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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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RAPS course bundles consist of relational topics that intersect in practice. Bundles offer a quick and cost-effective option to build expertise in a defined area.
The courses provide fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets. Paired together, these courses serve as an excellent foundation for regulatory affairs knowledge.
Regulatory and medical writing is an integral part of the product development and approval process. It is a skill that must be honed and refined as you gain regulatory knowledge and experience. Learn more about the components of various application types and techniques for improving document quality.
Looking to improve your knowledge surrounding the proper conduct of clinical research with human subjects? You’ll learn more about the fundamental requirements for major markets, the role of the informed consent process, types and phases of clinical trials and protocol development, roles and responsibilities of parties involved in clinical research and issues related to trial management and safety monitoring.
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.
The Medical Devices Postapproval Bundle links together three critical regulatory compliance activities following completion of the medical device product realization process --post market surveillance; post-release risk management; and corrections, removals and directed recalls. Intended for experienced regulatory, quality systems, medical affairs, legal, compliance management, and product development engineering personnel, this set of courses provide an examination of the applicable regulations, requirements and health authority reporting criteria across each of the three areas for the US, Canada and European Union.