Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
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.
Convergence 2020 has come and gone, but you can still access recorded sessions, which are available to attendees until 31 December 2020.
This year, our European regulatory community will converge online with a fully virtual program that will allow attendees to experience Euro Convergence live online from the safety and comfort of their homes.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
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.
RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Posted 13 February 2018 | By Zachary Brousseau
RAPS is pleased to announce that 248 regulatory professionals passed the Regulatory Affairs Certification (RAC) exam during the autumn 2017 testing period, thereby earning the RAC credential.
The RAC is the only professional credential for regulatory professionals in the healthcare product sector. Certification must be maintained through continuous learning and professional development, and renewed every three years. Currently, there are more than 4,500 RAC-credentialed professionals worldwide.
“Congratulations to the latest successful class of applicants for the RAC credential, and to all current holders of the RAC,” said RAPS Executive Director Paul Brooks. “RAC-credentialed professionals not only demonstrate current knowledge of relevant regulations and the critical thinking skills to apply them in a variety of situations, but also have several years of practical RA experience and have committed to improvement of the regulatory affairs profession via continuous learning and growth.”
See below for the complete list of professionals who attained the RAC credential in autumn 2017.
There are four different RAC certifications available: the RAC (US) covering US regulations, the RAC (EU) covering European regulations, the RAC (CAN) covering Canadian regulations and the RAC (Global), which covers general regulatory responsibilities and international standards. RAC exams and the criteria for maintaining the credential are developed, managed and administered by the Regulatory Affairs Certification Board (RACB) with support from RAPS.
Regulatory Focus newsletters
All the biggest regulatory news and happenings.