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RAPS Offers New International Regulatory Affairs Certification - RAC (GS)

New RAC Credential Focuses on General Scope of Regulatory Practice, International Standards

ROCKVILLE, Md., April 7 /PRNewswire-USNewswire/ -- The Regulatory Affairs Professionals Society (RAPS) has announced its newest Regulatory Affairs Certification (RAC), the RAC General Scope (GS). The RAC (GS) credential denotes knowledge related to the general scope of practice of regulatory professionals in the healthcare product sector, regardless of geographic location or in which regions they may be involved. The RAC is the only professional certification specifically for healthcare product regulatory professionals. More than 5,000 have earned the credential to date.



The RAC (GS) joins RAPS' three established, regional RAC certifications covering regulations specific to the United States (US), the European Union (EU) and Canada (CAN), respectively. Like those credentials, the RAC (GS) signifies vital regulatory professional abilities and commitment to excellence in the field. Unlike the three regional RAC certifications, the RAC (GS) does not pertain to a specific geographic region.

"The RAC has become a highly respected standard in the regulatory profession," said RAPS Executive Director Sherry Keramidas, PhD, CAE. "As the regulatory profession has grown globally and regions such as Asia and Latin America have seen more healthcare product development, the need for a new RAC certification covering regulatory material beyond North America or Europe has become increasingly apparent."

RAC (GS) candidates must take an exam covering knowledge of the full product lifecycles for medical devices, IVDs, pharmaceutical and medicinal products, as well as international guidelines and standards such as those from ICH, GHTF, WHO and ISO. The first exam will be offered worldwide beginning in October.

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About RAPS

The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. As regulatory professionals, RAPS members perform vital work in all areas of the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession as a whole by providing education and training, certification, professional standards, research, knowledge-sharing, publications, networking and career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel.

SOURCE Regulatory Affairs Professionals Society (RAPS)
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