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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.
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.
Offered as sector-specific individual certificates or a comprehensive dual certificate, the RAPS Online University certificates give you the knowledge and expertise you need to advance your career in just 6-12 months combined with the self-paced flexibility of e-learning. Unlike the Regulatory Affairs Certification (RAC), an exam in which one demonstrates their regulatory skill, there are no eligibility requirements or application deadlines for the RAPS Online University certificate programs.
The dual certificate offers you a way to explore different career path options available to a regulatory affairs professional, and provides you with comprehensive foundational knowledge across sectors.
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.
1 Defining Features of Quality Certification and Assessment-Based Certificate Programs. (2010) The Institute for Credentialing Excellence.