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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.
RAPS Convergence is going virtual. Join the brightest minds in regulatory online to gain the latest knowledge in the field in an all-virtual experience with workshops, one-on-one expert sessions, and networking communities.
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.
The last exam window of 2020 is currently open. Register by 8 October to take the RAC exam this autumn.
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RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
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