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The RAC-US exam is a challenging but rewarding certification program that is highly respected in the regulatory affairs industry. It provides regulatory affairs professionals with an opportunity to demonstrate their expertise, advance their careers, and make a meaningful contribution to the healthcare industry.
RAPS RAC-US (Regulatory Affairs Certification US) exam is a professional certification exam designed for regulatory professionals in the United States. RAC-US exam is created and administered by the Regulatory Affairs Professionals Society (RAPS) to test the knowledge and expertise of regulatory professionals in the US. Passing the RAC-US exam demonstrates a regulatory professional's ability to understand and navigate the complex regulatory environment of the United States.
The Regulatory Affairs Certification (RAC) US exam is a professional certification for individuals who work in regulatory affairs. RAC-US exam is designed to test the knowledge and skills necessary for professionals to work effectively in regulatory affairs and to ensure that they are up-to-date with the latest regulations and standards. The RAC-US certification is awarded by the Regulatory Affairs Professionals Society (RAPS), a global organization dedicated to promoting regulatory excellence.
NEW QUESTION # 41
The safety database for an anti-hypertensive drug consists of the following:
* 461 patients exposed for three months
* 343 patients exposed for six months
* 112 patients exposed for nine months
* 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?
- A. 500 patients for three months
- B. 3.000 total patient exposures
- C. 200 patients for nine months
- D. 100 patients for 12 months
Answer: D
NEW QUESTION # 42
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?
- A. Request an inspection from a regulatory authority.
- B. Document and perform audits.
- C. Ask the vendor to take responsibility.
- D. Request documentation from the sub-contractor.
Answer: B
NEW QUESTION # 43
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Phase III clinical trials
- B. Pre-clinical studies
- C. Phase I clinical trials
- D. Phase I and II clinical trials
Answer: A
NEW QUESTION # 44
Which of the following claims would classify an apple as a drug?
- A. "It will prevent colds."
- B. "It will whiten teeth."
- C. "It will make you look younger."
- D. "It will satisfy hunger."
Answer: A
NEW QUESTION # 45
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?
- A. "Is the product profitable for the manufacturer?"
- B. "Is the product an established gold standard?"
- C. "Has the product been approved for mor&4nan 10 years?"
- D. "Is the product better than currently available alternatives?"
Answer: D
NEW QUESTION # 46
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?
- A. Efficacy and material
- B. Compatibility and safety
- C. Volume and material
- D. Safety and efficacy
Answer: B
NEW QUESTION # 47
According to ICH, which of the following components of study information is NOT required in a clinical study report?
- A. Protocol and protocol amendments
- B. List of lECs or lRBs
- C. Detailed CV of all investigators
- D. Randomization scheme and codes
Answer: C
NEW QUESTION # 48
The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?
- A. Quality
- B. Regulatory
- C. Analytical
- D. Production
Answer: A
NEW QUESTION # 49
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?
- A. Malfunction protection operated correctly
- B. Deficiency of a device found by the user prior to patient use
- C. Malfunction occurring before the end of service life of the medical device
- D. Adverse event caused by patient conditions
Answer: D
NEW QUESTION # 50
A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the
WHO recommendations?
- A. Certificate of GMP
- B. Certificate of Free Sale
- C. Certificate of Pharmaceutical Product
- D. Certificate of Analysis for the finished product
Answer: C
NEW QUESTION # 51
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product
Is distributed globally.
Which of the following is the most appropriate action to take FIRST?
- A. Send a "Dear Dr." letter to customers.
- B. Notify the global regulatory authorities.
- C. Withdraw the affected product from the markets.
- D. Assess the potential safety risk.
Answer: B
NEW QUESTION # 52
A regulatory affairs professional has submitted a package for regulatory review.
According to the regulation, the regulatory authority will need to respond within 90 days of submission.
If there is no response after the deadline, what is the BEST approach?
- A. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
- B. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.
- C. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
- D. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.
Answer: B
NEW QUESTION # 53
During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?
- A. Perform either an identification study or a non-clinical qualification study.
- B. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
- C. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.
- D. Perform both identification and non-clinical qualification studies concurrently.
Answer: B
NEW QUESTION # 54
A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?
- A. Formulation
- B. Property
- C. Specification
- D. Justification
Answer: D
NEW QUESTION # 55
A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?
- A. Guidance documents for the device
- B. Determination of product design deliverables
- C. Approved indications of the drug
- D. Determination of primary mode of action
Answer: B
NEW QUESTION # 56
Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?
- A. Safety issues
- B. Marketing materials
- C. Intellectual properly
- D. Clinical trial data
Answer: A
NEW QUESTION # 57
Which of the following is NOT required to be included in a marketing application?
- A. Evidence of fee payment
- B. Administrative forms
- C. Quality, safety, and efficacy Information
- D. Final printed label
Answer: A
NEW QUESTION # 58
Company X and Company Y both have products for the treatment of rare genetic diseases.
Company X would like to acquire Company Y but does not know enough about Company Y to make an offer.
What is the MOST appropriate approach that Company X should take to acquire more information about Company Y?
- A. Enter into an agreement with Company Y to perform due diligence.
- B. Recruit a professional to gather confidential intelligence on Company Y.
- C. Perform a thorough library search to gather detailed information on Company Y.
- D. Request the needed information from the Board of Directors of Company Y.
Answer: A
NEW QUESTION # 59
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