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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.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
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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Each exam is based on a survey of the scope of practice and specific roles and responsibilities of regulatory professionals in the workplace with at least three years of regulatory experience. The specific content of each examination includes performance domains, tasks, and associated knowledge and skills and is based on a job analysis, statistical/psychometric analyses guided by subject matter and testing experts. The questions on the RAC exams are updated every year to reflect current regulations, guidelines and practice. Each year's RAC exams are based on regulations ‘on the books’ on December 31 of the prior year.
The examinations consist of 100 multiple-choice questions, answered in a two-hour time limit. All RAC questions and content are written in English.
There are three question formats which may be used in the RAC Exams:
While the examination content outlines may be used for a period of several years, the 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.