RAC-Drugs: Pharmaceutical Regulatory Affairs Practice
EXAM LATEST 130 QUESTIONS AND 100% Verified
ANSWERS JUST RELEASED
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of
the vendors comply with GMP requirements?
1. Ask the vendor to take responsibilities
2. Document and perform audits
3. Request an inspection from a regulatory authority
4. Request documentation from the sub-contractor
2. Document and perform audits
Which of the following changes to a drug product is MOST likely to be implemented without prior
regulatory authority approval?
1. Deleting an ingredient of the drug product
2. Deleting a drug substance
3. Introducing a new analytical method
4. Strengthening a precaution to the product labeling.
4. Strengthening a precaution to the product labeling.
A regulatory professional is requested to assist on a submission strategy for a non-innovative drug
authorized in one member state. What is the BEST strategy for the extension of the license in other
member states?
1. Use the Centralized Procedure
,2. Use the MRP
3. Request a CPP
4. Apply to each member state in turn
2. Use the MRP
The Centralized Registration procedure is compulsory for human medicines containing new active
substance to treat HIV, AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune diseases, and
other immune dysfunctions, and viral diseases.
True
False
True
During what period of the MRP should an individual within the applicant company always be available
to resolve any issues that may arise?
1. Five day period immediately following the close of the procedure.
2. Ten-day period for the preparation of the response document.
3. Ninety-day period for the reference member state to update the assessment report.
4. Ninety-day period for approval by the concerned member states.
4. Ninety-day period for approval by the concerned member states.
Which title of Directive 2001/83/EC, as amended, refers to the supply of samples?
1. Title III Placing on the Market
,2. Title VI Classification of Medicinal Products
3. Title VII Wholesale Distribution of Medicinal Products
4. Title VIIIa Information and Advertising
Title VIIIa Information and Advertising
A variation for a complex manufacturing change should include which of the following?
1. A statement and CV from an independent pharmaceutical consultant
2. An expert statement and CV from a quality expert.
3. An expert statement and CV from a clinical expert
4. An expert statement and the site quality head.
2. An expert statement and CV from a quality expert.
When advertising, which type of information can be provided without limitations relative to medicinal
products?
1. Public advertising of reimbursable over-the-counter products
2. Direct to consumer advertising of prescription medicinal products
3. Disease information with no reference to a medicinal product
4. Comparative advertising
3. Disease information with no reference to a medicinal product
Which of the following is directly related to the stability of a product?
1. Contraindications
, 2. Dosing information
3. Expiration date
4. Sealing instructions
3. Expiration date
Which of the following is FALSE regarding regulatory meetings between CBER and sponsors of
biological products?
1. Meetings may be electronically recorded.
2. The questions submitted to CBER within a single meeting request should be limited to those that can
be reasonably answered within the allotted meeting time, considering the complexity of the questions.
3. The meeting package should generally not contain more than 10 questions for any one discipline or
more than 30 for all disciplines.
4. The meeting requester or other meeting participant may submit to CBER a memorandum
summarizing their understanding of issues discussed at the meeting.
1. Meetings may be electronically recorded.
A marketing authorization holder (MAH) for a drug-led combination product received a customer
complaint that the drug-delivery device had malfunctioned; however, there was no adverse event.
According to the MAH's risk analysis, the malfunction could have resulted in serious injury if it were to
recur. What action should the MAH take, if applicable, to report the event to the FDA?
1. Submit the device malfunction report to the FDA CDRH eMDR (electronic Medical Device Reporting)
database.
2. Submit the device malfunction report as part of the Individual Case Safety Report (ICSR).
3. As there is no adverse event, the MAH is not obligated to report the event to the FDA.
4. Submit the device malfunction report to the eMDR database and as an ICSR.
2. Submit the device malfunction report as part of the Individual Case Safety Report (ICSR).
EXAM LATEST 130 QUESTIONS AND 100% Verified
ANSWERS JUST RELEASED
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of
the vendors comply with GMP requirements?
1. Ask the vendor to take responsibilities
2. Document and perform audits
3. Request an inspection from a regulatory authority
4. Request documentation from the sub-contractor
2. Document and perform audits
Which of the following changes to a drug product is MOST likely to be implemented without prior
regulatory authority approval?
1. Deleting an ingredient of the drug product
2. Deleting a drug substance
3. Introducing a new analytical method
4. Strengthening a precaution to the product labeling.
4. Strengthening a precaution to the product labeling.
A regulatory professional is requested to assist on a submission strategy for a non-innovative drug
authorized in one member state. What is the BEST strategy for the extension of the license in other
member states?
1. Use the Centralized Procedure
,2. Use the MRP
3. Request a CPP
4. Apply to each member state in turn
2. Use the MRP
The Centralized Registration procedure is compulsory for human medicines containing new active
substance to treat HIV, AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune diseases, and
other immune dysfunctions, and viral diseases.
True
False
True
During what period of the MRP should an individual within the applicant company always be available
to resolve any issues that may arise?
1. Five day period immediately following the close of the procedure.
2. Ten-day period for the preparation of the response document.
3. Ninety-day period for the reference member state to update the assessment report.
4. Ninety-day period for approval by the concerned member states.
4. Ninety-day period for approval by the concerned member states.
Which title of Directive 2001/83/EC, as amended, refers to the supply of samples?
1. Title III Placing on the Market
,2. Title VI Classification of Medicinal Products
3. Title VII Wholesale Distribution of Medicinal Products
4. Title VIIIa Information and Advertising
Title VIIIa Information and Advertising
A variation for a complex manufacturing change should include which of the following?
1. A statement and CV from an independent pharmaceutical consultant
2. An expert statement and CV from a quality expert.
3. An expert statement and CV from a clinical expert
4. An expert statement and the site quality head.
2. An expert statement and CV from a quality expert.
When advertising, which type of information can be provided without limitations relative to medicinal
products?
1. Public advertising of reimbursable over-the-counter products
2. Direct to consumer advertising of prescription medicinal products
3. Disease information with no reference to a medicinal product
4. Comparative advertising
3. Disease information with no reference to a medicinal product
Which of the following is directly related to the stability of a product?
1. Contraindications
, 2. Dosing information
3. Expiration date
4. Sealing instructions
3. Expiration date
Which of the following is FALSE regarding regulatory meetings between CBER and sponsors of
biological products?
1. Meetings may be electronically recorded.
2. The questions submitted to CBER within a single meeting request should be limited to those that can
be reasonably answered within the allotted meeting time, considering the complexity of the questions.
3. The meeting package should generally not contain more than 10 questions for any one discipline or
more than 30 for all disciplines.
4. The meeting requester or other meeting participant may submit to CBER a memorandum
summarizing their understanding of issues discussed at the meeting.
1. Meetings may be electronically recorded.
A marketing authorization holder (MAH) for a drug-led combination product received a customer
complaint that the drug-delivery device had malfunctioned; however, there was no adverse event.
According to the MAH's risk analysis, the malfunction could have resulted in serious injury if it were to
recur. What action should the MAH take, if applicable, to report the event to the FDA?
1. Submit the device malfunction report to the FDA CDRH eMDR (electronic Medical Device Reporting)
database.
2. Submit the device malfunction report as part of the Individual Case Safety Report (ICSR).
3. As there is no adverse event, the MAH is not obligated to report the event to the FDA.
4. Submit the device malfunction report to the eMDR database and as an ICSR.
2. Submit the device malfunction report as part of the Individual Case Safety Report (ICSR).
