RAPS RAC-US 시험 개요:
| 인증 벤더: | Regulatory Affairs Professionals Society (RAPS) |
|---|---|
| 시험명: | Regulatory Affairs Certification (RAC) US |
| 시험 번호: | RAC-US |
| 관련 자격증: | RAC-EU RAC-Global RCC RAC-Canada |
| 합격 점수: | 환산 점수 75점 |
| 시험 형식: | 적용, 분석, 컴퓨터 기반 시험, 지식 회상, 객관식 |
| 응시료: | USD 605 (RAPS 회원), USD 760 (비회원) |
| 시험 시간: | 120분 |
| 자격증 유효 기간: | 3년 |
| 지원 언어: | English |
| 실제 시험 문항 수: | 100 |
| 샘플 문제: | RAPS RAC-US 샘플 문제 |
| 응시 방법: | Pearson VUE 시험 센터 또는 온라인 감독 시험 (OnVUE) |
| 전제 조건: | 학사 학위 및 3년의 규제 업무 경력, 또는 석사 학위 및 2년의 규제 업무 경력, 또는 박사 학위 및 1년의 규제 업무 경력. |
| 공식 요강 URL: | https://www.raps.org/certifications/rac |
RAPS RAC-US 시험 요강 주제:
| 섹션 | 목표 |
|---|---|
| 승인 후 및 라이프사이클 관리 | - 시판 제품 규정 준수
|
| 전략적 기획 | - 규제 전략 수립
|
| 규제 기관과의 소통 | - 규제 관련 소통 및 협상
|
| 시판 전 단계 | - 제품 개발 및 승인
|
최신 RAC Regulatory Affairs Certification RAC-US 무료샘플문제
문제 #1
During routine surveillance, a regulatory authority sent a company the following communication: "Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company's product. The regulatory authority is evaluating these issues to determine the need for any regulatory action." Which action would be the most appropriate
FIRST step for the company to take?
A. Contact the regulatory authority to argue that its conclusions are wrong.
B. Wait for the regulatory authority's final publication on its findings.
C. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
D. Contact the regulatory authority to discuss its findings.
문제 #2
A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?
A. Adverse event reports
B. Clinical investigations
C. Literature search
D. Clinical experience
문제 #3
Why is it necessary to run supplemental safety pharmacology studies?
A. To comply with regulatory authority requirements related to clinical studies
B. To substitute the utilization of GLP
C. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
D. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
문제 #4
A clinical study of a drug is completed to support a marketing approval application.
According to ICH, how long should a sponsor retain the clinical study essential documents?
A. For at least two years after the last approval of an application in an ICH region
B. Until the product has been discontinued from marketing in all ICH regions
C. For a minimum of 10 years after completion of the clinical study
D. Three years after the last clinical study site was supplied with investigational drugs
문제 #5
One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additional information to support the safety of your product. Assuming you have no additional data to provide, which of the following would be your MOST appropriate response to the regulatory authority's request?
A. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."
B. "We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary."
C. "We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."
D. "We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."
질문과 대답:
| 문제 #1 정답: D | 문제 #2 정답: B | 문제 #3 정답: C | 문제 #4 정답: A | 문제 #5 정답: B |
723 개 고객 리뷰
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