Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional. The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at email@example.com.
"Not All Those Who Wander Are Lost" -- J.R.R. Tolkien
As regulatory affairs practitioners, we may seem to be wandering. In reality, we're often searching: through that paper stack, those old records, CDs, DVDs, electronic listings, prior notes, or some established company or vendor-driven system to find that critical nugget of regulatory information.
"The search" is usually the middle step in the three-step process of addressing a health product development issue or an issue raised by a regulatory authority. First, we meet with our team to identify a regulatory issue. Then we usually find ourselves seeking, searching or wandering through the complex and difficult avenues of regulatory data that we know exist, but have great difficulty getting our arms around.
We are in need of everything regulatory to solve the problem—or at least address it. This is the true conundrum of the regulatory practitioner. It is quite likely that we will spend 40-50% of our time just searching for the guidance, regulatory authority commentary, or old records we seek.
In essence our lives as regulatory affairs practitioners are divided: One-half of the time we are doing our job, as per our job description; the other half, we are wanderers seeking regulatory information.
The Search for Information
If we are lucky, during the third step we quickly find the information we seek, avoiding exhaustion and frustration. We can confidently meet with our development team or senior management and provide the "regulatory path" that will solve the problem or minimize the risk.
On bad days, when we are not so lucky, the search continues well beyond the regular workday. We take work home or stay at late the office to continue the excavation of paper and electronic files. We wonder if we will ever find what we are looking for!
At this stage, we realize an important truth: If you can’t find it, then you don’t really have it.
Finding information isn't the only problem regulatory professionals need to deal with. Adding to all this is the ever-increasing need to communicate to the questioners, by text, email and other electronic means. By now others are involved and everybody wants to know: What is Regulatory thinking?
As the pressure mounts, we begin to wonder not only if we’ll find the information we seek, but will it be the most current, relevant information to guide the decision?
The Benefits of Regulatory Intelligence
Enter, the world of regulatory research or regulatory intelligence (RI) tools like Graematter and Tarius, to name a few. These RI tools can often help you to find what you are searching for more easily and dramatically lessen your wandering time.
They also perform another much needed and often overlooked function: confirmation. That is, if you’ve already found what you are looking for, RI tools can confirm or double-check your primary findings.
Finding the same thing or something very similar can be very helpful in those discussions with cantankerous team members who don't always see things your way or when you need to address serious issues with senior management.
RI tools have a silver lining: The more you use them and become familiar with searching techniques (requires updating your search habits) the less time you'll spend wandering or searching in that large sea of regulatory information and more time doing what you love, regulatory affairs!
S. Albert Edwards, PharmD, RAC, FRAPS has more than 42 years in the pharmaceutical and life sciences arenas, with 25 years dedicated to research and regulation in the food additives and pharmaceuticals. Dr. Edwards was the Director, Regulatory Affairs Operations, at Takeda Global Research & Development Center, Lake Forest, Illinois and had responsibility for Takeda’s Corporate Records Department. Since 1993, he has been an active participant in the Regulatory Affairs Professionals Society, RAPS, serving as President-Elect 2003, President 2004, and Chairman of the Board 2005.
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