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試験科目：Regulatory Affairs Certification (RAC) Global Scope
問題と解答：全100問 RAC-GS 日本語的中対策
New RAC Credential Focuses on General Scope of Regulatory Practice,
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
For more information, visit www.raps.org/rac.
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.