Earning your Regulatory Affairs Certification (RAC) is a significant investment in your regulatory career. The RAC is the only professional credential specifically 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 four challenging RAC exams—the average pass rate is between 40% and 50%—and to pass, you will need to be well prepared.
No Substitute for Regulatory Experience
Each of the four RAC exams—US, EU, Canada and Global—is 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 need to 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 Guide and the content outline for the relevant version of the exam, which are free, downloadable resources every exam-taker should have.
Know the RAC Exam Format
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 RAC Candidate Guide:
- Recall questions ask for specific information, typically about regulations and guidance that are important aspects of the regulatory process. These questions may relate to any stage of product development and may relate to regulations specific for product types.
- Application questions require relating specific knowledge to a situation that may be encountered in the scope of practice of a regulatory professional.
- Analysis questions may be described as a small case or example requiring the candidate to read and assemble information in order to identify and evaluate various solutions.
Know the Exam Content
Know what’s on the exam you’re taking. The content outlines for all four exams are appended to the Candidate Guide, and each also can be downloaded individually from the RAC exam prep page on the RAPS website. Each content outline provides a high-level overview of areas covered by that particular exam. The outlines are divided into three or four subject domains, depending on the exam. 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 even indicate how many 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.
Personalize Your Preparation
How you prepare for the RAC exam largely will be dependent on your own regulatory experience and knowledge. The scope of each of the four RAC exams is extensive. Exam content encompasses all aspects of healthcare product regulations, standards and compliance over the entire product lifecycle for multiple product types—mainly, pharmaceuticals, medical devices and biologics. There are likely to be some areas with which you have little direct experience. For example, if you have significant experience with device requirements but little knowledge of drugs, or vice versa, you likely will have to devote more time getting up to speed on the product area outside your scope of work. Use the content outline to help you identify the areas you need to focus on most.
"Do a complete and honest self-assessment to understand where you should focus your time and prioritize your efforts," advises Erin Oliver, RAC, head of US regulatory affairs for GlaxoSmithKline Consumer Healthcare. "Few of us are experts in every aspect of regulatory affairs and even a seasoned regulatory professional probably needs to brush up on some details. So, create a targeted, personalized study plan that fits your particular needs."
Identify Your Study Tools and Resources
There are many resources available—both free and for a fee—to help you prepare for whichever RAC exam you plan to take. In addition to the Candidate Guide and content outlines, free study checklists for all four exams are available on RAPS’ RAC exam prep page.
Practice Exams and Simulations
Also on the prep page are links to practice exams and exam simulations—each available for a fee—that can help you get a better feel for the exams and questions. The practice exams and simulations both are designed to help familiarize you with the content and types of questions on the exams, and to provide feedback on your areas of strength and weakness, but they are different from one another in some important ways. You may choose to use one or the other, or both in your preparation.
The practice exams are longer, featuring 100 multiple-choice questions drawn from a larger pool, and can be taken as many times as you want for a full year. Each time taken, the practice exam will serve up a different combination of questions and will generate a new coaching report that allows you to track progress over time.
The exam simulations are shorter, comprising 35 questions, and are conducted in the actual testing environment used for the real exams. They will provide the best “dress rehearsal” for the exam-taking experience and allow you to familiarize yourself with the exam software platform. They also will provide a report on your results, but unlike the practice exams, once your answers have been submitted, you will not be allowed to go through the simulation again.
Fundamentals of Regulatory Affairs
Although the Fundamentals of Regulatory Affairs series of books, which can be purchased in print or e-book versions from the RAPS Store, 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.
RAC Prep Toolboxes
If you are taking either the US or EU exam, RAPS’ RAC Prep Toolboxes offer ‘all in one’ study packages that include nearly everything you might need to prepare for the exams. Each of the two versions of the toolbox contains an extensive compilation of resources and tools, including content from the Fundamentals books, practice exams, interactive content and more than 25 hours of e-learning material. They are designed to help guide you in putting together your own customized study plan and following through with it. If the toolboxes are more than you need or you are preparing for one of the other exams, you should explore all the exam-specific study resources and packages available from RAPS.
A relatively new option for those studying for the US exam is RAPS’ RAC (US) Preparation Virtual Program. It is an eight-week online training course that is a mix of self-paced, on-demand webcasts and live Q&A sessions with regulatory experts who can answer questions, clarify concepts and elaborate on specific areas as needed, as well as access to an online community for virtual study groups. The cost of the program also includes the US practice exam.
Of course, you don’t have to participate in the virtual program to join a study group or start your own—virtual or face-to-face. RAC study groups have existed nearly as long as the exam itself, 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 who you are accountable to can help keep you on track and studying regularly.
RAPS chapters and local networks often have RAC 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. Anyone can form a study group. If being part of a group that meets in person is not an option, you can still connect online with others who also are preparing for the same exam. RAPS’ online community, Regulatory Exchange, Is a good place to look for others interested in forming a group.
Seek the Wisdom of Experience
No one knows better how to successfully prepare for an RAC exam than those who have done it. If you know any RAC holders, 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.
Invest the Time
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?