BOSTON, Oct. 1 /PRNewswire-USNewswire/ -- The Regulatory Affairs Professionals Society (RAPS), the leading organization devoted to the global healthcare products regulatory profession, announced at their annual conference here last week the release of "Regulatory Affairs Professional Development Framework: An Overview," a new white paper describing the knowledge, skills and abilities of regulatory professionals.
The white paper, introduced by RAPS' Executive Director, Sherry Keramidas, PhD, CAE, during a Tuesday morning keynote session at RAPS 2007 Annual Conference & Exhibition, builds on several years of research conducted by occupational analysts and by experts in the regulatory field. This marks the first time descriptions of regulatory affairs career levels, including major responsibilities with associated knowledge and skills in related areas, have been consolidated in a report.
RAPS has defined and shaped the profession since RAPS' founding in 1976. While research and analyses of the regulatory profession have always been a hallmark of RAPS, the release of the paper is a significant achievement for the organization
"This white paper represents a milestone for RAPS and for the regulatory profession," said RAPS' Executive Director, Sherry Keramidas, PhD, CAE. "The framework and report are important building blocks in RAPS' efforts to research and create a comprehensive description of the regulatory affairs professional."
As explained in the white paper, the Regulatory Affairs Professional Development Framework describes the knowledge, skills and abilities required at four different stages of professional development throughout the product lifecycle. The framework defines the profession in terms of career levels. Within each career level, it describes domains or steps in the healthcare product lifecycle, responsibilities and tasks of the RA professional at each level, and associated knowledge and skills.
Keramidas said the fr
|SOURCE Regulatory Affairs Professionals Society|
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