Posted 24 January 2018 | By
This article discusses ways in which the regulatory intelligence professional can monitor, identify, analyze, interpret and “stay on top” of regulatory trends to best develop regulatory strategies aimed at maintaining the organization’s regulatory compliance readiness. Sources to help identify regulatory trends as well as ways to develop skills for trend analysis and interpretation are examined.
One fundamental responsibility of regulatory intelligence and policy professionals is to monitor, analyse and interpret the “regulatory environment.” Interpretation is critical for product or project regulatory strategies as it allows regulatory leads to be up-to-date when designing regulatory strategies. Interpretation also allows teams to place those strategies into a context far wider than regulatory, and ultimately, allows the organization to “map” regulatory “knowns and unknowns.”
No environment is static. Any regulatory analysis, investigation or research carried out on a certain topic is but a “snapshot” in time, especially in times like the present when both legislative and regulatory environments are shifting rapidly as advanced therapies, new treatments for high unmet medical needs, and new, digital technologies emerge.
Regulatory intelligence and policy professionals are particularly well-placed to ensure the organization “knows what it knows.” But more importantly, by identifying and acting upon regulatory trends as they present themselves, regulatory intelligence professionals also can help the organization to “know what it will need to know” in the future.
About the Author
João Duarte obtained his pharmacy degree in 2011 from the University of Lisbon and has been working in regulatory intelligence and policy for more than five years since. He is currently associate director for Europe regulatory policy and intelligence at Takeda. Duarte has been an active contributor to associations, such as RAPS, since 2014 and is currently part of the Planning Committee for RAPS Convergence 2018. He may be reached at firstname.lastname@example.org.
Note: the author would like to acknowledge and thank Linda Bowen, senior director, global regulatory science and policy at Sanofi for her contribution and input for this article.
Disclaimer: the information and views set out in this article are those of the author and do not necessarily reflect the opinions of his current or past employers.
Cite as: Duarte, J. “Monitoring, Analyzing and Interpreting Regulatory Trends.” Regulatory Focus. January 2018. Regulatory Affairs Professionals Society.