QPPV.COM KNOWLEDGE ASSESSMENT

Selecting and Appointing a QPPV: In-House, External and Hybrid Models

Test your understanding of the concepts covered by Selecting and Appointing a QPPV: In-House, External and Hybrid Models.

Question 1 of 10Pass mark: 80%

Question 1 of 10 When conducting due diligence on an external QPPV provider, what should the MAH evaluate in addition to the provider's reputation?

Only the provider's marketing materials The specific individual, supporting system, capacity, access, conflicts and continuity arrangements Only the provider's office location Whether the provider offers the lowest hourly rate

Question 2 of 10 A critical vendor has not breached its contractual tolerance, but its reporting performance has deteriorated steadily. What does the article suggest the QPPV should do?

Take no action until a formal breach occurs Assess the trend, gather evidence and consider proportionate investigation or escalation before the problem becomes a serious failure Terminate the vendor immediately without further assessment Allow the vendor to define whether the trend is significant

Question 3 of 10 Which characteristic is a potential advantage of an in-house QPPV, but not an automatic guarantee of compliance?

Potential integration with company systems, management and operational information Automatic independence from commercial priorities Elimination of the need for a backup arrangement Removal of the MAH's responsibility for outsourced activities

Question 4 of 10 What is the most important principle when selecting an operating model for the QPPV?

The model should use the least expensive qualified individual The model should give the QPPV sufficient competence, capacity, access, authority and continuity within the actual PV system The model should ensure that the QPPV personally performs all PV activities The model should always place the QPPV directly within the MAH's legal department

Question 5 of 10 Which factor should most strongly influence the amount of QPPV involvement required?

Whether the QPPV prefers internal or external employment The complexity, geographic scope, outsourcing profile, safety profile and regulatory demands of the PV system The age of the company's corporate logo Whether the QPPV has a managerial title

Question 6 of 10 Why may an external QPPV model be particularly practical for a small or virtual MAH?

It allows the MAH to avoid maintaining a pharmacovigilance system It can provide experienced QPPV expertise without requiring a large internal PV function It removes the need for management escalation It permits the QPPV to operate outside the Union

Question 7 of 10 Why should contractual promises about QPPV availability be tested against operating procedures?

Contracts are irrelevant to external QPPV arrangements A promise is weak if the organisation has no practical mechanism to contact or support the QPPV when needed The QPPV may only be contacted through the safety database Operating procedures can replace all contractual requirements

Question 8 of 10 Which statement best describes the relationship between the MAH and the QPPV under EU pharmacovigilance requirements?

The QPPV assumes the MAH's regulatory accountability when appointed The service provider assumes responsibility for the pharmacovigilance system when the QPPV is external The MAH remains responsible for the pharmacovigilance system, while the QPPV provides qualified oversight within that system The competent authority becomes responsible for system performance once a QPPV is appointed

Question 9 of 10 A small MAH is comparing a part-time internal QPPV with an external QPPV. Which decision process best follows the article?

Select the internal candidate automatically because employment status is preferred Select the lower-cost option without mapping the PV system Map information flows, vendor oversight, escalation, PSMF ownership, governance participation and absence coverage before comparing the models Choose the candidate with the greatest number of years of experience regardless of availability

Question 10 of 10 Which assessment is most appropriate when evaluating a candidate's capacity for an external QPPV role?

Review only the candidate's academic qualifications Determine the candidate's other QPPV roles, workload, availability and ability to respond to urgent issues Assume that a consultancy's reputation proves individual availability Assess only whether the candidate can attend a monthly meeting

Selecting and Appointing a QPPV: In-House, External and Hybrid Models

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