What the RAC (General Scope) Exam Covers
The RAC (General Scope) exam is intended for regulatory professionals with 3–5 years of experience and is largely based upon knowledge and application of regulatory functions throughout the healthcare product lifecycle. It covers all product areas, including medical devices, IVDs, pharmaceuticals, medicinal products and biologics. Also covered on the exam are international standards and guidelines including those of ICH, GHTF, WHO and ISO. As with all RAC exams, critical thinking and analysis skills are important components of exam success.

The exam is divided into the following four major subject areas or domains:

• Strategic planning
• Premarketing
• Postmarketing
• Interfacing

Each domain encompasses 10–23 essential tasks regulatory professionals need to be familiar with. Please see the RAC (General Scope) Exam Content Outline for a full list of tasks and detail about the knowledge skills required for each.

The RAC (General Scope) Exam itself is comprised of 100 questions presented in a multiple-choice format. The RAC exam questions fall into three categories:

• 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. Approximately 25% of the exam questions will be recall.
• Application questions require relating specific knowledge to a situation that may be encountered in the scope of practice of a regulatory professional. Approximately 50% to 55% of RAC exam questions are considered application type questions.
• 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. Approximately 20-25% of the examination will contain analysis.

Who Should Take the RAC (General Scope) Exam
Regulatory professionals who are involved in international regulatory affairs, whose work focuses on geographic regions such as Asia, Latin America or emerging markets not covered by one of the three regional RAC exams or those who already hold two or more of the other RAC credentials may be potential candidates for the RAC (General Scope). See The Four RAC Credentials: An Overview for a comparison of the RAC (General Scope) and the other three RAC credentials.


Preparing for the RAC (General Scope) Exam
RAPS has put together the following preparation tips and suggested materials and references for RAC (General Scope) exam takers; however, there is no one study plan that is right for everyone and your experience will be a key factor in your performance on the exam. Your study preparation will depend largely upon your own areas of expertise and an honest assessment of your strengths and weaknesses relative to the exam outline. Above all, there is no substitute for regulatory experience.

Considerations for those who already hold another RAC credential:

• The key areas of this exam are similar to other RAC exams. Questions cover strategic planning throughout the product lifecycle, premarket steps and considerations (preclinical, clinical and product registration); and postmarket aspects (manufacturing, compliance, postmarket surveillance).
• The regulations included on the exam include GHTF (for devices), ICH (for drugs) and relevant WHO and ISO guidances. Many of these guidances are used for developing US, EU and Canadian regulations.

Considerations all RAC (General Scope) exam takers:

• Like other exams, the RAC (General Scope) exam is built upon the critical thinking that regulatory professionals must use in the course of their work.
• As stated above, the regulations included on the exam include GHTF (for devices), ICH (for drugs) and relevant WHO and ISO guidances.

Some initial steps to prepare for the RAC (General Scope) exam

• Assess your level of knowledge and experience and your current scope of responsibilities, including what types of products you have worked with and if your knowledge and experience extends throughout the product lifecycle. This will help you to determine the areas where you first need to further develop your knowledge base before moving to an applied level of understanding.
• Create a study plan. Begin with areas where you have less experience. It may be effective to begin with the products areas where you have less experience and then move to those where you are experienced. You should also examine steps within the lifecycle where you have less experience and include these early in your study preparation.

Materials and References for RAC (General Scope) Exam Preparation
While there currently is no all-in-one study guide or textbook for RAC (General Scope) exam preparation, RAPS has developed a few packages of materials and references to help exam takers fill in the gaps in their knowledge and prepare for the GS exam. A RAPS Webcast series specifically geared toward RAC (General Scope) preparation is scheduled to be available in September and other materials are currently in development, but it bears repeating that your own regulatory experience in the areas detailed in the RAC (General Scope) Exam Content Outline will be a critical factor in your exam preparation strategy.

For more on RAC (General Scope) exam preparation materials, visit the RAC (General Scope) Exam Reference Tools section of the RAPS Bookstore.