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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.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
The RAPS store will be under maintenance Saturday, 29 February between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
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.
Stay informed on the latest healthcare regulatory news through RAPS’ online magazine, Regulatory Focus and its companion daily e-newsletter RF Today, or by following RAPS on social media, including Twitter, LinkedIn and Facebook.
Reporters, bloggers and other members of the media interested in covering RAPS events or programs should contact Zachary Brousseau, senior manager of communications, at zbrousseau@raps.org or by calling +301 770 2920 ext. 245.
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
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