinctive flavor. Corporate culture is essentially every unspoken rule about how everybody we’re working with works together. And it can have a profound influence on how flexible a company is at every level. A competitive environment, for example, could encourage decision making that is riskier and more innovative, but it could also stifle creativity by prioritizing immediate successes.
In an industry as volatile as ours, many people change companies every five years at best. Contractors and consultants may work in many more different cultures, sometimes several at once. As companies revitalize their talent by bringing in new faces and outside expertise, the culture has to bend to accommodate the different perspective.
All Together Now
The longer we work in this industry, the more we learn about what we do and what we bring to the table. This presents each of us with a unique challenge, since as our bodies age, so can our habits. I’ll fess up right now that I can’t touch my toes anymore! The challenge is to remain as naive and flexible as we were ten or twenty years ago while still delivering the expertise we’ve spent that time accumulating.
The regulatory straitjacket is deceptive. Agencies require that certain things be done, but they don’t like to say how. So for every different corporate culture out there, there’s a distinctive solution to the regulatory challenges.
Without harming any cats here, part of what makes working in pharma exciting is that there are so many different ways of achieving the same goal. For instance, Case Report Forms can be electronic or paper, can have borders or not, can have any variety of layouts that are secondary to the requirements of collecting subject data. All too often, company turnover results in battles over these secondary issues.
The unique challenge of RA/QA folks is ensuring that the regulations are being adhered to while allowing flexibility in how it’s done. Sometimes it can feel like getting into the Parsva Dandasana!
- Industry must stay in step with the dance when regulatory authorities throw out a different move.
- Keep in mind how the culture of your workplace can influence decision making, and do your part to encourage greater flexibility.
- Don’t sweat the small stuff! Revisiting previous decisions, when there’s no compliance risk, can be counterproductive and actually impede progress.