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NEW QUESTION 29
Who has the PRIMARY responsibility for recall of products with quality defects?
- A. Manufacturer
- B. Consumer
- C. Regulatory authority
- D. Distributor
Answer: A
NEW QUESTION 30
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. File patents of interest in target countries.
- B. Use the community patent system.
- C. File design patents in target countries.
- D. Use the Madrid system.
Answer: A
NEW QUESTION 31
A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?
- A. Prepare regulatory submissions that detail the medical device's change in materials.
- B. Write a memo to file since the change does not impact product safety and effectiveness.
- C. No action is needed in this situation.
- D. Review the content of change and supporting data for the equivalency with the current material.
Answer: D
NEW QUESTION 32
What is the LAST stage in the development of a quality risk management process for a medical device?
- A. Risk acceptance
- B. Risk evaluation
- C. Risk analysis
- D. Risk reduction
Answer: A
NEW QUESTION 33
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. Abort the product launch.
- B. Inform the regulatory authorities.
- C. Correct the label text.
- D. Delay the start of product production.
Answer: B
NEW QUESTION 34
A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?
- A. Revision history
- B. Relevance to regulations
- C. Scope and level of detail
- D. Expiration date
Answer: B
NEW QUESTION 35
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?
- A. Export license
- B. Import license
- C. Site license
- D. Product license
Answer: C
NEW QUESTION 36
According to ICH, which of the following components of study information is NOT required in a clinical study report?
- A. Detailed CV of all investigators
- B. Randomization scheme and codes
- C. Protocol and protocol amendments
- D. List of lECs or lRBs
Answer: A
NEW QUESTION 37
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?
- A. Product distribution
- B. Plasma fractionation
- C. Plasma pooling
- D. Individual plasma donation
Answer: A
NEW QUESTION 38
In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?
- A. Product registration
- B. Product stability
- C. Product formulation
- D. Product requirements
Answer: B
NEW QUESTION 39
Which of the following BEST describes the process of post-marketing surveillance for healthcare products?
- A. Systematic procedure to review published scientific journals
- B. Systematic procedure to review experiences with the products in use
- C. Vigilance procedure to ensure the full traceability of the products
- D. Vigilance procedure to notify the regulatory authorities about serious incidents
Answer: C
NEW QUESTION 40
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. Specification
- B. Property
- C. Justification
- D. Formulation
Answer: C
NEW QUESTION 41
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. Until the product has been discontinued from marketing in all ICH regions
- B. For at least two years after the last approval of an application in an ICH region
- 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
Answer: B
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. Request documentation from the sub-contractor.
- C. Ask the vendor to take responsibility.
- D. Document and perform audits.
Answer: D
NEW QUESTION 43
A regulatory authority announces an inspection of a regulatory affairs professional's facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?
- A. Insist that key personnel be available for the inspection.
- B. Inform the authority that the time is not suitable and request a new time
- C. Arrange for an inspection without all intended personnel.
- D. Negotiate with colleagues and the authority to find a better time.
Answer: D
NEW QUESTION 44
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. Respond to the regulatory authority that the company will provide copies of the relevant
QC records for batch release. - B. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.
- C. Ask that the regulatory authority provide the actual product subject to the complaint.
- D. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit product.
Answer: B
NEW QUESTION 45
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 company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
- B. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.
- C. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
- D. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.
Answer: D
NEW QUESTION 46
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. Marketing materials
- B. Clinical trial data
- C. Safety issues
- D. Intellectual properly
Answer: C
NEW QUESTION 47
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?
- A. Class A
- B. Class C
- C. Class D
- D. Class B
Answer: B
NEW QUESTION 48
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