Test 3

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Which term in the context of RAC (Drugs) does not describe the same concept as the others?

Monoclonal antibody (correct)

Follow-on protein products

Biosimilars

Subsequent entry biologics

According to ICH, what is the primary basis of assessment for the efficacy of antihypertensive drugs?

High systolic and diastolic blood pressures (correct)

Formal mortality and morbidity outcomes

Stroke and cardiovascular events

Organ damage secondary to hypertension

What aspect of safety database for anti-hypertensive drugs includes 461 patients exposed for three months?

Medium-term exposure subset

Short-term exposure subset (correct)

Long-term exposure subset

Intermediate-term exposure subset

In the safety database, what does a total exposure of 2.000 patients represent?

Cumulative exposure count Signup and view all the answers

Which factor is NOT typically considered in assessing the safety profile of an anti-hypertensive drug?

Geographical distribution of patients Signup and view all the answers

What characteristic distinguishes monoclonal antibodies from biosimilars and follow-on protein products?

Origin from recombinant DNA technology Signup and view all the answers

Which exposure subset is most likely to provide insights into potential long-term safety issues of the anti-hypertensive drug?

74 patients exposed for 12 months Signup and view all the answers

What parameter is crucial for evaluating the effectiveness of antihypertensive drugs based on ICH guidelines?

$\text{High systolic and diastolic blood pressures}$ Signup and view all the answers

Which of the following actions is considered a failure to allow an FDA investigator entry into a facility?

Certain staff members being unavailable during an unannounced inspection Signup and view all the answers

What is the correct action that restarts the review clock for a Biologics License Application (BLA) that received a non-approval letter?

Submitting a complete response to the non-approval letter Signup and view all the answers

If a supplier discontinues production of a resin used in a marketed drug product's container, what mechanism should a regulatory professional recommend to maintain compliance?

Submit a Prior Approval Supplement Signup and view all the answers

Which of the following actions by a facility is considered a failure to provide an FDA investigator with requested records?

Providing incomplete records without explanation Signup and view all the answers

What type of supplement should a regulatory professional recommend for a change in the manufacturing process of a marketed drug product?

Prior Approval Supplement Signup and view all the answers

If a regulatory professional submits a complete response to a non-approval letter for a Biologics License Application (BLA), what happens to the review clock?

The review clock is restarted from the date of the complete response submission Signup and view all the answers

Which of the following actions by a facility is considered a failure to allow an FDA investigator entry during an unannounced inspection?

Delaying the investigator's entry by a few hours without explanation Signup and view all the answers

What type of supplement should a regulatory professional recommend for a change in the container closure system of a marketed drug product?

Prior Approval Supplement Signup and view all the answers

What is the correct strategy for extending a license to other EU member states?

Use the Mutual Recognition Procedure (MRP) Signup and view all the answers

What is the legal status of European scientific guidelines?

They have no legal force but are highly recommended Signup and view all the answers

How many days after the start of the DCP Assessment Step I does the reference member state have to supply the draft labeling to the concerned member states and applicant?

120 days Signup and view all the answers

During which procedure should an applicant company representative be available to resolve any issues that may arise?

Both MRP and DCP Signup and view all the answers

What is the purpose of the Mutual Recognition Procedure (MRP)?

To extend an existing marketing authorization to other EU member states Signup and view all the answers

What is the Centralized Procedure with Prescription (CPP)?

A procedure for obtaining marketing authorization in all EU member states simultaneously Signup and view all the answers

What is the purpose of the Decentralized Procedure (DCP)?

To obtain initial marketing authorization in one EU member state Signup and view all the answers

What is the role of the CEN (European Committee for Standardization) in relation to European scientific guidelines?

The CEN has no direct role in relation to European scientific guidelines Signup and view all the answers

Which schedule would a drug with accepted medical use and limited potential for abuse be placed in?

Schedule IV Signup and view all the answers

A drug with a high potential for abuse and no currently accepted medical use would likely be categorized as which schedule?

Schedule I Signup and view all the answers

Which schedule is used for drugs with a moderate potential for abuse and currently accepted medical use?

Schedule III Signup and view all the answers

Drugs with a low potential for abuse and accepted medical uses are categorized under which schedule?

Schedule V Signup and view all the answers

Which controlled substance schedule has the most restrictive policies and regulations?

Schedule I Signup and view all the answers

A pharmaceutical with a $\delta$-9-THC concentration greater than 0.3% would likely be placed in which schedule?

Schedule I Signup and view all the answers

Which schedule covers drugs with currently accepted medical uses and a low potential for abuse?

Schedule V Signup and view all the answers

Drugs containing narcotics like codeine or opium would likely fall under which controlled substance schedule?

Schedule II Signup and view all the answers

What is the most appropriate next regulatory step after a clinical trial for a medicinal product has been finalized in several European countries?

File a declaration on the end of the clinical trial to the competent authorities and ethics committees of the participating countries Signup and view all the answers

According to ICH Q10, which of the following is NOT addressed by implementing a Pharmaceutical Quality System (PQS)?

A PQS can be certified through the ICH Q10 Certification Programme Signup and view all the answers

Which changes are parallel distributors allowed to introduce to the packaging of a centrally authorised medicinal product?

Use of different language versions of labelling and package leaflet Signup and view all the answers

A variation for a complex manufacturing change should include which of the following?

All of the above Signup and view all the answers

What is the correct acronym for the 'Medical Dictionary for Regulatory Activities'?

MedDRA Signup and view all the answers

Which of the following is NOT a component of the WHO Adverse Reactions Terminology?

None of the above Signup and view all the answers

What is the purpose of the MedDRA terminology?

To standardize the coding of adverse event information in clinical trials Signup and view all the answers

Which of the following is NOT a benefit of implementing a Pharmaceutical Quality System (PQS) according to ICH Q10?

Reducing the frequency of regulatory inspections Signup and view all the answers

Test 3

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Questions and Answers

Which term in the context of RAC (Drugs) does not describe the same concept as the others?

According to ICH, what is the primary basis of assessment for the efficacy of antihypertensive drugs?

What aspect of safety database for anti-hypertensive drugs includes 461 patients exposed for three months?

In the safety database, what does a total exposure of 2.000 patients represent?

Which factor is NOT typically considered in assessing the safety profile of an anti-hypertensive drug?

What characteristic distinguishes monoclonal antibodies from biosimilars and follow-on protein products?

Which exposure subset is most likely to provide insights into potential long-term safety issues of the anti-hypertensive drug?

What parameter is crucial for evaluating the effectiveness of antihypertensive drugs based on ICH guidelines?

Which of the following actions is considered a failure to allow an FDA investigator entry into a facility?

What is the correct action that restarts the review clock for a Biologics License Application (BLA) that received a non-approval letter?

If a supplier discontinues production of a resin used in a marketed drug product's container, what mechanism should a regulatory professional recommend to maintain compliance?

Which of the following actions by a facility is considered a failure to provide an FDA investigator with requested records?

What type of supplement should a regulatory professional recommend for a change in the manufacturing process of a marketed drug product?

If a regulatory professional submits a complete response to a non-approval letter for a Biologics License Application (BLA), what happens to the review clock?

Which of the following actions by a facility is considered a failure to allow an FDA investigator entry during an unannounced inspection?

What type of supplement should a regulatory professional recommend for a change in the container closure system of a marketed drug product?

What is the correct strategy for extending a license to other EU member states?

What is the legal status of European scientific guidelines?

How many days after the start of the DCP Assessment Step I does the reference member state have to supply the draft labeling to the concerned member states and applicant?

During which procedure should an applicant company representative be available to resolve any issues that may arise?

What is the purpose of the Mutual Recognition Procedure (MRP)?

What is the Centralized Procedure with Prescription (CPP)?

What is the purpose of the Decentralized Procedure (DCP)?

What is the role of the CEN (European Committee for Standardization) in relation to European scientific guidelines?

Which schedule would a drug with accepted medical use and limited potential for abuse be placed in?

A drug with a high potential for abuse and no currently accepted medical use would likely be categorized as which schedule?

Which schedule is used for drugs with a moderate potential for abuse and currently accepted medical use?

Drugs with a low potential for abuse and accepted medical uses are categorized under which schedule?

Which controlled substance schedule has the most restrictive policies and regulations?

A pharmaceutical with a $\delta$-9-THC concentration greater than 0.3% would likely be placed in which schedule?

Which schedule covers drugs with currently accepted medical uses and a low potential for abuse?

Drugs containing narcotics like codeine or opium would likely fall under which controlled substance schedule?

What is the most appropriate next regulatory step after a clinical trial for a medicinal product has been finalized in several European countries?

According to ICH Q10, which of the following is NOT addressed by implementing a Pharmaceutical Quality System (PQS)?

Which changes are parallel distributors allowed to introduce to the packaging of a centrally authorised medicinal product?

A variation for a complex manufacturing change should include which of the following?

What is the correct acronym for the 'Medical Dictionary for Regulatory Activities'?

Which of the following is NOT a component of the WHO Adverse Reactions Terminology?

What is the purpose of the MedDRA terminology?

Which of the following is NOT a benefit of implementing a Pharmaceutical Quality System (PQS) according to ICH Q10?

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