QUESTION: 41

Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

Document any failure to follow regulatory compliance processes in employee performance reviews.
Develop documented procedures for regulatory compliance processes and train personnel.
Train all new employees on regulatory compliance processes and assign a mentor to them.
Train employees on all regulatory compliance processes using state-of-the-art systems.

Answer(s): B

A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.

During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.

What is the BEST response?

Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
Consult with the legal department to discuss the best course of action.
Review the regulatory guidelines to determine how to proceed.
Request a meeting with the regulatory authority to discuss the application.

Answer(s): D

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QUESTION: 43

Why is it necessary to run supplemental safety pharmacology studies?

To substitute the utilization of GLP
To comply with regulatory authority requirements related to clinical studies
To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
To provide adverse reaction reports and the results of the statistical data to the regulatory authority

Answer(s): C

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QUESTION: 44

Company X acquires Company Y. Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at Company X concludes that it is not feasible to meet this request within the time frame.

Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?

Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.
Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.
Submit as many labeling conversion applications as possible within the time frame and request an extension for the remaining ones.
Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.

Answer(s): A

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