Online Access Free RAC-GS Practice Test

The safety database for an anti-hypertensive drug consists of the following:
461 patients exposed for three months
343 patients exposed for six months
112 patients exposed for nine months
74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

• A.100 patients for 12 months
• B.200 patients for nine months
• C.500 patients for three months
• D.3.000 total patient exposures

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 design patents in target countries.
• B.Use the community patent system.
• C.Use the Madrid system.
• D.File patents of interest in target countries.

A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect of the SOP Is MOST important to consider?

• A.Relevance to regulations
• B.Expiration date
• C.Scope and level of detail
• D.Revision history

Which of the following situations does NOT require rapid communication to regulatory authorities?

• A.A lack of efficacy with a medicinal product used in treating a life-threatening disease
• B.A clinically important increase in the rate of occurrence of an "expected." but serious ADR
• C.A major safety finding from a newly completed animal carcinogenicity study
• D.A statistically significant increase in the number of deaths in an animal dose finding study

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 regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.
• B.Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
• C.Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
• D.Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.