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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.
Resources, news and special offers to support you and your professional development during this difficult time.
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.
Updated by a group of distinguished regulatory experts, this new edition is a must-have handbook for regulatory professionals at all levels.
In light of the COVID-19 pandemic, the RAC Board has elected to offer online testing with live online proctoring this summer.
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RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
The RAPS store will be under maintenance Saturday, 13 June 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.
Posted 16 April 2020 | By Zachary Brousseau
RAPS announced the official launch of the RAPS Germany Chapter, bringing the worldwide total to 19 chapters and eight local networking groups.
Posted 03 February 2020 | By Zachary Brousseau
A record-high 362 regulatory professionals have passed the Regulatory Affairs Certification (RAC) exam during the most recent RAC exam period, RAPS announced today.
Posted 23 January 2020 | By Zachary Brousseau
The RAPS board of directors of officially began its 2020 term on 1 January. Don Boyer, a former top Health Canada official who is now a private regulatory consultant, is serving his second ye...
Posted 17 October 2019 | By Zachary Brousseau
RAPS has announced the official launch of the RAPS Colorado Chapter. Chapter leaders and other representatives attended RAPS’ recent Regulatory Convergence in Philadelphia, where they were wel...
Posted 24 September 2019 | By Zachary Brousseau
RAPS today honored the 2019 class of RAPS Fellows, a distinction bestowed upon seasoned regulatory leaders who have gone above and beyond to give back to the profession and share their experie...
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