Regulatory Affairs Certification - GS

Total Questions: 100
Update Date: May 20, 2024

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Question 1

According to ICH, which of the following components of study information is NOT required in a clinical study report?

A. Randomization scheme and codes 
B. Protocol and protocol amendments 
C. ListoflECsorlRBs 
D. Detailed CVofall investigators 

Answer: D

Question 2

The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?

A. The process information and analytical result of Company X API 
B. The process information and analytical result of Company Y API 
C. The process information and the comparative analytical result of APIs from both companies
D. Information deemed appropriate by the regulatory authority

Answer: C

Question 3

Which of the following BEST describes the content of the "Physical, Chemical, and Pharmaceutical Properties and Formulation" section of an IB? 

A. A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation 
B. A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use
C. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
D. A brief summary of relevant physical, chemical, and pharmaceutical properties: instructions for storage and handling of the dosage form: and a description of the formulation

Answer: D

Question 4

As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST? 

A. Site license 
B. Product license 
C. Import license 
D. Export license 

Answer: A

Question 5

What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

A. Safety and failure risk 
B. Safety and effectiveness 
C. Quality and failure risk 
D. Quality and effectiveness 

Answer: B

Question 6

In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation. However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST? 

A. Discuss with the regulatory apriority and attempt to reach an acceptable solution. 
B. Inform the internal departments to redesign the product to comply with this requirement. 
C. Inform the regulatory authority that such a requirement is not applicable to the product. 
D. Notify senior management that the product cannot be registered. 

Answer: A

Question 7

Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device? 

A. Fishbone analysis 
B. Failure modes, effects, and criticality analysis 
C. Fault tree analysis  
D. Quality by design analysis 

Answer: B

Question 8

Which of the following double-blind clinical trial designs would be MOST appropriate for a Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy? 

A. Active-controlled 
B. Cross-over 
C. Dose-ranging 
D. Placebo-controlled 

Answer: B

Question 9

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 both identification and non-clinical qualification studies concurrently. 
C. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study. 
D. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.

Answer: C

Question 10

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. Plasma fractionation 
B. Product distribution 
C. Individual plasma donation 
D. Plasma pooling 

Answer: B