RAPS' New Regulatory Competency Framework Helps Organizations, Individuals Plan Professional Development, Training, Career Advancement

ROCKVILLE, Md., April 7, 2016 -- The Regulatory Affairs Professionals Society (RAPS) today released its new Regulatory Competency Framework, a tool to help design training and map professional and career development plans for regulatory professionals. The one-of-a-kind Framework is beneficial for individual professionals as well as regulatory employers and academics developing curriculum and education.

The Framework was previewed during last October's 2015 Regulatory Convergence conference. In his opening remarks, then-RAPS Chairman Rainer Voelksen told attendees: "Think about the nature of your work. It's not merely based on memorizing regulations. It is based on critical thinking, effectively integrating science, regulation, law, communication and business acumen. Your education and training needs to reflect this."

RAPS' Regulatory Competency Framework outlines a shared set of competencies for the profession, including knowledge and the necessary skills to apply it. Applicable across the globe, the Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels, and breaks down the basic competencies into clear, easy-to-understand statements, providing a foundation for individuals and organizations to customize their plans.

Several multinational organizations already have begun using the Framework. Former Chairman of RAPS' board of directors, Sue James, who is a vice president with GlaxoSmithKline (GSK), has used it to help define regulatory roles at GSK and called it "enormously valuable." "I leveraged the RAPS Regulatory Competency Framework to ensure alignment between GSK's competencies for regulatory staff and those identified by RAPS," said James. See the full interview with James at www.raps.org/Regulatory-Focus/RAPS-Latest/2016/04/07/24723/GSKs-Sue-James-Praises-RAPS-Regulatory-Competency-Framework.

To learn more about RAPS' Regulatory Competency Framework, or to request a copy, go to www.RAPS.org/rcf.

About RAPS

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Shanghai and Singapore, and chapters and affiliates worldwide. www.RAPS.org

CONTACT: Zachary Brousseau
         Senior Manager, Communications
         RAPS
         +1 301 770 2920, ext. 245
         [email protected]