Exercise 4 (part 2) Flashcards
what is the post-authorization safety study?
any study relating to an authorized medicinal product conducted wit the aim of identifying,characterizing or quantifying a safety, hazard, confirming the safety
aim of the PASS?
aim to evlaute the safety and benefit-risk profile
when is the PASS imposed?
product authorized under exceptional circumstances
who is responsible for assessing the protocols and report of the PASS?
the Pharmacovigilance risk assessment Committee (PRAC)
what are the objectives of the PASS?
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
study design for the
interventional/clinical trial or non-interventional studies
what does the non-interventional studies includes?
database research or review of records
case-control, cross-sectional, cohort studies
primary data collection
what are the observational study design use for?
useful in validate signals from case series, spontaneous report or active surveillance programs
when is the phase IV study required?
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
what is the phase IV studies?
pst marketing studies
what has to be consider during the conduction of the Phase Iv trials?
Design issues Ethics and governanace stakeholder involvement data collection, processing and analysis Funding
what is the aim of the GSAV
Gesetz für mehr sicherheit in der Arzneimittelversorgung?
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
what are the implemented changes in the GSAV law? (part 1)
unannounced inspection of pharmacies and it’s frequency shall be increased
documents check of storage conditions
what are the implemented changes in the GSAV law? (part 2)
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
what are the conserns?
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
what is the aim of the veterinary pharamcovigilance guidance?
ensure safety and efficacy of VMP
How are Adverse events classified?
seriousness into nonserious, serious (life threatening, adverse events)
expected and unexpeted
what is the Spontaneous reporting system?
a system sued for all VMP throughout their lifetime to collect reported advers reactions
what happen in cases where a serious adverse reaction reaction in VMP
the positie benefits-risk balance of the VMP will be reassessed
for what is the Adverse event report use for?
it is the basic unit communication and the first-hand report o an incident
what is the name of the electronic documentation route?
Pharmacovigilance Eudravigilance veterinary database
when should the MAH provide the Periodic safety update reports?
after the determination of the international birth date of the product
what is the international dirth date (IBD)
it is defined as the date of the last day of the same month of the marketing approval of the product
when should the PSUR be submitted?
for the first 2 years for the IBD, the PSUR every six months
3-6 months
annual submssion
