PHARMACOVIGILANCE

Question 1

PHARMACEUTICAL INDUSTRY ON PHARMACOVIGILANCE

Answer 1

RA 9711

Question 2

FDA CIRCULAR 2020-003

Answer 2

PHARMACOVIGILANCE

Question 3

In Phase__________of the clinical trials, information is not enough.

Answer 3

1 - 3

Question 4

was issued to monitor the safety and efficacy of drug products, establishing the National Policy and Program on Pharmacovigilance

Answer 4

ADMINISTRATIVE ORDER NO. 2011 -0009

Question 5

Post Market Surveillance and Periodic Safety Update Report

Answer 5

FDA Circular No. 2013 003

Question 6

Post Market Surveillance of Authorized Drug Products

Answer 6

FDA Circular No. 2013 004

Question 7

Post marketing surveillance requirement for New Drugs under Monitored Release

Answer 7

FDA Circular No. 2018 012

Question 8

T/F: Circular shall cover ALL MAH and drug establishments involved in the IMPORTATION and distribution of registered drug and biological products for human use.

Answer 8

True

Question 9

A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.

Answer 9

ADVERSE DRUG REACTION ADR

Question 10

also refers to adverse events following immunization if the product involved is vaccine

Answer 10

ADVERSE DRUG REACTION ADR

Question 11

It also refers to adverse reaction, suspected adverse (drug) reaction, side effect or undesirable effect

Answer 11

ADVERSE DRUG REACTION ADR

Question 12

Any untoward medical occurrence which follows immunization and which does not necessarily have causal relationship with the usage of vaccine

Answer 12

ADVERSE EVENTS FOLLOWING IMMUNIZATION AEFI

Question 13

Commonly, when we say AEFI, it refers to

Answer 13

fever, muscle weakness, or muscle pain

Question 14

An adverse reaction which results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization

Answer 14

SERIOUS ADVERSE REACTION

Question 15

T/F: Biological mediinal products consist higher molecular weight

Answer 15

True

Question 16

NDP may refer to

Answer 16

● New mode of administration
● New dosage strength
● New dosage form
● New fixed combination of two or more active
ingredients
● New chemical or structural modification of a tried
and tested or established drug

Question 17

The MAH must designate a pharmacovigilance officer which also refers to as

Answer 17

Qualified Person for Pharmacovigilance QPPV

Question 18

functions of QPPV

Answer 18

maintain an effective pharmacovigillance system

Question 19

MAH holds authorizations act as a ______________ during inspection and monitoring and respond promptly for any request/inquiry from _________

Answer 19

single contact point; FDA

Question 20

Requirements to become QPPV

Answer 20

baccalaureate degree in medically-related courses

residing within the Ph territory

Question 21

T/F: Not only Pharmacists can be QPPV

Answer 21

True

Question 22

T/F: Records must be available and provided upon request during inspection by the FDA

Answer 22

True

Question 23

Records must be available and provided upon request for submission to the

Answer 23

Pharmacovigilance Section, Product Research and Standards Development Division PRSDD , Center for Drug Regulation and Research CDRR .

Question 24

Reports of serious adverse reactions, whether expected or unexpected must be submitted to FDA as soon as possible but no later than _________ calendar days

Answer 24

15

Question 25

The reporting time clock starts after

Answer 25

first knowledge of any personnel of the MAH on the said adverse reaction

Question 26

The lack of any of the four elements means that the case is considered ___________ and _________ (qualifies/does not qualify) for submission.

Answer 26

incomplete; does not qualify

Question 27

T/F: Adverse reaction obtained from a data collection system are considered spontaneous

Answer 27

False: not considered

Question 28

T/F: Only serious solicited adverse reactions are to be submitted to the FDA.

Answer 28

True

Question 29

responsible for submission of reports to the FDA and requirements from the Circular.

Answer 29

MAH

Question 30

T/F: Outcomes of use during pregnancy must be reported only if there is an abnormal outcome to the baby such as congenital anomaly and malformation

Answer 30

True

Question 31

If both the parent and child suffered adverse reactions, how many reporst are to be made?

Answer 31

2 seperate reports but still linked to each other

Question 32

Suspended, cancelled or withdrawn product registration must have continuous collection of reports for up to ___________ after the date of the last release

Answer 32

3 years

Question 33

T/F: Submission of RMP for a generic drug is required

Answer 33

False; not required

Question 34

conducted locally for all registered drugs and biological products for human use

Answer 34

Routine Pharmacovigilance Activities

Question 35

pharmacovigilance considered routine.

Answer 35

Additional Pharmacovigilance Activities

Question 36

What category: Imposed because they are key to the risk-benefit profile of the product

Answer 36

1

Question 37

What category: Specific obligations granted under exceptional circumstances

Answer 37

2

Question 38

What category: Required to investigate a safety concern or to evaluate the effectiveness of risk minimization activities.

Answer 38

3

Question 39

present a comprehensive, concise, and critical analysis of new or merging information on the risks of the medicinal product, and on its benefit in approved indications, to enable an appraisal of the product’s overall benefit-risk profile.

Answer 39

PERIODIC BENEFIT-RISK EVALUATION REPORTS (PBRER)

Question 40

should contain an evaluation of new information relevant to the medicinal product that became available to the MAH during the reporting interval

Answer 40

PERIODIC BENEFIT-RISK EVALUATION REPORTS (PBRER)

Question 41

PBRER is also referred to as

Answer 41

Periodic Safety Update Report PSIJR

Question 42

Regulatory actions taken by other national drug regulatory authorities which may influence the overall benefit-risk profile of the product must be communicated to the

Answer 42

Pharmacovigilance Section, FDACDRR, PRSDD

Question 43

Regulatory actions taken by other national drug regulatory authorities which may influence the overall benefit-risk profile of the product must be communicated to the Pharmacovigilance Section, FDACDRR, PRSDD as soon as possible but not later than

Answer 43

72 hours after the receipt of information.

Question 44

T/F: The conduct of pharmacovigilance inspection will generally be upon notice, however, the FDA reserves the right to conduct unannounced inspection, if necessary.

Answer 44

True