How to Prepare for the RAC US Exam

Regulatory Affairs Certification (RAC) is a specific and the only certification for individuals in the profession of healthcare product regulation. There are four different certifications provided by the RAC, three of which focus on knowledge of regional regulations of US, Canada, and the European Union. The fourth RAC certification is general in scope. The certification system requires candidates to take a computer-based exam at designated locations around the world. Exams are conducted in a two-month period twice a year in April/May or October/November. Recertification is required every 3 years. RAC certification can improve your opportunities for career growth and salary enhancement.

• 1

  Acquire experience in US healthcare regulations. According to Regulatory Affairs Professional Society, RAC certification exam is intended for professionals with 3 to 5 years of regulatory industry experience.

• 2

  Know your certification program and course structure well. RAC (US) certification focuses on regulatory issues with regard to medical devices, pharmaceuticals, biotechnology and biologics in the U.S. Raps.org provides in-depth exam content outlines (in PDF format) to assist in study preparation.

  Be informed as to which regulations the upcoming RAC exam will focus on. For example, the RAC exams for April/May 2011 includes questions on regulations in effect from December 31, 2009.

• 3

  Prepare a study plan. Base the plan on your exam content, your existing knowledge and study methods. Allot sufficient time for reading, preparation and review.

• 4

  Locate RAC US study groups in your area and participate in them. Visit government agency websites for up-to-date information on regulatory laws. Study books that provide information on policies and regulations concerning drugs, medical devices and biologics, such as "The Fundamentals of Regulatory Affairs."

• 5

  Undergo practice exams to analyze your progress and identify areas for improvement. RAC practice exams are available for purchase at raps.org. These practice exams are designed to simulate real RAC exams in which you must answer 100 multiple-choice questions in two hours. Raps.org also provides an on-demand webcast for RAC and suggests various learning products to assist you in exam preparation.