Pandemic Brings About Change In Regulatory Science

Despite severe pressure arising from the coronavirus pandemic, global health regulations could be a beneficiary in the new normal, says a leading US health authority.

“We are seeing a broader interaction between industry and the regulator as a result of Covid-19,” says Susan Winckler, CEO of the Reagan-Udall Foundation for the US Federal Drug Administration.  “As this travels the world, we will see more rapid decisions being made in s structurally lengthy process.

Speaking at a Life Sciences and Health webinar held by the global executive recruiter Cornerstone International Group, Winckler cited ways in which the regulatory process is being improved by the impact of Covid-19.

“There is a growing acceptance of what is called real world evidence,” she says.  “This is where the information we gather about product or test performance includes real-life data from electronic health records as well as data from formal screening and diagnostic tests.”

Another improvement is the significant progress being made in harmonizing global standards.

A life science company has to work with many different regulators having different requirements around the world. A pandemic by definition brings the global healthcare authorities together and they learn quickly how each works and how adjustments can improve or speed up a process.

“The new normal that the post pandemic world brings may be quite different,“ says Winckler. “I think particularly in the acceptance of real world evidence, and in the need for regulators and regulated industry to interact even more extensively than they typically would.”

The Life Sciences and Healthcare practice is one of several talent specializations of Cornerstone International Group and recently published a major global report on challenges facing the industry.