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. Fora minimum of 10 years after completion of the clinical study
C. Three years after the last clinical study site was supplied with investigational drugs
D. Until the product has been discontinued from marketing in all ICH regions
A company is currently marketing an implantable orthopedic medical device. The RandD department is planning to change the material used for the implant. The RandD 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. No action is needed in this situation.
B. Prepare regulatory submissions that detail the medical device's change in materials.
C. Review the content of change and supporting data for the equivalency with the current material.
D. Write a memo to file since the change does not impact product safety and effectiveness.
An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?
A. Stop product manufacturing.
B. Establish validation procedures.
C. Assess the impact of the changes.
D. Review the stability data for the changes.
The regulatory authority in Country X issued a request for a mandatory product recall in Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in Country Y?
A. Draft a formal letter to customers in Country Y about this recall.
B. Initiate a mandatory recall of the product in Country Y.
C. Review alt distribution records and complaints reported in Country Y.
D. Prepare the legal team in Country Y for possible litigations.
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?
A. Document any failure to follow regulatory compliance processes in employee performancereviews.
B. Develop documented procedures for regulatory compliance processes and train personnel.
C. Train all new employees on regulatory compliance processes and assign a mentor to them.
D. Train employees on all regulatory compliance processes using state-of-the-art systems.
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. Contact the regulatory authority to discuss its findings.
C. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
D. Wait for the regulatory authority's final publication on its findings.
Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?
A. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.
B. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
C. The manufacturer's experience level with the type of IVD medical device is limited.
D. The device incorporates well-established technology that is already present in the market.
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. Formulation
C. Property
D. Justification
Why is it necessary to run supplemental safety pharmacology studies?
A. To substitute the utilization of GLP
B. To comply with regulatory authority requirements related to clinical studies
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
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. Service operation procedures
C. Training program for sales people
D. Written procedure for product traceability
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