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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 chapters and affiliates worldwide.
This compilation of regulatory terms and definitions was originally derived from a set of RAPS publications covering the US, EU, Canada and international markets. It includes more than 2,000 definitions from a variety of sources, specifying the region for each, cross-referenced for easy use. Entries were selected based on their relevance to professionals involved in all lifecycle stages for biologics, medicinal products, medical devices and related healthcare products. This resource is intended for regulatory professionals, developed by regulatory professionals, and RAPS members are encouraged to share input, make additions, or otherwise provide clarity where it might benefit fellow regulatory pros.
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