About Regulatory Affairs Certification (RAC)

Regulatory Affairs Certification, known as the RAC, is the only certification specifically for regulatory professionals in the healthcare product sector. The RAC credential is a professional distinction that denotes commitment to excellence, pursuit of knowledge and career advancement. RAC-credentialed professionals are among the current and rising leaders in the regulatory profession. They work in all parts of the world and in many settings, including industry, government and academic organizations. To date, more than 5,000 individuals have earned the RAC.

Four different certifications are available:

• RAC (US): knowledge of US regulations
• RAC (EU): knowledge of European Union regulations
• RAC (CAN): knowledge of Canadian regulations
• RAC General Scope (GS): knowledge and critical thinking skills related to the general scope of practice of regulatory professionals throughout the product lifecycle, with reference to global standards from ICH, GHTF, WHO and ISO.

» Download The Four RAC Credentials - An Overview (PDF)


NEW - RAC General Scope (GS)

The RAC General Scope (GS) is a new certification available beginning with the October/November 2009 exam cycle. The RAC (GS) denotes knowledge related to the general scope of practice of regulatory professionals, regardless of where in the world they work or in which regions they may be involved.

» Learn more about the RAC (GS) exam and preparation


Why Get RAC-Certified?

Certification sets RAC-certified regulatory professionals apart, increases their value to employers and attests to their expertise and credibility. Attaining the RAC is a public recognition of professional achievement—to those both within and outside the profession. The RAC provides a means to measure and validate regulatory knowledge. It also can serve as step toward further career advancement, and in some cases, increased compensation. RAPS research has shown RAC certification correlates to higher compensation for professionals in entry- to mid-level positions and the proportion of RAC-credentialed professionals increases steadily at higher levels.


How to Get RAC-Certified

Candidates for the RAC take one of the four certification examinations (US, EU, CAN, or GS). The exams are computer-based and administered at multiple locations throughout the world during semi-annual, two-month testing periods: April/May and October/November. The regional exams address laws, regulations, policies and guidelines affecting regulated healthcare products, including medical devices, pharmaceuticals, biologics and biotechnology in their respective regions. The GS exam tests knowledge of regulatory practice and international standards as well as critical thinking skills. Each exam consists of 100 multiple-choice questions in English and has a two-hour time limit. The exams are reviewed and revised annually. To apply to take the RAC exam, visit the application information page.

An RAC Candidate Guide is available and includes information about applying to take the RAC exam, exam scoring, scheduling, eligibility requirements, test center rules and other important policies.

» Download the RAC Candidate Guide (PDF)


Preparing to Take an RAC Exam

RAPS offers a number of resources to help you prepare for each of the RAC exams, including content outlines, self-assessment exams, online courses and publications. To learn more about available resources, visit our RAC Exam Prep page.


What is the difference between a certificate and certification?

There's a lot of confusion about what a certificate program is and is not. The word "certificate" is used broadly as a document awarded to designate the attainment or completion of something. An individual might receive a certificate from an education or training provider as verification of attendance or participation in a learning event (often called a certificate of attendance or certificate of participation). The distribution of a certificate, however, does not indicate that the education or training program completed was a "certificate program." In a certificate program, an individual participates in a learning event or series of events designed to assist him or her in achieving specified learning outcomes within a defined scope, and the individual receives a certificate only after verification of successful completion of all program requirements (including but not limited to an evaluation of learner attainment of intended learning outcomes). If you are having a hard time envisioning what a certificate program is, think of the many certificate programs currently offered by colleges and universities.

It is also important to distinguish certificate programs from the certification of individuals. A professional certification, which may also be called a professional credential requires that an organization grants a credential to an individual after verifying that he or she has met established criteria for proficiency or competency, usually through an eligibility application and assessment. While certification eligibility criteria may specify a certain type or amount of education or training, the learning event(s) are not typically provided by the certifying body. Instead, the certifying body, through an application process, verifies education, training, and experience obtained elsewhere and administers a standardized test of current proficiency or competency. Development of a professional certification or credential takes several years of work involving subject matter experts and experts in testing and measurement. There are strict requirements and standards for credentially organizations to follow in developing and managing these programs.

In contrast, in a certificate program, the learning event(s) and the assessment(s) are both developed and administered by the certificate issuer, and there is an essential link between them. That is, the learning event(s) are designed to help participants achieve learning outcomes and the assessment is designed to evaluate the learners' attainment of those intended learning outcomes.

Also, certifications have ongoing requirements for maintaining proficiency or competency and can be revoked for not meeting these ongoing requirements. In contrast, certificates do not have ongoing maintenance or renewal requirements and, therefore, cannot be revoked.

Both certification and certificate programs issue designations and associated acronyms; however, it is essential that any designations issued for certificate programs do not state or imply that the individuals are certified.

FAQ

If you are unable to find the answer to your question about the RAC in these pages, visit the RAC Frequently Asked Questions section in the RAPS Solutions Center.