RAPS RAC Regulatory Affairs Certification RAC-GS Questions & Answers

• Question 41:

  According to the ICH guideline on GMP for API,to which of the following is the MOST stringent requirement applied?

  A. Physical processing and packaging

  B. Isolation and purification

  C. Production of Intermediate(s)

  D. Introduction of the API starting material

  Correct Answer: A

• Question 42:

  A company establishes a new medical device indication for its consumer disposable products. The regulatory affairs professional is asked to give a 30-minute training session on these products to sales representatives. Which of the following subjects is the MOST important to discuss?

  A. Labeling

  B. Regulatory application summary

  C. Risk management process

  D. Safety-related reporting

  Correct Answer: A

• Question 43:

  A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?

  A. Doha Declaration in the TRIPS Agreement

  B. The stability of the drug in all zone conditions

  C. The time frame in which the patent will expire

  D. International import and export regulations

  Correct Answer: B

• Question 44:

  A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.

  What should be done. What action should the company take FIRST?

  A. Initiate testing immediately to ensure compliance.

  B. Consult with colleagues about the request.

  C. Contact the regulatory authority that issued this request and discuss the requirement.

  D. Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.

  Correct Answer: C

• Question 45:

  The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.

  Which of the following actions should the regulatory affairs professional take?

  A. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.

  B. Ask that the regulatory authority provide the actual product subject to the complaint.

  C. Respond to the regulatory authority that the product subject to the complaint is most likely acounterfeit product.

  D. Respond to the regulatory authority that the company will provide copies of the relevant QCrecords for batch release.

  Correct Answer: A

• Question 46:

  As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?

  A. Inform the regulatory authorities.

  B. Delay the start of product production.

  C. Correct the label text.

  D. Abort the product launch.

  Correct Answer: A

• Question 47:

  A global company has obtained a patent in a specific country for a newly marketed product. What would be the BEST advice In order to protect the patent in other countries?

  A. Use the Madrid system.

  B. Use the community patent system.

  C. File patents of interest in target countries.

  D. File design patents in target countries.

  Correct Answer: C

• Question 48:

  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. Ask the vendor to take responsibility.

  B. Document and perform audits.

  C. Request an inspection from a regulatory authority.

  D. Request documentation from the sub-contractor.

  Correct Answer: B

• Question 49:

  A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

  A. Documented agreement

  B. Frequent communication

  C. Early collaboration

  D. Follow-up meeting after submission

  Correct Answer: B

• Question 50:

  Which of the following claims would classify an apple as a drug?

  A. "It will make you look younger."

  B. "It will satisfy hunger."

  C. "It will whiten teeth."

  D. "It will prevent colds."

  Correct Answer: D