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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Convergence 2020 has come and gone, but you can still access recorded sessions, which are available to attendees until 31 December 2020.
This year, our European regulatory community will converge online with a fully virtual program that will allow attendees to experience Euro Convergence live online from the safety and comfort of their homes.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
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RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
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.