ABSTRACT
Founded in 1976, the Regulatory Affairs Professionals Society (RAPS) is the largest international organization of and for healthcare product regulatory professionals. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide, and can be found online at www.RAPS.org. It helped establish the regulatory profession and continues to promote its identity and prestige, operating outside the political arena as a neutral, non-lobbying organization. RAPS members help ensure the safety, effectiveness and availability of the full range of healthcare products, including medical devices, pharmaceuticals, biologics and biotechnology products, and nutritional products, as well as some foods and cosmetic products. They work in a variety of employment settings, including the companies that make and sell healthcare products; the regulatory agencies that oversee them, such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the
Singapore Health Sciences Authority, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labour and Welfare (MHLW), Taiwan Food and Drug Administration and others; academic institutions; clinical research organizations; and other companies and organizations where regulatory expertise is needed. RAPS members and regulatory professionals in general, play a myriad of vital roles throughout the lifecycle of healthcare products, from research and development to manufacturing to compliance and postmarketing. RAPS supports these individuals and the organizations that employ them by providing integrated solutions with products and services that meet the shared needs of regulatory professionals worldwide, as well as the unique local needs of different countries and employment settings. This includes education and training, professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources. It also provides Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence (www.RAPS.org/rac).
