RAC Exam

RAC Drugs Examination Autumn 2023

0.0 RAC Credits Member: $495.00 Nonmember: $625.00

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Application Deadline: 5 October 2023(11:59 PM EDT) 

Knowledge Required and Regulatory Basis:

• 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 guidances 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.

Best Suited For:

Pharmaceutical and biotechnology regulatory professionals with 3+ years of experience. Experience should include hands-on regulatory activities, knowledge of interaction with regulatory authorities, and appreciation of regulatory involvement throughout the entire product development and lifecycle.

Notice:

Please verify that the email address in your RAPS account is correct. At that email address, you will receive your notification to schedule (NTS) email from our testing vendor, SCANTRON. The NTS email provides login information necessary to access the SCANTRON website, where you will request your preferred exam date, time and location.