Rockville, MD, USA—The Regulatory Affairs Certification Board (RACB) has changed the name of its “General Scope” Regulatory Affairs Certification (RAC) exam to the “Global” exam to provide a more accurate and clear reflection of the knowledge tested. The exam content itself has not changed. The RAC is the only recognized post-academic, professional credential for the healthcare product regulatory field. The exams and the criteria for maintaining the credential are developed, managed and administered by the RACB through the support of the RAC Program Office within the Regulatory Affairs Professional Society (RAPS).
The newly renamed RAC (Global) is one of four RAC credentials available, and it is the only one that does not pertain to a particular country or region. The other three RAC credentials cover regulations specific to the United States (US), the European Union (EU) and Canada (CAN), respectively. The RAC (Global) exam focuses on knowledge of regulatory functions throughout the healthcare product lifecycle, with reference to global standards—from ICH, GHTF (through IMDRF), WHO and ISO—commonly used in global harmonization or alignment initiatives by regulatory authorities around the world.
“The RACB, the independent body responsible for overseeing the RAC Program, believes that the previous name for this exam did not clearly communicate the nature and content of the credential,” said Susan DeCorte, RAC, senior director, worldwide regulatory affairs, Pfizer Inc., and RACB chair . “Global standards are increasingly important as medicine and medical products are produced and marketed around the world. The RAC (Global) focuses on these international standards.”
Registration for the spring 2013 RAC exam period, 1 April–31 May, is currently open through 8 March. More information is available online at www.RAPS.org/certification.aspx.
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 Europe and Asia, and chapters and affiliates worldwide. RAPS.org