Passing the Regulatory Affairs Certification (RAC) exam can be a significant milestone in your regulatory career. The RAC is the only post-academic professional certification specifically for healthcare product regulatory professionals, and in the 22 years since it was first introduced, it has developed a reputation as a respected and important credential in the field.
Why Get the RAC?
While regulatory experience is almost certainly the most important factor employers, clients and regulators will look at in assessing your competence, having "RAC" after your name certainly doesn't hurt, and it signals that you have the essential knowledge and critical thinking skills required. RAPS' research also shows the credential is correlated with higher salaries, and many RAC-credentialed professionals will tell you the positive impact it has had on their careers.
Getting Ready for the Exam
Once you have decided to pursue the RAC, you will need to plan your exam preparation strategy. Just as there is no one unified career trajectory in regulatory, likewise there is no one right way to prepare for the RAC exam. Your preparation will largely depend on your regulatory experience, and on which of the four different RAC exams-US, EU, Canada or Global-you plan to take.
The Regulatory Affairs Professionals Society (RAPS) is offering three new RAC exam preparation webcast series-for the US, EU and Global exams. The first of these, the RAC (US) Exam Preparation Series-A Three-Part Series, begins 31 July 2013. The US series will cover medical devices, pharmaceuticals and biologics in three separate live webcasts.
The presenters for this series include Mark Kramer, president, Regulatory Strategies Inc., Fox Point, WI; Karen Metcalfe, RAC, associate director, regulatory affairs, DynPort Vaccine Company LLC, Frederick, MD; Erin Oliver, MS, MBA, RAC, director, regulatory affairs, GSK Consumer Healthcare, Parsippany, NJ; and Kathryn Riling, MS, RAC, regulatory affairs specialist, DynPort. Regulatory Focus recently asked Kramer, Metcalf, Oliver and Riling about how to prepare for the RAC (US) exam.
Experience Matters, But So Does Preparation
The RAC exams are experience-based and recommended for those with three-to-five years in the regulatory profession. "I think professional experience is a tremendous asset when preparing for the RAC exam. So much valuable knowledge is gained through professional experience that is not necessarily 'textbook' taught," says Riling, who attained her RAC in 2008.
However, if you are an experienced regulatory pro, don't assume you're all set to pass the exam. "Even a very experienced regulatory professional can't just show up for the exam without preparing for it and expect to do well," says Kramer, who also earned his RAC in 2008, after spending most of his career at the US Food and Drug Administration (FDA). "Initiate reading and studying several months before the exam," recommends Metcalfe, who earned her RAC in 2011. "There is a great deal of information to learn."
"Treat your RAC prep like the high-value project it is and use your strategic project management skills," says Oliver, who first earned her RAC (US) in 2005 and took the exam again in 2012. "Start early, have clear study objectives in mind, identify your resource needs and follow a thoughtful, methodical process."
Personalize Your Study Plan
Understanding where your own subject-area strengths and weaknesses lie is critical. "The exam covers material on a range of FDA-regulated products and over the total product lifecycle. Given the way our profession is typically specialized, it's unlikely that many people are fluent with all the RAC content in their day-to-day jobs," says Kramer.
"Do a complete and honest self-assessment to understand where you should focus your time and prioritize your efforts," advises Oliver. "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 Important Resources
There are a number of resources-both paid and free-that can be core pieces of your exam prep plan. "Sign up for RAPS' RAC exam preparation webcasts. Participate in a local RAC study group if available in your area, so you can share your knowledge and learn from others about regulatory requirements of a different product area. RAPS has practice exams available that help you check your understanding and get familiar with the type of questions. I made my own study notes based on the excellent content in the Fundamentals of US Regulatory Affairs book that I found very helpful," says Kramer.
Although RAPS' US Fundamentals book is not designed specifically as an RAC exam-prep tool, it is often cited as an important study aid. Riling also mentioned it as a resource. "Know and read the actual laws, regulations, and guidelines," she says. "At the beginning of each chapter in the Fundamentals book is a very comprehensive list of these related to specific topics covered within each chapter."
What the Webcast Will Cover
Anyone using US Fundamentals and the webcast series as part of their exam prep will find they complement one another well. According to Oliver, the US webcast series "builds on the [US Fundamentals] content with additional, real-world context, and provides an opportunity for participants to follow up through interactive Q&A sessions." Riling adds: "It is also very helpful to have the webcasts in a three-part series so that someone very familiar with medical devices has the opportunity to learn the regulatory requirements for pharmaceuticals and biologics, and vice versa."
Kramer's 31 July webcast presentation, with Bob Rogers of Invacare Corporation, Elyria, OH, will cover key features of US device regulation, including classification and reclassification, the "least burdensome" principle, use of consensus standards, pre-submissions, and the four main types of device premarket submissions: 510(k) clearance, Premarket Applications, Investigational Device Exemptions and Humanitarian Device Exemptions.
Oliver's 7 August presentation, with William (Trey) Putnam of Beckloff Associates, Overland Park, KS, will cover key considerations in the pharmaceutical development process, from pre-approval through submission and post-approval requirements, and it will highlight the critical role of the regulatory professional thoughout.
Metcalfe and Riling will present together on 14 August, covering the requirements for biologics submissions, compliance, labeling, advertising and promotion. Their presentation will draw heavily from material in the biologics section of US Fundamentals.
For more information or to register for this webcast series, visit RAC (US) Exam Preparation Series-A Three-Part Series.