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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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As part of an effort to improve the US Food and Drug Administration’s (FDA) medical device submission process, the agency on Friday ...
Help your organization maintain an edge with the latest actionable information
Know how to efficiently gather and analyze publically available regulatory information.
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Effectively communicate relevant, actionable intelligence to key stakeholders.
Proactively influence regulatory policy in alignment with organizational objectives.
Measure and report on Regulatory Intelligence activities to ensure they add sufficient value.
18 Dec 2019
15 Jan 2020 | Fort Washington,USA
15 Jan 2020 | Santa Clara,USA