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The RAC (US) certification is a professional credential issued by the Regulatory Affairs Professionals Society (RAPS) that demonstrates expertise in U.S. regulatory affairs, particularly for pharmaceuticals, biologics, medical devices, and other healthcare products.
While there are no formal requirements, candidates are typically recommended to have 3 to 5 years of regulatory affairs experience and a bachelor’s degree.
The RAC (US) exam covers regulatory processes for pharmaceuticals, biologics, medical devices, and other healthcare products governed by the U.S. FDA.
The RAC (US) exam consists of 100 multiple-choice questions.
You are given 2 hours to complete the exam.
The exam covers four main areas:
The exam fee is $550 for RAPS members and $650 for non-members.
The RAC (US) exam is offered during specific testing windows, typically in the spring and fall each year.
The exam is administered at computer-based testing centers globally.
The exam focuses on the U.S. Food and Drug Administration (FDA) and its regulatory oversight of healthcare products.
The RAC (US) exam is computer-based and features multiple-choice questions with one correct answer.
Regulatory Affairs Certification (RAC) Global Scope
Regulatory Affairs Certification (Drugs)
TESTED 22 Dec 2024
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