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.
Regulatory professionals know that what it takes to succeed is, more than anything else, intelligence. Being successful in this rigorous field of science, communication and strategy requires a lot of mental horsepower. But while we traditionally think of measuring intelligence in terms of IQ, perhaps we need to start thinking of our ability to succeed in regulatory in terms of our regulatory intelligence quotient—our capacity to make sense of regulatory data and turn it into actionable information.
And that’s essentially the definition of regulatory intelligence—actionable intelligence derived from assessment of the regulatory landscape. In this definition, the regulatory landscape can encompass various types of publicly available information, such as:
- product approvals
- adverse event reports
- guidance documents
- recent actions taken by government agencies
The emerging field of regulatory intelligence has such tremendous capacity to inform the regulatory process that it should be an essential component of every regulatory professional’s toolbox.
If it were possible to improve submissions such that questions from the US Food and Drug Administration (FDA) were reduced and therefore review times minimized, wouldn’t that be a great advantage? How about getting the scoop on the competitive environment for a particular product code or type? Regulatory intelligence can provide the information needed to accomplish these things, and many others as well.
Electronic Regulatory Data: A Game-Changer
The abundance of electronic regulatory information now available is changing the game. In the not-too-distant past the process for obtaining regulatory documents was, well, slow. Very slow. Imagine faxing (yes, faxing—remember that?) a Freedom of Information (FOIA) request to FDA and then waiting… and waiting… until by the time the document is finally received, many months later, it’s no longer relevant—the opportunity has passed.
In this age of terabytes and petabytes of data (see Fun Fact below), millions of documents are instantly available online, and with the right analysis, they can deliver a wealth of insight.
While this massive amount of data allows for great opportunities, it also presents some challenges. The data are provided in hundreds of separate public databases that are not cross-referenced, so finding correlations between items such as adverse events and recalls can prove difficult. A lack of ability to search within text is also a handicap. Fortunately, there are new tools available that enable the regulatory professional to gain regulatory intelligence with minimal resource investment. Examples of data and intelligence that can be derived from various sources will be provided throughout an upcoming series of articles in Regulatory Focus.
Regulatory Data: Potential Uses
Some of the many ways regulatory data can be useful include:
- Detecting “hot button” issues that a particular FDA district office is frequently citing in inspection reports, allowing industry to ensure all bases are adequately covered.
- Surveying the competitive landscape to inform regulatory strategies as well as business intelligence.
- Monitoring approvals to keep on top of new products, providing valuable input regulatory professionals can utilize and also arm feed to sales and marketing.
- Learning when labeling changes are made to competitive products, to assess whether the changes might impact the market.
- Analyzing adverse event reports to see what’s trending in the field.
- Assessing review times for a category of product or reviewing division to detect trends and compare results.
- Keeping up with Warning Letters that might affect the market and to see shifts in policy implementation.
- Screening potential suppliers or distributors to guard against supply chain interruption.
- Monitoring adverse event and recall data to detect problems in similar products to better inform the design process for new ones.
- Keeping current with the evolving requirements in Guidance Documents.
- Aiding in the selection of clinical investigators.
These are only some of the facets of regulatory intelligence that can be employed by the regulatory professional to improve outcomes, and each will be addressed in more detail in the coming months. In this ever-changing regulatory world, one thing is certain: more data will be made available, and industry will begin to utilize it to create a smarter and more strategically competitive environment. The high IQ regulatory professional will recognize this and put this vital key to regulatory achievement to work in the 21st century.
Next up: Top Five Ways to Use Regulatory Intelligence
Fun Fact: It is estimated that the human brain’s ability to store memory is equivalent to about 2.5 petabytes of binary data. For comparison, if your brain worked like a DVR, that‘s enough capacity to hold three million hours of video, for more than 300 years of continuous viewing.1
Your input is requested! If you have questions about regulatory intelligence or suggestions as to what you’d like to see analyzed, please let us know (for example—does the month a submission is filed affect the review time? Are the number of 483 observations cited by an FDA district office increasing or decreasing over time? What do you look for in competitive intelligence?). To suggest topics, let us know what you think, or request more information, email firstname.lastname@example.org or connect with us on LinkedIn, Twitter and Facebook.
1 Reber, Paul (2010-04-01). “What Is the Memory Capacity of the Human Brain?” Scientific American. Retrieved 2014-05-15.