RAPS Regulatory Affairs Certification (RAC) Global Scope RAC-GS Prüfungsfragen mit Lösungen:
1. When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
A) Phase III clinical trials
B) Phase I and II clinical trials
C) Pre-clinical studies
D) Phase I clinical trials
2. A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?
A) Early collaboration
B) Follow-up meeting after submission
C) Frequent communication
D) Documented agreement
3. In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?
A) Local reimbursement requirements
B) Training program for sales people
C) Service operation procedures
D) Written procedure for product traceability
4. Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
A) Subject is hospitalized for the purpose of product administration.
B) Subject is hospitalized due to complications of the product administration.
C) Subject's hospitalization is due to an unscheduled hip operation.
D) Subject's hospitalization is prolonged during the clinical trial.
5. According to WHO,what are the temperature and humidity conditions for a Zone IVb long-term stability study?
A) 30c C and 65% RH
B) 30c C and 35% RH
C) 30: C and 75% RH
D) 25: C and 60% RH
Fragen und Antworten:
| 1. Frage Antwort: A | 2. Frage Antwort: C | 3. Frage Antwort: B | 4. Frage Antwort: A,C | 5. Frage Antwort: C |
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