. What is Pharmacovigilance? Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines. 2. What is the minimum criterion required for a valid case? a. An identifiable reporter b. An identifiable identifiable patient c. A suspect product d. An adverse drug event 3. What is an Adverse Drug Event ADE!? An" unto#ard medical occurrence in a patient or clinical investigation sub$ect administered a pharmaceutical product and #hich does not necessaril" have to have a causal relationship #ith this treatment. %. What is an Adverse Drug &eaction AD&!? An adverse drug reaction is a 'response to a drug #hich is no(ious and unintended and #hich occurs at doses normall" used in man for proph"la(is, diagnosis, or therap" of disease or for the modification of ph"siologic function.) *ote that there is a causal lin+ bet#een a drug and an adverse drug reaction. n sum, an adverse drug reaction is harm directl" caused b" the drug at normal doses, during normal use. -. What is the difference bet#een an ADE and AD&? here ma" not be a causal relationship bet#een a drug and an ADE, #hereas, there is a causal lin+ bet#een a drug and an adverse drug reaction. /. When do "ou consider an event to be serious? f an event is associated #ith an" one o ne of the follo#ing, it is considered to be serious a. Death b. 0ife threatening c. 1ospitaliation or prolongation of hospitaliation. d. ongenital anomal" e. Disabilit" f. 4edicall" significant 5. *ame the regulator" bodies in 67A, 68, 9apan and ndia? 67A: 6nited 7tates ;ood and drug administration 67;DA!. 68: European 4edicines Agenc" E4EA!. 9apan: 4inistr" of 1ealth, 0abour and Welfare Welfare 410W!. 410W!. ndia: entral Drugs 7tandard ontrol olume A? >olume A brings together general guidance gu idance on the requirements, procedures, roles and activities in the field of pharmacovigilance, for both 4ar+eting Authorisation Authorisation 1olders 4A1! and ompetent Authorities of medicinal products for human use@ it incorporates international agreements reached #ithin the frame#or+ of the nternational onference on 1armonisation 1!. >olume A is presented in four parts: Part deals #ith uidelines for 4ar+eting Authorisation 1olders@ Part deals #ith uidelines uide lines for ompetent Authorities and the Agenc"@ Part provides the uidelines for the electronic e(change of pharmacovigilance in the E6 Part > provides uidelines on pharmacovigilance communication.
. When do "ou consider a case to be medicall" confirmed? A case is considered to be medicall" confirmed if it contains at least one event confirmed or reported b" an 1P 1ealth are Professional! *ote: 1P can be a ph"sician, nurse, pharmacist, coroner or ps"chologist onl" in erman"!. BC. What do "ou mean b" causalit"? ausalit" is the relationship bet#een a set of factors. n Pharmacovigilance, causalit" is the relationship bet#een the suspect product and the adverse drug event. . What are the ob$ectives in Pharmacovigilance? A. 6nderstanding the concepts of AD&, 4edical Errors, Public 1ealth 7ignificance, &egulator" nterventions, AD& 4onitoring schemes. . What are the t"pes of Pharmacovigilance P>!? A. #o t"pes. B. Active P> and 2.Passive P> Active P>: Active or proactive! safet" surveillance means that active measures are ta+en to detect adverse events. his is managed b" active follo#up after treatment and the events ma" be detected b" as+ing patients directl" or screening patient records. he most comprehensive method is cohort event monitoring E4! Passive P>: Passive surveillance means that no active measures are ta+ en to loo+ for adverse effects other than the encouragement of health p rofessionals and others to report safet" concerns. &eporting is dependent on the initiative and motivation of the potential reporters. his is the most common form of pharmacovigilance. t is commonl" referred to as 'spontaneous) or 'voluntar") reporting. . What are the due dates for safet" reporting? A. 7afet" reporting due dates are 5da"s for *D &eporting and B- da "s for *DA &eporting . What are Data assessments in Pharmacovigilance? A. Data assessments are ndividual case report assessment Aggregated assessment and interpretation 7ignal detection nteractions and ris+ factors 7erial stud" ;requenc" Estimation ;ind &epl" uote Enter Keyw ords
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