RAC Study Group
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About the Regulatory Affairs Certification through the Regulatory Affairs Professionals Society (RAPS).
RAPS provides certification for the healthcare product RA community through its Regulatory Affairs Certification (RAC). The RAC designation is a mark of professional distinction. The RAC is indicative of the professional and technical abilities that are vital in this time of increasing challenges and demands within the health product sector.
Regulatory Affairs Certification (RAC) is a professional distinction that identifies individuals committed to excellence, the pursuit of knowledge and career advancement. The RAC is the only certification available to RA professionals within the healthcare product sector.
To become certified, individuals must pass the RAC examination, offered every year in April and November at worldwide locations. Three different certifications are available: RAC (CAN) for Canadian regulations, RAC (EU) for European regulations and RAC (US) for US regulations.
Currently, more than 3,000 RA professionals have earned the RAC designation, with many of them holding more than one regional credential (Canada, EU or US).
RAC-credentialed professionals are among the current and rising leaders in regulatory affairs in industry, government and academic organizations. It is intended for the regulatory affairs professional with three to five years of regulatory experience.
Why is Certification Desirable?
Certification sets those with the credential apart—or above—those without it. There are a number of advantages to seeking certification. Certification becomes a public recognition of professional achievement—both within and outside of the profession. For many, achieving certification becomes a personal professional goal—a way to test knowledge and to measure it against one’s peers. Others see certification as an aid to career advancement.
Exam Overview
100 multiple-choice questions for each of the RAC exams
Two hours to complete each exam
Administered by computer
Administered only in English
The RAC Examinations are knowledge-based examinations addressing laws, regulations, policies and guidelines affecting regulated health products, including medical devices, pharmaceuticals, biologics and biotechnology in their respective regions. The examination is reviewed and revised annually.
For a comprehensive description of the RAC examinations, including procedures, format and a content outline visit www.raps.org for more information.