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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.
The RAC examinations are challenging, so it is important to develop a study plan to prepare for the examination. Your plan should be based on your knowledge, experience and preferred approach to learning. You do not need to be registered for the RAC exam in order to start preparing.
Here are some things to consider:
Review the examination content outlines. Each examination content outline contains the content domains, competency statements and number of questions in each domain. Exam questions are based on guidelines and regulations effective 31 December of the prior year.
Assess the scope and depth of your knowledge and experience. Use the content outline as a checklist and evaluate your areas of strength and weakness. This will help focus your study on the areas you need most. Build and implement your plan. Allow sufficient time to build your knowledge base in areas where you have limited experience and to expand your knowledge in areas more familiar to you. Use reference materials to supplement your knowledge.
Important note: RAPS does not state or imply that RAC preparation materials provided by RAPS are the best or only means of preparing adequately for the RAC examination. The purchase of preparation materials is optional, and no advantage is given to candidates who participate in preparation materials provided by RAPS over other materials or methods. Neither RAPS nor the RAC program states or implies that these education or training programs are the only or preferred route to certification.