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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.
Fundamentals of International Regulatory Affairs, Fourth Edition, has been updated and expanded to reflect the numerous changes in the worldwide regulatory environment. It includes details on requirements in more countries and regions than previous editions, details on the new EU Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation and features a new chapter focusing on pediatric drug development. Almost three dozen authors from around the world contributed to the new book, adding new information on all areas of the regulated healthcare product industry. This is an excellent reference book for anyone working in international markets. It also is a useful study tool for those planning to sit for the RAC exam.
Table of Contents
The Fundamentals of Regulatory Affairs Series provides a global perspective on regulatory practices, with books on Canada, EU and the rest of the world, as well as publications focused on pharmaceuticals, biologics and medical devices.