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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.
FDA Announces new TRG Rapid Inquiry Program
14 August 2019
China’s State Council Publishes Updated “Measures” for the Administration of Human Genetic Resources
12 August 2019
Professional Development: Benefits of Obtaining Professional Qualifications
07 August 2019
eCTD Submission Management
05 August 2019
Critical Thinking and Leadership Skills for Regulatory Professionals
01 August 2019
Changing Global Regulatory Landscape and Strategy for Drug and Device Operations
29 July 2019
Medical Device Cybersecurity Regulatory Pathway
26 July 2019
EU Accelerated Pathways
25 July 2019
China NMPA Publishes new Notification on Regulatory Inspection and Analytical Testing Documentation
23 July 2019
FDA and EU GMP Annex 1 Differences in Cleanroom Specifications
22 July 2019
India’s New Drugs and Clinical Trials Rules: An Industry Perspective
19 July 2019
31 July 2019
19 August 2019
16 August 2019
20 August 2019
15 August 2019