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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.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray 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. Either RAC exam (Devices and Drugs) may be taken at any location. Find an upcoming exam at a location near you.
Demonstrating Regulatory Value
18 February 2020
Estimating the Probability of Regulatory Registration Success
13 February 2020
The Changing Role of the Regulatory Professional
12 February 2020
How the Role of Regulatory Operations Professionals Will Evolve in the new Decade
11 February 2020
Writing Informed Consent Documents: A Balancing Act
06 February 2020
Why Understanding Regulatory Affairs is Important to key Company Decision Makers
05 February 2020
Economic Operators: Roles and Obligations Under EU’s MDR
04 February 2020
Changing Regulatory Landscape, Strategy and Global Policy
03 February 2020
Regulatory Affairs Consultants: Who Needs Them and Why
24 January 2020
[Updated] The Changing Regulatory Landscape for Insulin
23 January 2020
Drug Development Process for Biologics: Regulatory Expectations
22 January 2020
02 December 2019
20 February 2020
19 February 2020