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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.
To be eligible for the RAC examination you need to meet one of the following educational and professional experience requirement combinations:
Baccalaureate or equivalent first university degree and a minimum of three years of regulatory or regulatory-related work experience.*
Master’s degree and a minimum of two years of regulatory or regulatory-related work experience.*
Doctorate degree and a minimum of one year of regulatory or regulatory-related work experience.*
In addition, submission of complete application materials and agreement to abide by the RAPS Code of Ethics are required.
Membership in RAPS is not required to apply for or take an RAC examination or to maintain the RAC credential. However, members of RAPS will be entitled to reduced fees.
* Regulatory-related experience may include quality assurance, quality control, clinical research related to the approval of health products or health product project management.