Alkaloid Pharmacovigilance Workshop Polls
1. The following is true about the PSMF:
- The MAH must provide a copy of the PSMF upon request from a National Competent Authority (NCA) within 7 calendar days from the request
- The MAH must provide a copy of the PSMF upon request from a National Competent Authority (NCA) within 15 calendar days from the request
- The MAH must provide a copy of the PSMF upon request from a National Competent Authority (NCA) within 30 calendar days from the request
2. Which of the following is not an objective of the PSMF:
- gain assurance that a pharmacovigilance system has been implemented in accordance with the requirements
- confirm aspects of compliance in relation to the system
- to have a solid marketing tool for promotion
3. In the EU, the PSMF must be located:
- in Liechtenstein
- either at the site where the main pharmacovigilance activities are performed or at the site where the qualified person responsible for pharmacovigilance operates
- wherever the MAH wants to store it
4. The Master File Location EVCode is obtained from:
- the EMA service desk
- the Organisation Management Services (OMS)
- the XEVMPD
5. The following is not a section of the PSMF:
- Organisational structure
- Pharmacovigilance processes
- Environmental policy and commitments
6. Section 1 of the PSMF “QPPV” should not contain:
- Proof of registration of the QPPV with EudraVigilance
- Details of back-up arrangements in case of QPPV absence
- QPPV training records
7. Section 2 of the PSMF “Organisational structure” should not contain:
- The site(s) where the pharmacovigilance functions are undertaken
- The site where the pharmacovigilance database is backed-up
- A description of the location and nature of contracts and agreements relating to the fulfilment of pharmacovigilance obligations should be provided (list/table)
8. Section 7 of the PSMF « Quality management systems » should contain a description of:
- Training
- Computerized system validation
- Unresolved minor findings from audits
9. Which of the following statements is false regarding PSURs:
- Frequency is subject to national/regional regulatory requirements
- Frequency and dates of submission may be laid down as a condition to the marketing authorisation
- Frequency and dates of submission can never be a condition to the marketing authorisation
10. The section worldwide marketing authorization status of the PSUR should not contain:
- Date of first approval (worldwide) – IBD
- Indication(s) and approved dose(s)
- A list of countries where the product is not authorized
11. Information on volume of sales in the PSUR:
- Should include donations
- Should not include donations
- Should include only what was not yet delivered from the warehouse
12. Which of the following is true regarding the section “Literature” of the PSUR?
- Search queries should not be wider than those used for the routine literature monitoring
- Never provide the MAHʼs comment on the findings with conclusion (how is it expected to impact B/R assessment of the product
- Should not be targeted only on articles regarding exposure in humans
13. Which of the following is not an appendix to the PSUR?
- Appendix 7 List of local contact points in the EU
- Appendix 1 Reference information
- Appendix 2 Summary tabulations of SAEs from clinical trials/ADRs from post-marketing experience
14. Which of the following is not part of the data quality review of ICSRs performed by the EMA?
- Data Quality Review of the content of ICSRs
- Recoding of Medicinal Product Information Provided in ICSRs
- Review of nullified ICSRs
15. The following errors in the ICSRs are classified as high impact errors by the EMA:
- Drugs incorrectly named to such an extent as to render them unidentifiable
- Incorrect or missing route of administration
- Information which should be in the case narrative, but is not, is in the Reporter’s comments or Sender’s comments
16. Which of the following errors in ICSRs is not considered a high impact error by the EMA?
- Invalid cases transmitted with the Outcome (e.g., hospitalisation) reported as reaction
- Invalid cases transmitted with multiple patients in a single case (e.g., from literature)
- Typographical error in the literature reference
17. Which of the following is not a trigger for a data quality review of ICSRs by the EMA?
Major changes to pharmacovigilance databases
Requests from pharmacovigilance inspectors
The time interval since the last review
Requests from GMP inspectors
18. The following is an acceptable reason for nullification of an ICSR:
Report sent previously in error
Patient did not take the suspect drug
Duplicate of an ICSR sent by a NCA
The suspect drug has been reclassified as concomitant drug and the concomitant drug was reclassified as suspect drug
19. Which of the following is not part of the section additional information on drug?
Counterfeit
Drug taken beyond expiry date
Drug taken as prescribed
Overdose
Medication error
Off-label use
Drug taken by the father
20. Which of the following is true about test results in an ICSR?
There are 4 ways to enter the results of a laboratory test: qualitative, quantitative, unstructured free text and comment
The most precise data element should be used among the different methods by which a test result can be provided
Test results are always included as unstructured text results
The qualitative test results must always be entered, in addition to the quantitative test results
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