In the clinical research industry many rely on a regulatory strategy, or a regulatory plan. Having a strong foundation to build upon for a research team is vital for success. When regulations are the building blocks the goal of compliance can be more readily achieved- and in the end, keep patients safe. This is the main objective of our industry; how can it be realized?
Tim Felgate, is a regulatory affairs consultant, specializing in regulatory intelligence, with 20 years international experience. In a recent blog posting, he sheds new light on the term regulatory intelligence. A key sentence caught our attention; it reads “Regulatory intelligence is a key part of helping to ensure that resources are appropriately focused to help companies develop effective medicines for treating patients.” But what exactly is regulatory intelligence?
- Gathering key or significant information
The first key point focuses on the acquisition of information. This can mean researching governing bodies’ rules and regulations, to researching what industry thought leaders have published on a particular topic. Knowledge is power, and the more information obtained can lead to sound decision making,
- Processing/analyzing information to understand its relevance
Another area to consider is the analysis of the information collected. Picture a filter or a funnel; at this step all the data collected must be sifted to find what is relevant and helpful, versus what is just background noise. The author points out that consideration should be taken in the fact that regulations and standards may vary from country to country.
- Finally, developing a regulatory strategy
Next is to develop a strategy. As stated in the blog, “As the regulatory landscape is constantly changing and the product characteristics become better understood, it is essential to keep revisiting and updating the strategy in the light of new evidence.” So, in essence a regulatory strategy should be a living document that allows the flexibility for the first two points to continue to flow and for adjustments to be made.
While many in our industry have coined definitions for regulatory intelligence, it may be described best in the closing of a blog as the author states, “I believe the primary concern in regulating medicines is the correct acquisition and application of knowledge…These imply it is not just gathering information, but it is more importantly what you do with the acquired knowledge to inform the best approach to the development, and regulation, of much-needed medicines. Ultimately the goal is to benefit patients by ensuring optimal regulatory strategy.”
Check out the complete article by Felgate. What are your thoughts on regulatory intelligence? Do you have any points to add? Share below!
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