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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.
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.
No. When the RAC Board designed the RAC Drugs and RAC devices they wanted to give candidate the challenge of understanding international regulations but felt that if questions were pulled from too broad a field it would make the exams too difficult for candidates to study for, and beyond the likely need of most regulatory professionals with 3-5 years of experience. As such the scope of the exams was limited to US, EU and a handful of global bodies that are considered universally applicable. Questions regarding specific countries outside the jurisdictions noted above are not part of the RAC exam. For a full specification on the content and scope of the exam please see the exam sections and content.
No, currently there is not a specific RAC textbook. However, the Fundamentals books do include information that significantly overlaps with the content of the exam. While it is not designed as a text book for the RAC exam and is instead a desk reference for the regulatory profession a many RAC applicants do you use it as a tool for study towards RAC certification. Please also note that the Fundamentals books currently includes a chapter on Canada regulations, but those regulations are not part of the RAC Drugs or RAC Devices exams.
The RAC Program states or implies that preparation material provided by RAPS is the best or only means of adequately preparing for the RAC examination. No advantage is given to candidates who purchase or use RAC preparation material provided by RAPS over candidates who prepare using other materials and/or methods. The use and purchase of preparation courses and materials from RAPS is optional.
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 2021 (Spring, Summer and Autumn) are based on regulations EFFECTIVE on December 31, 2020. This would mean both MDD and MDR are eligible to be on the exam.
The RAC Exam is presently offered in English. There are no plans to offer the exam in other languages at this time, though that may change in the future.