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Regulatory Affairs Certification (RAC), is the leading post-academic professional credential for regulatory professionals in the healthcare product sector. It is intended for individuals employed in regulatory agencies, industry, consultancies and other settings involved with the regulation of healthcare products. Regulatory Affairs Certification tests expertise in two sectors, pharmaceuticals and medical devices, and candidates may choose whether to take the RAC Drugs exam or the RAC Devices exam. All candidates who pass an RAC exam will be equally recognized by the RAC program and will be eligible to put ‘RAC’ after their name.
The Regulatory Affairs Certification Board (RACB) oversees the development of the RAC examinations. Each examination is developed by an examination committee comprised of practicing regulatory experts knowledgeable about the relevant regulations for the region.
The RAC examinations are based on job analysis studies undertaken by the RAC program. These studies are guided by experts in testing and measurement. The job analysis studies are completed before an examination is created and repeated as needed to determine whether there are changes in the role and scope of practice of regulatory professionals that would require adjustment of the examination content. The job analysis study is used to develop the content outline for each examination and determine the number and type of questions to be included in each content area.
Questions on the examinations are updated every year to reflect current regulations, guidelines and practice. New examination content is added for the Spring testing cycle and covers regulations in effect as of 31 December of the previous year.