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Certification
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) ia 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.
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.
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.
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Congratulations to the October/November 2008 class of RACs. View (pdf)
A full list of all individuals who currently have the RAC designation.All Current RACs (pdf)
Questions about the RAC? Please contact us at certification@raps.org.
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