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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.
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.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray together.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Either RAC exam (Devices and Drugs) may be taken at any location. Find an upcoming exam at a location near you.
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RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
A certificate training program’s primary purpose is to provide education and training so that participants can attain defined learning objectives in a particular area of regulatory affairs. Although assessment is a part of a certificate training program, the assessment is conducted to evaluate the attainment of the learning objectives. Learn more about RAPS Online University certificate training programs.
The Regulatory Affairs Certification (RAC) is a professional certification. The primary purpose of a professional certification program is to provide an independent assessment of the knowledge, skills and/or competencies required for competent performance of a professional role. This assessment is typically accomplished by the successful completion of an examination.
When your goal is to get your resume to the top of a recruiter’s pile, having the RAC is your advantage in getting recognized for an advanced job in regulatory. The RAC stands out from continuing education, like certificate programs, because it indicates mastery and competency.
Please note, RAPS certificate programs do not confer RAC status; the only way to gain RAC status is to take and pass one of the RAC exams.
The primary purpose of any professional certification program is to provide an independent assessment of the knowledge, skills and/or competencies required for competent performance of a professional role. This assessment is typically accomplished by the successful completion of an examination.1
Each examination 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. Each examination is reviewed and revised annually, and content is updated for the Spring exam cycle. Examination content for RAC exam is based on regulations and guidelines in effect on December 31 of the year prior. So, exams taken in 2020 will be based on regulations ‘on the books’ on December 31, 2019.
1 Defining Features of Quality Certification and Assessment-Based Certificate Programs. (2010) The Institute for Credentialing Excellence.