Originally Published MX January/February 2004
BUSINESS NEWS
J&J's O'Holla Named to RAPS Post |
| Robert O'Holla |
Industry veteran Robert O'Holla, vice president for regulatory affairs in the medical devices group of Johnson & Johnson (New Brunswick, NJ), has been tapped to fill the cycle of top slots for the Regulatory Affairs Professionals Society (RAPS; Rockville, MD).
O'Holla took office as RAPS president-elect effective this January. In keeping with the organization's three-year rotation of officers, O'Holla will serve as president in 2005 and as chairman in 2006.
According to O'Holla, a key challenge faced by today's regulatory professionals is keeping up with the fast pace of technological development.
"A change in the regulatory paradigm is going to be needed if we're going to accommodate the medical revolution that many people believe we're on the verge of," O'Holla says. "The question is, what are the appropriate regulatory paradigms for the future? How can we ensure that rapid technological development gets rapid regulatory acceptance to benefit the patient as quickly as possible, and still protect the public health?
O'Holla notes that the Centers for Medicare and Medicaid Services (CMS) face a similar concern to keep up with breakthrough technologies. The relationship between RAPS and CMS, he says, is another area that is ripe for debate.
"The question for RAPS is, what is the evolving role of the regulatory professional?" O'Holla says. "Should the regulatory professional evolve into a CMS expert as well as an FDA expert, or become an expert on the interplay between those organizations? Regulatory professionals need to be asking those sorts of questions in the next couple of years."
Copyright ©2004 MX
