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| Certification Vendor: | Regulatory Affairs Professionals Society (RAPS) |
|---|---|
| Exam Name: | Regulatory Affairs Certification (RAC) Global Scope Exam |
| Exam Number: | RAC-GS |
| Related Certifications: | RAC-Drugs RAC-Devices |
| Exam Duration: | 210 minutes |
| Exam Format: | Analysis, Multiple Choice, Recall, Application, Computer-Based |
| Exam Price: | $605 (RAPS Member), $760 (Non-Member) - 2026 rates |
| Certificate Validity Period: | 3 years |
| Available Languages: | English |
| Real Exam Qty: | 150-180 |
| Passing Score: | 70% |
| Recommended Training: | RAPS Fundamentals Textbooks RAPS Online University |
| Exam Registration: | RAPS Official Application Pearson VUE Scheduling |
| Sample Questions: | ![]() |
| Exam Way: | Computer-based testing at Pearson VUE centers or online remote proctoring |
| Pre Condition: | Bachelor's degree + 3 years regulatory experience; Master's + 2 years; Doctorate + 1 year; RAPS membership recommended |
| Official Syllabus URL: | https://www.raps.org/certifications/rac |
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Regulatory Submissions & Approval | 20% | - Review Process & Interactions
|
| Topic 2: Global Regulatory Environment & Strategy | 35% | - Regulatory Strategy & Planning
|
| Topic 3: Post-Market Compliance & Surveillance | 20% | - Pharmacovigilance & Adverse Events
|
| Topic 4: Product Development & Lifecycle Management | 25% | - Clinical Research & Trials
|
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According to the latest exam information, the RAC-GS exam contains 150-180 questions within 210 minutes minutes. The testing engine reproduces that scope and calculates your final practice score — a useful reference for judging real-exam readiness.
At present, the RAC-GS exam requires a passing score of 70%, with a registration fee of $605 (RAPS Member), $760 (Non-Member) - 2026 rates. RAPS sets both figures and may revise them, so confirm on the official site before you schedule.
The RAPS Regulatory Affairs Certification (RAC) Global Scope blueprint covers these core domains:
Further domains complete the official outline; the question bank addresses all of them.
With data, not guesswork. The RAC-GS testing engine is user-friendly and easy to install; upon completion of each practice test, it calculates your final score, giving you a concrete reference for the real exam. Behind the tools, professionals and IT specialists compose the materials, and every answer is expert-verified — aligned with the real exam's format across the RAPS Regulatory Affairs Certification (RAC) Global Scope objectives. Before buying, try the free demo questions to test your knowledge; after buying, 24/7 Customer Service and Live Support assist with any problem, and you can ask the team for a discount code. That is the remarkable experience we work to provide.
RAPS states the following prerequisites for the RAPS Regulatory Affairs Certification (RAC) Global Scope: Bachelor's degree + 3 years regulatory experience; Master's + 2 years; Doctorate + 1 year; RAPS membership recommended.
Check the authoritative wording on the official certification page before booking.
Which of the following is MOST appropriate for the purpose of lot release of biologics?
Correct Answer: A 🗳️
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?
Correct Answer: C 🗳️
A company's product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?
Correct Answer: C 🗳️
Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?
Correct Answer: D 🗳️
Which of the following situations does NOT require rapid communication to regulatory authorities?
Correct Answer: A,B 🗳️
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