Regulatory Focus sat down Thursday with Sherry Keramidas, PhD, FASAE, CAE, who for the past 20 years has run the Regulatory Affairs Professionals Society (RAPS) as executive director but will be signing off at the end of January.
Keramidas’ extensive work in the regulatory affairs profession has broadened not only the scope of the field and the work undertaken by regulatory professionals, but she also helped to develop a certification program for the increasingly globalized industry, a conference devoted to regulatory professionals and numerous other studies and initiatives that helped the profession develop and mature over the past two decades.
“When I first came on, there was a great emphasis on the submission side and preparing for work with regulators,” she said. “Now we’re seeing an increasing engagement of experienced regulatory professionals in management, decision making and policy-related decision making,” she added, noting the launch of the RAPS Executive Development Program affiliated with the Kellogg School of Management at Northwestern University.
Keramidas also said that over her tenure she’s seen a shift in how more regulatory professionals are now engaged in the full lifecycle of healthcare products and how companies have developed more complex regulatory strategies that include other, related areas such as clinical, marketing, manufacturing and other facets of the drug and device development process.
“One of the major themes that I saw in my tenure was the change in thinking about regulatory as a job versus a profession,” she added, noting the change came about in the late 1990s. And now she says there’s a real interest in the profession from well-educated and trained individuals in the fields of medicine and research.
As far as the shift in global regulations Keramidas has seen, she said the nature of science has become more complex, which is underlying what’s going on in these products and has meant the regulations have to adapt.
Regulators are going to need more adaptable approaches to regulations, particularly as products become more “personalized,” she said, noting that “the regulations aren’t going away.”
Though at the global level, she also made the distinction that regulators are looking more to convergence rather than harmonization, adding that “it’s a shared set of principles and approaches based on sound science….[and] not that all regulators adopt the same guidance but that we’re at the same starting point.”
“We need to understand how can we converge across geographic boundaries and identify shared similarities so it’s not every country or region re-inventing the wheel,” she added.
And on the question of what she’s most proud of during time at RAPS, Keramidas is quick to say that she’ll miss all of the people she interacted with and that she’s proud the organization has played a critical role in the birth of the regulatory profession, in engaging with regulators and industry from a neutral standpoint and in helping regulatory professionals grow and develop.