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Drug Regulatory Affairs > Pharmacovigilance > Flashcards

Pharmacovigilance Flashcards

1
Q

what is Pharmacovigilance?

A

it is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or nay other possible drug-related problems

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2
Q

Nowadays Pv includes?

A

herbals, traidtional medcine, blood products, biologicals, medical devices, vaccines

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3
Q

What is the purpose of PV?

A 
Provide optimals information to users
identify new information or hazard associated with medicines
Evaluate changes in benefits and risk
Monitor impact of actions taken
prevent harm to patients
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4
Q

PV Legislation in the EU

A

Regulation and directive in the EU and Clinical trials legislation

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5
Q

what is the pharamcovigilance system master file?

A

it describes the pharmacovigilance system used by the marketing authorisation holder (MAH) and documents the compliance with legal requirements

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6
Q

QPPV stands for?

A

Qualified person responsible for pharmacovigilance

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7
Q

What are the key tasks of the QPPV

A

Implementation and maintenance of the pharmacovigilance system
overview of the benefit-risk profile of all approved drugs
contact person for regulatory authorities (24 hourse a day) and for inspections

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8
Q

Who is a QPPV?

A

a natural person, having knowledge for the performace of PV activities and has acees to experties in relavent areas such as medicine, pharamceutical sciences as well as epidemiology and biostatistics

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9
Q

QPPV should be?

A

24/7 availability for national comptent authorities and EMA
be independent from the board or directors
must reside in the Community (EU/EEA)

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10
Q

which measures are taken by the EMA in PV

A

Monitor the outcome of the rsik minimisation measures contained in risk management plan
Assess updates to the risk managment system
Evaluate the data in the EudraVigilance database

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11
Q

what is the graduted plan?

A

it is a rational aprroach to drug risks, a national risk assessment procedure

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12
Q

Hazard Level 1

A

Reached as soon as reports to the possibility of newly emerged drug risks
Affected company has to be informed, contacting stakeholders of the graduated plan

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13
Q

Hazard Level 2

A

initiated after level 1 or in the case of high risks

Consultation of the level plan officer and initiation f measures Announcement of measures to reduce7 avoid the risks

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14
Q

GPO

A

Graduated Plan Officer

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15
Q

GPO is?

A

a qualified person who is resident in a MS of the EU

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16
Q

what are the function of the GPO?

A

Set up and mange a PV system
collect and evalute notifications on medicinal product risk that have become known
Co-ordinate the necessary measures

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17
Q

the granuated plan officer is resonsible for?

A

medicinal and pharmceutical defects

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18
Q

Differeces between EU-QPPV and GPO in their resonsible

A

EU: QPPV: the complete European PV system
GPO: local German PV system

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19
Q

Differeces between EU-QPPV and GPO in their Availability

A

EU-QPPV: single PV ontact point for the comptent authorities in MS and the Agency on a -hour basis
GPO: No requirements (normal office hours)

20
Q

Product techinal complaints (EU-QPPV and GPO)

A

EU-QPPV: no resonsibility

GPO: Responsible for all product technical complaints reported

21
Q

Safety of IMPS (EU-QPPV and GPO)

A

EU-QPPV: no resonsibility

GPO: Responsible about all product risk also concerning investigation medicinal products

22
Q

Liability (EU-QPPV and GPO)

A

EU-QPPV: No special rules

GPO: Personally liable

23
Q

Quantity (EU-QPPV and GPO)

A

EU-QPPV: Only one QPPV/ company

GPO: Allowed to have multiple GPO per company (one for PV, for complaints and for CS)

24
Q

Different between Adverse event and reaction

A

Adverse Event are events which are does not necessarily have to have a causal relationship with the treatment
Advers Reaction: it is response to a medicial product which is noxious and unintended
A causal relationship between a medicinla product and an anvser event is at last a resonable possibility

25
Q

Serioud adverse reaction?

A

adversse reaction which results in death, is life-threatening

26
Q

unexpected adverse reaction

A

an adverse reaction, the nature, severity or outcome of which is not consistent with SmPC

27
Q

Safety Signals

A

Information on a new or know adverse event/ reaction that ia potentially caused by a medicine and that warrent further investigation

28
Q

Classification of adcerse reaction

A
  1. Case reports are assessed for validity
  2. meets the minimum criteria
  3. the receipt data or day 0
  4. Case reports will be assessed for regulatory reporting
29
Q

what the 4 minimum criteria

A

An identifiable reporter
an identifiable patient
At least one suspected substnace/ medicinal product
At least one suspected adverse reaction

30
Q

the Receipte Date /Day 0 is defined as?

A

the date on which the MAH had first awareness of the adverse event or the date when a contract or licensing partner of the MAH had first awareness

31
Q

the case report takes into consideration

A

Seriousness
Expectedness
Causailty (Relatedness)

32
Q

unecpected events?

A

when the nature of severity is not consistent with the SmPC

33
Q

Causality?

A

is the relationship of the reported event to the drug

34
Q

What happends to AR information?

A

they are used to determine the benefit-risk profile of the product

35
Q

What are some result of the AR information

A

Comminication with comptent Authorities
Recall of Bacthes/products
Chnages to the patient information leaflet and updates to the SmPC
Wthdrawal of the product from the market

36
Q

Black Triangle

A

Additional monitoring typically for product that are new, or have had a new indication or formulation approved

37
Q

timelines ofr reporting

A

Post-marketing:
EU: Serious individual Case safety reporting (ICSR) 15 days
Nono-serious ICSR 90 days at the EudroVigilance Database

US: Serious unexpected ICSRs 15 days

Clinical study:
Suspected unexpected serious adverse reaction (SUSARs)

38
Q

Clinical study:

Suspected unexpected serious adverse reaction (SUSARs) include

A

Fatel or life-threatening 7 days

other SUSARs 15 day

39
Q

Medical Dictinary for regulatory activites (MedDRa)

A

a standardised medical terminology used by regulatory authorites and the phramceutica industry throughout the entire regulatory process, from pre-marketing to post-marketing activites

40
Q

MadDRA is managed by

A

MSSO : Maintenance and support Services Organization

41
Q

EudraVigilance?

A

is the system for mangaing and analysing information on suspected adverse reactions to medicines which have been authroised or being studies in clinical trials in the European Economic Area

42
Q

what are the activies of the EudraVigilance?

A

Electronic exchange of indivial case saftey reports between EMA, national competnet authorities, MA H and sponsors of clinical trials in the EEA
Earyl detection and evaluation of possible safety signals

43
Q

Periodic Saftey Udate Report

A

is a report to be prepared by the MA Holder at fixed intervals. Seves to contanly update the benefit risk assessment. Contains all safety data from the time of authorization

44
Q

Time frame for the PSUR?

A

Based on the date of MA: Six monthly report for the first two years fater aprroval
annual reports for the following two years
three-year reports from the date of the renewal of the MA

45
Q

Risk manageent plan include information on

A

a medicine’s saftey profile
how its risk will be prevented or minisied in patients
plans fro studies and other activites to gain more knowlegde about the sefty and efficacy of the medicine
measuring the effectiveness of risk-minimisation measures

46
Q

when the RMP submitted?

A

at the time of applicatin

Drug Regulatory Affairs (15 decks)

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