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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.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
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 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.