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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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The Regulatory Basics bundle is ideal for new professionals, students and career transitioners who need to learn the core concepts and key principles for operating in the health product sector's regulated environment.
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.
Select which bundle option is right for you:
Courses included in this bundle:
Role of the Regulatory Professional Examine the evolution of the profession and a professional’s roles and responsibilities. It also outlines critical events and their impact throughout the product lifecycle for drugs, biologics and medical devices. 1 Hour | 1 RAC credit
Pharmaceuticals: Definition and Lifecycle Learn basic terminology as well as the lifecycle development stages including early-stage research, nonclinical and clinical trials, manufacturing, marketing and postmarketing. 1–2 Hours | 1 RAC credit
Medical Devices: Definition and Lifecycle Gain an introduction to general aspects of product and regulatory lifecycles. It also provides a brief history of medical device regulation and information on basic regulatory principles and concepts. 1–2 Hours | 1 RAC credit
Introduction to Regulatory Affairs in the EU Get a basic understanding of the regulatory requirements to obtaining marketing approval for healthcare products––Centralised Procedure, Decentralised Procedure, Mutual Recognition Procedure National Procedure as well as approvals performed by Notified Bodies (NBs). 1–2 Hours | 1 RAC credit
Introduction to Regulatory Affairs in the US and Canada Learn about the agencies primarily responsible for regulating healthcare products in these countries—the US Food and Drug Administration (FDA) and Health Canada and review applicable legislation that drives their regulatory processes. 2–4 Hours | 2 RAC credits