Exercise 4 (part 2)

Question 1

what is the post-authorization safety study?

Answer 1

any study relating to an authorized medicinal product conducted wit the aim of identifying,characterizing or quantifying a safety, hazard, confirming the safety

Question 2

aim of the PASS?

Answer 2

aim to evlaute the safety and benefit-risk profile

Question 3

when is the PASS imposed?

Answer 3

product authorized under exceptional circumstances

Question 4

who is responsible for assessing the protocols and report of the PASS?

Answer 4

the Pharmacovigilance risk assessment Committee (PRAC)

Question 5

what are the objectives of the PASS?

Answer 5

Clinical and operational feasibility with ethical and legal considerations duplication of work
identification of risk and quantification potential and ensure highe safety requirements
support eveidence of the risk absense and minimization

Question 6

study design for the

Answer 6

interventional/clinical trial or non-interventional studies

Question 7

what does the non-interventional studies includes?

Answer 7

database research or review of records
case-control, cross-sectional, cohort studies
primary data collection

Question 8

what are the observational study design use for?

Answer 8

useful in validate signals from case series, spontaneous report or active surveillance programs

Question 9

when is the phase IV study required?

Answer 9

To assess a known serious risk related to the use of the drug
to assess signals of serious risk related to the use of the drug
to identify an unexpected serious risk when available data indicate the ptential for a serious risk

Question 10

what is the phase IV studies?

Answer 10

pst marketing studies

Question 11

what has to be consider during the conduction of the Phase Iv trials?

Answer 11

Design issues
Ethics and governanace
stakeholder involvement
data collection, processing and analysis
Funding

Question 12

what is the aim of the GSAV

Gesetz für mehr sicherheit in der Arzneimittelversorgung?

Answer 12

increase safety and quality of some drug products or manufacturing processes
secure the drug supply and to make it easier for patients to get acces to needed drug products

Question 13

what are the implemented changes in the GSAV law? (part 1)

Answer 13

unannounced inspection of pharmacies and it’s frequency shall be increased
documents check of storage conditions

Question 14

what are the implemented changes in the GSAV law? (part 2)

Answer 14

Onyl physicians are allowed to manufacture prescription only medicine, persons are excluded
handing out of prescription only drug products when the diagonsis from a physician was made remotely
Pharmacies are allow to distribute drug products from hemophilia
patient taking cannabis need only one approvement from the health insurance to receive the product

Question 15

what are the conserns?

Answer 15

Pharmacy-level substitution leading to no patients or physicinas involvment
siginificant drop in the price of medicines
no improve security of supply product chain
lacks fruther steps to strength patients right

Question 16

what is the aim of the veterinary pharamcovigilance guidance?

Answer 16

ensure safety and efficacy of VMP

Question 17

How are Adverse events classified?

Answer 17

seriousness into nonserious, serious (life threatening, adverse events)
expected and unexpeted

Question 18

what is the Spontaneous reporting system?

Answer 18

a system sued for all VMP throughout their lifetime to collect reported advers reactions

Question 19

what happen in cases where a serious adverse reaction reaction in VMP

Answer 19

the positie benefits-risk balance of the VMP will be reassessed

Question 20

for what is the Adverse event report use for?

Answer 20

it is the basic unit communication and the first-hand report o an incident

Question 21

what is the name of the electronic documentation route?

Answer 21

Pharmacovigilance Eudravigilance veterinary database

Question 22

when should the MAH provide the Periodic safety update reports?

Answer 22

after the determination of the international birth date of the product

Question 23

what is the international dirth date (IBD)

Answer 23

it is defined as the date of the last day of the same month of the marketing approval of the product

Question 24

when should the PSUR be submitted?

Answer 24

for the first 2 years for the IBD, the PSUR every six months
3-6 months
annual submssion

Question 25

what are the other important parts of the PSUR?

Answer 25

lack of efficacy, adverse reaction report related to off.lable use
potential environmental problems and issues regading the Maximum Resuide limits

Question 26

what are the particularities of the veterinary pharmacovigilance?

Answer 26

Reporting of humans adverse reactions to VMP
Reporting lack of expected efficacy
Multiple species
off.lable use
inventigation of the validity of the withdrawal period
potential environmental problems

Question 27

Multiple species system?

Answer 27

two categories of animals, food producing and non-food producing anaimals, difference in anantomy, metabolim or enzyme patterns

Question 28

what are the responsibility qualified Persons?

Answer 28

ppreparing and submitting documents to the competent authorities

Question 29

Which documents should the QP submit

Answer 29

Serious adverse reaction reports in anaimals
Adverse reaction report in humans
Periodic safety Update report

Question 30

what is the main task of the Graduated plan officer?

Answer 30

responsible for veterinary products in the Federal Office of consumer protection and Food safety
batch or product recalls
GPO is personally liable