You have decided to pursue your Regulatory Affairs Certification (RAC). Good for you! The RAC is an excellent investment in your regulatory career. To earn the RAC you will have to pass one of four particularly challenging RAC exams. The average pass rate is between 40% and 50%. You are going to need to prepare.
Editor’s note: if you are still undecided about the RAC, you may want to start by reading Is Regulatory Affairs Certification Right for You? If you need help deciding which of the RAC credentials to pursue, read The Four RAC Credentials Explained. If you are unsure whether you meet the exam requirements, read RAC Eligibility Explained.
No Substitute for Regulatory Experience
All four RAC exams—US, EU, Canada and Global—are designed for professionals with three to five years of regulatory experience, and having that real-world know-how is a tremendous asset when preparing for and taking the exams. The exams include many questions that require you not only to know the relevant regulations, but also how to apply them in specific situations. “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.
While there is no substitute for experience, even a seasoned regulatory expert will have to devote significant time to preparing for the exam, and will need a study plan. The first step toward developing your study plan is to know exactly what is covered by the RAC exam you have chosen, as well as the exam format.
Know the RAC Exam Format
The RAC exams are computer-based and consist of 100 multiple choice questions that must be completed within two hours. There are three types of questions on the exams: recall, application and analysis.
According to RAPS’ RAC Candidate Guide:
- Recall questions ask for specific information, typically about regulations and guidances 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.
To get a sense of the different question types, you should watch part one of RAPS’ free three-part webcast series on preparing for the RAC exams, which also is embedded below.
Know the Exam Content
What’s on the exam? Free content outlines for all four exams are available online. You can find links to each individual content outline on RAPS’ RAC exam preparation page, as well as in the appendices of the RAC Candidate Guide and linked below.
Each content outline is divided into three or four subject domains, depending on the exam. The outlines even tell you how many questions to expect within each domain. It is important to remember all exams are updated annually and 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 the four RAC exams is extensive. Exam content encompasses all aspects of healthcare product regulation over the entire product lifecycle.
All exams cover regulations and standards that apply to multiple product types, including 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.
"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."
For more on developing an RAC study plan, see part two of RAPS’ free three-part webcast series on preparing for the RAC exams, which also is embedded below.
There are many free and paid resources available to help you prepare for whichever RAC exam you plan to take. In addition to the free, on-demand RAC exam preparation webcast and content outlines, there are a number of other resources linked from RAPS’ RAC preparation page. Some useful RAC resources include study checklists for each exam; 100-question practice exams for the RAC (US), RAC (EU) and RAC (Global), which provide feedback by content area and question; 35-question RAC exam simulations for each of the four tests, which help you get a sense of the testing environment; the Fundamentals of Regulatory Affairs series of books available from the RAPS Store; and RAPS’ new RAC Prep Toolbox, which brings together some of the above resources, plus interactive content in an e-learning environment to help you put together your own customized study plan and follow through with it and RAPS’ new RAC Prep Toolbox (currently available for the US exam), which brings together some of the above resources, plus interactive content in an e-learning environment to help you put together your own customized study plan and follow through with it. The RAPS store also offers a number of exam-specific study resources and packages.
Although the Fundamentals books are not designed specifically to serve as RAC exam study tools, they are often cited as important study aids. “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), manager of regulatory affairs with Johnson & Johnson Medical India.
Study groups can be another helpful resource for those who have access to one. 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. Some companies and many local RAPS chapters have their own RAC study groups, so find out if you have a chapter near you and contact chapter leaders to ask whether it has or is planning a study group. If there is no RAPS chapter nearby, you may still connect with others who also are preparing for the exam through the RAPS LinkedIn group or RAPS’ member-only online community, Regulatory Exchange.
This article originally published 17 February 2015, updated 18 August 2015
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