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.
Replay the moments of Euro Convergence 2020. Recorded sessions are available to attendees until 31 January 2020.
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.
Your RAC credential highlights your ongoing commitment to regulatory excellence. However, after you complete the exam, you must maintain your credential through continued education and professional development activities and applying for recertification every three years.
RECERTIFICATION
The RAC program will publish a list of current RAC certificants on the RAC webpages. Any listing of RAC certificants will be limited to the individual’s name, country of residence and include which RAC designations the individual has earned. These listings will be available for verification of RAC certificants. Certificants may opt out of being included in this listing.
The listing of RAC certificants will be updated after completion of each exam administration cycle and after completion of each recertification cycle. Certificants who do not maintain recertification will not be listed.
CERTIFICANT LOOKUP
This is a decision that each individual must make for themselves. However, candidates may wish to consider where they see their future career heading, and how their prior experience may help them in passing the exam.
Preparation materials have been created by RAPS for the new exams. This includes practice exams, toolboxes, books, content outlines, checklists and more. For more details please see https://www.raps.org/rac-credential/prepare-for-the-exam.
Note: RAPS does not state or imply that RAC preparation material provided by RAPS is the best or only means for preparing adequately for the RAC examination. No advantage is given to candidates who participate in preparation material provided by RAPS, over candidates who choose to prepare using any other material or method. The use and purchase of preparation courses and materials is optional. RAPS and the RAC program does not state or imply that these education or training programs are the only or preferred route to certification.
The RAC (Devices) exam content includes knowledge of US FDA requirements (30%); European regulations and guidance from the European Commission and competent authorities (30%); and globally applicable regulatory practices* (40%). (*IMDRF, WHO and ISO guidelines). The RAC (Drugs) exam content includes knowledge of US FDA requirements (30%); European regulations and guidance from the European Commission, EMA, and competent authorities (30%); and globally applicable regulatory practices* (40%). (*ICH and WHO guidelines and standards).
Candidates may change their exam for no charge up until the application deadline for the window they are scheduled to test in. In 2020 the deadlines are as follows:
To make changes, the candidates must call the customer service team at (301) 770-2920 ext. 200. Candidates may not change their exam type after the deadline of the exam window. Candidates may change exam windows and pay a transfer fee.*
*In light of COVID-19, candidates who signed up to take the RAC Spring exams in 2020, RAPS will waive the transfer fee to the summer 2020 window. To make this change, please call the customer service team at (301) 770-2920 ext. 200.
The RAC credential eligibility requirements remain unchanged. As with all eligibility requirements for the RAC, any changes will need to be approved by the RAC Board. The questions in all RAC exams will be of the same level (reflecting 3-5 years of experience in the profession).
The regional exams were last offered in the autumn of 2019. Beginning in 2020, only the Drugs and the Devices exam will be offered to candidates.
RAC holders who took regional versions of the RAC can continue to maintain their RAC status for as long as they wish, as long as they continue to recertify. Whether an individual holds one of the regional exams, or passes one of the product sector RAC exams, RAC holders will be equally recognized by the RAC program, and will be eligible to put ‘RAC’ after their name.
Recent RAC program research showed that regulatory professionals tend to focus on a primary product area, and during the recent review of the RAC program, the need for the credential to more accurately reflect this reality became clear. To meet that need, The RAC program launched two sector-focused exams: the RAC Drugs and the RAC Devices.
The RAC board believes that these changes are to the benefit of the long-term strength of the program. For the RAC to remain a valued credential for current and future RAC holders, as well as for employers, we need to ensure that it grows and develops with the profession.
The RAC exams offered in 2020 (Spring, Summer and Autumn) are based on regulations ‘on the books’ on December 31, 2019. This would mean both MDD and MDR are eligible to be on the exam.