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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.
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. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
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This three- course series examines essential topics within a quality system--Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). The GxP Bundle details the areas covered by each set of requirements and compares US and international regulations. The topics provide the foundation for product quality--critical knowledge for new professionals in regulatory, quality assurance, compliance or related departments such as laboratory management or clinical operations. Order Bundle Online
Courses included in this bundle:
Good Clinical Practice Explore the regulations for conducting research with human subjects. This course explains the role of the informed consent process in protecting human subjects and describes the roles and responsibilities of the clinical review team. It explains how GCPs were developed and cooperation efforts between the US Food and Drug Administration (FDA) and other regulatory agencies. 2–4 Hours | 2 RAC credits
Good Laboratory Practice Gain an understanding of how GLPs fit into a quality system, what types of studies are covered and how US and international GLPs fit together. This course outlines the reasons for GLPs and describes GLP components. It also compares the GLP regulations under FDA, US Environmental Protection Agency (EPA) and the Organization for Economic Cooperation and Development (OECD). 3–6 Hours | 3 RAC credits
Good Manufacturing Practice Review current Good Manufacturing Practice (CGMP) regulations for the US and EU and their impact on product quality and patient safety. The course addresses reasons for making quality products, areas covered by CGMPs, how pharmaceutical companies ensure compliance, and the consequences for failing to comply with the regulations. 4–8 Hours | 4 RAC credits