Is the RAC right for me?
Applying for the RAC
Preparing for the RAC
Exam Day
Scoring
Maintaining your RAC
What are the RAC (US), RAC (EU), and RAC (CAN) Examinations?
The RAC (US) Examination is geared toward the RA professional with 3–5 years of regulatory experience and is based on US regulatory issues in the areas of pharmaceuticals, medical devices, biologics and biotechnology.
The RAC (EU) Examination is geared toward the RA professional with 3–5 years of experience in European regulations.
The RAC (CAN) Examination is geared toward the RA professional with 3-5 years of Canadian regulatory experience.
Find more information about the RAC and whether it's right for you.
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Do I qualify to take this examination?
The requirements to take the exam are that candidates have either a minimum of 3 years regulatory experience or a Bachelor's Degree (or its equivalent). Both experience and a Bachelor's degree are not required. Please note that the exam is intended for the RA professional with 3-5 years of regulatory experience.
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Can I take more than one exam during the two-month testing window?
Yes, you can take more than one RAC exam during the testing window. If you would like to take both the US and Canadian RAC exams, for example, you may. You need to submit a separate application for each RAC exam you would like to take. You may not take the same regional exam multiple times in the same testing window—for example, you may not register to take the RAC (US) twice.
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When are applications due for the next RAC (US), RAC (EU) & RAC (CAN) Examinations?
Applications for the October/November 2008 exam must be postmarked no later that 15 August 2008 for early registration and 8 September 2008 for late registration.
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How often is the RAC Examination administered?
The RAC (US), RAC (EU) and RAC (CAN) Examinations are administered twice a year, during two two-month testing windows: April/May and October/November.
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How should I submit my application?
You may submit your application online or via fax or mail. If submitting via mail, candidates are urged to use a return receipt delivery method (e.g., Federal Express, Priority Mail, etc.). If you do not receive a response from the RAC Program Office regarding your application within two weeks after submission, you are urged to contact the program administrator for confirmation of receipt. If you are submitting your application close to the 8 September 2008 for the October/November exam, do not wait two weeks to confirm receipt. Applications will NOT be accepted if postmarked or sent in after 8 September 2008 for the October/November exam.
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When will I be notified if my application is accepted?
Confirmation is within two weeks of receipt. However, if you do not receive confirmation of receipt you are urged to contact the RAC program administrator for confirmation. Due dates will not be changed for applications which are lost in the mail or not received via fax.
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All approved exam registrants will receive an email from our testing vendor with a user name and password and a link to their website exam registration page. This information is required for exam registration.
- All October/November 2008 registrants will receive their user names and passwords on 17 September 2008.
The testing centers release available dates 60 days in advance. If you prefer a date close to the end of the testing window, please keep this in mind.
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What is the fee for taking the RAC Examination?
RAPS members—first-time applicants early registration $325 USD
RAPS members—first-time applicants late registration $375 USD
RAPS members—reapplication fee early registration $225 USD
RAPS members—reapplication fee late registration $275 USD
RAPS nonmembers—first time applicants early registration $510 USD
RAPS nonmembers—first time applicants late registration $560 USD
RAPS nonmembers—reapplication fee early registration $410 USD
RAPS nonmembers—reapplication fee late registration $460 USD
There is no limit on the number of times you may sit for the examination.
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Do you have to be a member of the Regulatory Affairs Professionals Society (RAPS) to take the RAC Examination?
No. However, RAPS members receive discounts on programs and study materials offered by RAPS. If you do not maintain membership and you obtain the RAC designation, you must remember to notify RAPS of any change in address or email information if you wish to receive reminders regarding your recertification deadline.
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What is the cancellation/withdrawal/transfer policy?
Candidates who submit written notification of their intent to withdraw from the examination must do so no later than the late registration deadline and will receive a refund minus a $100 non-refundable processing fee. The late registration deadline for the October/November 2008 exam is 8 September 2008. Candidates who do not submit written notification by the late registration deadline will not receive a refund.
Candidates may transfer to the next testing window (i.e., October/November 2008 may transfer to April/May 2009) but must pay the reapplication fee. One transfer is permitted, and the request must be received by the late deadline date.
Candidates who provide documentation of a serious medical emergency or death of an immediate family member may transfer to the next testing window. Appropriate documentation must be received at the RAC Program office within sixty (60) days after the RAC Examination date. A fee of $79 applies to reschedule.
Refunds and transfers are not permitted after the late deadline date.
The April/May transfer deadline was 10 March 2008.
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Whom do I contact to confirm receipt of my application or to obtain additional information?
Contact RAC Program Office, 5635 Fishers Lane, Suite 550, Rockville, MD 20852; phone: 301.770.2920 ext. 200. You may also email us at certification@raps.org.
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When do I receive my exam registration information?
All Spring 2008 candidates will receive their exam registration e-mail on 14 March 2008. Please note that this e-mail will come from castleworldwide.com, not a raps.org e-mail address.
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How should I prepare for the RAC Examination?
There are no prescribed study methods or approaches. You should develop a study plan that takes into account your knowledge and experience, your schedule and your learning/study preferences. The RAC Content Outlines, found in the RAC Candidate Guide and linked from our Reference Tools web page, will help guide your studies. It is very important to allow yourself adequate time to read, review and prepare. You may also find it helpful to develop a plan using a combination of learning methods such as focused meetings or conferences, intense preparation courses, participation in local study groups or other peer learning methods, reading technical and professional literature, and using study aids such as the Fundamentals of Regulatory Affairs and Self-Assessment Examination (SAE). A wide range of publications and programs are available through RAPS for exam preparation.
RAPS also offers Webcasts that are preparation courses for the RAC twice a year. Please check the RAPS Website (www.raps.org/webcasts) for more details.
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What materials should I read/review?
Begin by reading the RAC Candidate Guide and Application (135kb, PDF) so you become familiar with the RAC Program's policies and procedures. The RAC Content Outline for each exam, included in the Candidate Guide and also linked off the Reference Tools web page, will help you develop a study strategy. Laws, regulations, guidances and other documents are available from government agency websites.
The Fundamentals of Regulatory Affairs book series, available through RAPS, offers a comprehensive overview of terms, regulations, policies and key perspectives related to drugs, devices, biologics and other elements in specific regulatory systems to help round out your regulatory knowledge. Other reference materials, including RA Acronyms & Definitions Pocket Guides for US, EU and Canada, and US Regulatory References on CD-Rom are also available from RAPS. Finally, you may find it useful to purchase an RAC (CAN), RAC (EU),or RAC (US) Self Assessment Examination (SAE), which will allow you to take practice exams and assess areas where additional concentration may be needed. All products may be ordered online through RAPS Bookstore. Updated versions of Fundamentals of US Regulatory Affairs and Fundamentals of EU Regulatory Affairs are available.
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Are practice or "old" exams available?
Previous versions of the exam are not available. The SAE is a practice exam that also includes guidance to help you in planning your study. The SAE was developed independently of the actual RAC Examination. It is based on the job analysis survey data used to develop the exam. Every attempt is made to develop questions similar to those on the exam.
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What regulations will be on the RAC Examination?
The October/November 2008 (CAN, EU & US) Examinations include questions on those laws and regulations in effect as of 31 December 2007. Refer to the RAC Candidate Guide or the Reference Tools webpage for each exam's Content Outline.
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How many questions are on the RAC Examinations?
There are 100 multiple-choice questions on each exam.
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How many RACs are there?
Over 4,000 individuals have earned the RAC designation. RAPS launched this voluntary certification in 1990. Guided by the Regulatory Affairs Certification Board (RACB), the certification program is designed to elevate professional standards, distinguish individuals demonstrating knowledge essential to regulatory affairs and enhance individual performance.
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Where are the RAC Examinations administered?
Our independent testing company has exam sites all over the US and Canada as well as international locations. Please click here to view the current list of exam locations. You may take any of the RAC exams—RAC (US), RAC (EU) or RAC (CAN)—in any of the established sites. If none of the sites on the list is convenient to your location, there is an option to suggest a new site location, when registering for the exam date. The testing company will let you know if they are able to set up a site in your requested location.
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At what times do the RAC Examinations begin?
With the move to computer-based testing, you get to schedule the date, time and location that are most convenient for you.
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Will I need to make travel arrangements to take the RAC Examination?
You are responsible for your own travel and lodging arrangements if necessary.
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What do I need to bring with me to the test site?
You must bring a photo ID. You should also bring your confirmation notice.
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How is the passing score determined?
The exam is scored by an independent testing agency. The results are then reviewed by specialists in testing and measurement (psychometricians) in conjunction with the RAC Examination Committee. These experts review the overall results on the current exam as well as the responses to each question. These are then used to develop a "scaled score" that takes into consideration the degree of difficulty of questions and exam/question performance. The scaled score is calculated from the raw score (your actual number of correct answers combined with a weighting factor). For the RAC Examination, a scaled score of 75 is the minimum pass score. The same type of approach is used for many professional licensure and certification exams as well as for most standardized tests.
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When will I receive information on my exam score?
You will receive written notification of your exam score and passing status approximately 3-4 weeks after the exam window closes. Information will not be given out over the telephone or via fax. Your exam score is kept strictly confidential; no information is released on individuals who do not pass the exam. A listing of all new RACs will appear on the RAPS website at www.raps.org/rac approximately 2-3 weeks after letters have been mailed to test takers.
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What happens when I pass the RAC Examination?
Several events will take place shortly after you receive notice of your status as a new RAC (US), RAC (EU) or RAC (CAN). In recognition of your professional status, you will receive a personal certificate and a lapel pin with the RAC insignia. A listing of new RACs is published in RAPS' monthly magazine, Regulatory Affairs Focus, within a few months after notifications are distributed. A listing of all new RACs appears on the RAPS website at www.raps.org/rac. You will be able to use the professional designation of RAC after your name on your business cards and in professional communications.
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Do RACs have to recertify?
Yes. To retain the RAC (US), RAC (EU) or RAC (CAN) certification, a Regulatory Affairs professional must accumulate a minimum of 60 professional points every three years and submit an RAC Recertification Report to the RAC Program Office. Professional points can be accumulated through a wide range of professional activities, including attending educational meetings and conferences, speaking, writing and participating in professional organizations. RAC recertification is flexible to accommodate diverse learning styles and approaches to professional involvement. At least 40 points must be accumulated in activities directly related to regulatory affairs. There is a recertification fee of $75 (member cost) or $260 (nonmember cost). For more detailed information you may obtain a Recertification Guide from the Recertification page of this site. Individuals who have two or more RAC designations (US and/or EU and/or CAN) need only recertify one time to maintain all designations.
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