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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. 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.
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with chapters and affiliates worldwide.
Develop and sustain a competent global regulatory workforce that drives good regulatory practice and policy to advance public health.
The RAPS Board of Directors is the governing, policy-making and strategic body that guides RAPS in serving the regulatory professional and the regulatory profession around the world. The Board of Directors has the legal and fiduciary responsibility to ensure the longterm viability and integrity of RAPS. The Board of Directors plays an integral role in maintaining a system of checks and balances that enables the organization to make strategic business decisions.
Volunteer for the RAPS Nominating Committee. Contact nominations@raps.org for more information.
Learn More
RAPS 2019 Board of Directors Begins Term; Don Boyer Takes Helm as Chair, 18 January 2019 --- RAPS Welcomes Utah Chapter, 1 November 2018 RAPS Introduces Pharmaceutical- and Medical Device-Focused Regulatory Affairs Certifications, 3 October 2018 RAPS Releases Results of Compensation Survey of Regulatory Professionals, 3 October 2018 John Lim, Justina Molzon, Barbara Schneeman and Mike Ward to Receive RAPS’ Highest Honor, 2 October 2018 RAPS to Honor Lena Cordie, Alan McEmber for Outstanding Community Leadership, 28 September 2018 Daniel Mannix, Sandra Matsumoto and Frank Pokrop Named RAPS Fellows, 27 September 2018
As the international leader for the healthcare regulatory profession, RAPS has initiated and supported the development of this code of ethics for the profession. Following a series of surveys and focus groups held over two years, a task force of volunteers was convened in February 2003. Their work, reviewed and shaped by many regulatory professionals, forms this code.
Read Code of Ethics
New EU regulatory changes are coming: Here’s what you need to know by Fink Densford, Medical Design & Outsourcing, 2 January 2019 --- HHS Recommends Co-Prescribing Naloxone With Opioids by Joyce Frieden, Medpage Today, 20 December 2018 Medtech Losers of 2018 by MDDI Staff, Medical Device and Diagnostics Industry, 19 December 2018 Waiting in the shadow of a no deal Brexit Manufacturing Chemist, 19 December 2018 MDR: Market disruption on the horizon MedTech Engine, 11 December 2018 FDA Approves NIH-Funded Genetic Database, Issues Draft Guidance on NASH Pharmacy Choice, 7 December 2018 Disruption of the Year: EU regulatory overhaul by Meg Bryant, MedTechDive, 3 December 2018