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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.
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.