Exam Sections and Content

Each exam is based on a survey of the scope of practice and specific roles and responsibilities of regulatory professionals in the workplace with at least three years of regulatory experience. The specific content of each examination includes performance domains, tasks, and associated knowledge and skills and is based on a job analysis, statistical/psychometric analyses guided by subject matter and testing experts. The questions on the RAC exams are updated every year to reflect current regulations, guidelines and practice. Each year's RAC exams are based on regulations ‘on the books’ on December 31 of the prior year. 

Knowledge Required and Regulatory Basis

RAC DEVICES

• Knowledge of the full product development and lifecycle requirements for medical devices, and IVDs.
• Knowledge of US FDA requirements (30%); European regulations and guidance from the European Commission and competent authorities (30%); and globally applicable regulatory practices* (40%). (*IMDRF, WHO and ISO guidelines and standards).
• Critical thinking and analytical skills.
• Important note: there are no Canada-specific questions on the RAC Devices exam.

RAC DRUGS

• Knowledge of the full product development and lifecycle for pharmaceutical and medicinal and related products, APIs, biologics and biotechnology products.
•  Knowledge of US FDA requirements (30%); European regulations and guidance from the European Commission, EMA, and competent authorities (30%); and globally applicable regulatory practices* (40%). (*ICH and WHO guidelines and standards).
• Critical thinking and analytical skills.
• Important note: there are no Canada-specific questions on the RAC Drugs exam.

Question Types

The examinations consist of 100 multiple-choice questions, answered in a two-hour time limit. All RAC questions and content are written in English.

There are three question formats which may be used in the RAC Exams:

1. 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.
2. Application questions require relating specific knowledge to a situation that may be encountered in the scope of practice of a regulatory professional.
3. 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.

What the Exams Cover

While the examination content outlines may be used for a period of several years, the questions on the examinations are updated every year to reflect current regulations, guidelines and practice. New examination content is added for the Spring testing cycle and covers regulations in effect as of 31 December of the previous year.
 

RAC Exam Content Outlines

Please see the Content Outlines located in the RAC Exam Candidate Guides:

RAC Devices candidate guide »

RAC Drugs candidate guide »