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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS' Latest | 18 March 2021 | By Zachary Brousseau
Earning your Regulatory Affairs Certification (RAC) is a significant investment in your regulatory career. The RAC is the leading credential for regulatory professionals in the healthcare product sector. It shows employers, clients, colleagues and others not only that you have the requisite regulatory knowledge, but also that you are committed to your profession. To get the credential, you must pass one of two challenging RAC exams. The average pass rate is between 40% and 50%. To pass, you will need to be well-prepared.
Both RAC exams—RAC Devices and RAC Drugs—are designed for professionals with three to five years of regulatory experience. They include many questions that require not only knowing the relevant regulations, but also how to apply them in specific situations.
The exams are designed to test more than just knowledge. You also must demonstrate the analytical and critical thinking skills needed in real-world situations, which is why one to three years of regulatory experience is required to be eligible to take the exams. “The exam is not just about content mastery. You need to have experience to choose viable and practical solutions to the case studies presented,” says Mark Kramer, RAC, president of Regulatory Strategies Inc. When it comes to being exam-ready, there simply is no substitute for experience.
This is not to suggest that exam takers can rely solely on their experience and expect to pass. Even a seasoned regulatory expert will have to devote time to study and preparation. The first step to developing your study plan is knowing exactly what is covered by the RAC exam you have chosen, as well as the exam format. This essential information can be found in the RAC Candidate Guides and the content outlines, which are free, downloadable resources every exam-taker should have.
The RAC exams are computer-based and consist of 100 multiple choice questions. They must be completed within two hours. There are three types of questions on the exams: recall, application and analysis. The three question types are described in the Candidate Guides:
Know what’s on the exam you’re taking. The content outlines are appended to the Candidate Guides or can be viewed online. Each content outline provides a high-level overview of areas covered by that particular exam. The outlines are divided into four subject domains. Each domain is further divided into sub-topics and competency statements describing in broad terms, typical responsibilities regulatory professionals would be expected to perform or oversee. The outlines also indicate the percentage of exam questions to expect within each domain. It is important to remember all exams are updated annually and questions refer to regulations in effect as of 31 December of the previous year.
How you prepare for the RAC exam depends on your own regulatory experience and knowledge. The scope of each exam is extensive. Exam content encompasses all aspects of healthcare product regulations, standards, and compliance over the entire product lifecycle for pharmaceuticals and biologics if taking the RAC Drugs exam, or for medical devices and IVDs if taking the RAC Devices exam. There are likely to be some areas with which you have little direct experience, and you may have to devote more time getting up to speed on aspects outside your scope of work. Use the content outline to help you identify the areas you need to focus on most.
There are many resources available to help you prepare. In addition to the Candidate Guides and content outlines, you will find books, online courses, and practice tests available for purchase individually or as part of RAC prep toolboxes and bundles, as well as free study checklists, on RAPS’ RAC Prep Tools page.
Note: RAPS is offering two upcoming RAC exam prep workshops, Preparing to Take the RAC Drugs Exam, 8–9 February, 2022, and Preparing to Take the RAC Devices Exam, 15–16 March, 2022.
Although the Fundamentals of Regulatory Affairs series of books, available in print or e-book versions, are not designed specifically to serve as RAC exam study tools, their comprehensive coverage of regulations and other important regulatory information make them important resources for many exam takers.
“RAPS’ books provided centralized knowledge and exhaustive references, which was a great help, not only from the exam perspective. The Fundamentals of Regulatory Affairs book is a great and essential reference material for RA professionals,” says Sharad M. Shukla, RAC (US, EU), associate director of regulatory affairs with Johnson & Johnson Medical India.
Study groups, typically held virtually these days, are another great resource for RAC candidates, and many who have earned the credential participated in one as part of their preparations. Shukla says joining a study group helped him better understand concepts that were outside his core expertise. It gave him the opportunity to engage in discussion with peers who had experience in those areas he did not. Study groups can also help boost your motivation. Having people other than yourself to whom you are accountable can help keep you on track and studying regularly.
Connect with other exam takers through the RAC Community on RAPS’ Regulatory Exchange. RAPS chapters and local networks may also offer study groups. If there is a chapter or network near you, check with chapter leaders or ask other members. Some groups are chapter sponsored while others may be more informal. Sometimes, study groups are started by a group of employees at the same company—usually at larger companies with sizeable regulatory teams.
No one knows better how to successfully prepare for an RAC exam than those who have done it. If you know anyone who has earned the RAC, ask them about their preparation, including what they found most helpful and what they might have done differently with the benefit of hindsight. Speak with as many of them as you can. You’re sure to hear different tips or pitfalls from different people. And keep in mind that something that was helpful to others may or may not work for you. You will have to judge how the methods used by others fit with your own learning style, schedule, etc.
No matter how much experience you have or what resources or methods you use to prepare for the RAC exam, there is no getting around the fact it takes time to study. This may be one of greatest challenges for busy regulatory professionals, but the more time you can devote to preparation, the better you are likely to do on the exam. Although this simple fact is straightforward, acting on it takes dedication. But isn’t your dedication to regulatory affairs why you are pursuing the RAC credential in the first place?
Tags: Affairs, Certification, exam, preparation, RAC, Regulatory