Pharmacovigilance
Pharmacovigilance Interview Questions and Answers
Q1. What is adverse drug reaction and what is adverse drug event
Adverse drug reaction is a harmful or unintended response to a medication, while adverse drug event is any untoward medical occurrence related to drug use.
Adverse drug reaction is a type of adverse drug event
Adverse drug reactions are usually dose-dependent
Adverse drug events can include medication errors, allergic reactions, and drug interactions
Adverse drug events can occur even when a medication is used correctly
Adverse drug events can range from mild to severe, and can ev...read more
Q2. 1) what is volume 9A ?
Volume 9A is a guidance document issued by the European Medicines Agency (EMA) for the collection, management, and submission of pharmacovigilance data.
Volume 9A provides instructions on the reporting of adverse drug reactions (ADRs) and other safety-related information.
It outlines the requirements for the electronic submission of pharmacovigilance data to the EMA.
Volume 9A also includes guidelines on the use of the EudraVigilance database for the monitoring and analysis of s...read more
Q3. Types of pharmacovigillance,Banned drugs Names and reason find out from following options.
Types of pharmacovigilance and banned drugs with reasons.
Types of pharmacovigilance include spontaneous reporting, intensive monitoring, targeted monitoring, and cohort event monitoring.
Banned drugs include thalidomide, phenylpropanolamine, and rofecoxib due to severe adverse effects.
Thalidomide was banned due to causing birth defects, phenylpropanolamine due to causing strokes, and rofecoxib due to causing heart attacks.
Other drugs may be banned due to safety concerns or lac...read more
Q4. What is clinical trials What is pharmacovigilance What is ICSR what are the clinical trial phases Process of NDA and INDA what is PSUR What is Antihistamines What is the gastric secretion drugs
This interview covers topics related to clinical trials, pharmacovigilance, ICSR, clinical trial phases, NDA and INDA process, PSUR, antihistamines, and gastric secretion drugs.
Clinical trials are research studies that test the safety and efficacy of new drugs or treatments on humans.
Pharmacovigilance is the science of monitoring, detecting, assessing, and preventing adverse effects of drugs.
ICSR stands for Individual Case Safety Report, which is a report of an adverse event ...read more
Q5. Drug used as ANTIEPLIPTIC drug
Antiepileptic drugs are used to treat and prevent seizures in individuals with epilepsy.
Antiepileptic drugs are also known as anticonvulsant drugs.
These drugs work by suppressing the excessive electrical activity in the brain that leads to seizures.
Examples of antiepileptic drugs include phenytoin, carbamazepine, valproic acid, and lamotrigine.
Q6. Classification of Antidiabetic drugs
Antidiabetic drugs can be classified into several categories based on their mechanism of action.
Biguanides (e.g. Metformin) - decrease glucose production in the liver
Sulfonylureas (e.g. Glipizide) - stimulate insulin secretion from the pancreas
Meglitinides (e.g. Repaglinide) - stimulate insulin secretion from the pancreas
Thiazolidinediones (e.g. Pioglitazone) - increase insulin sensitivity in muscle and fat cells
DPP-4 inhibitors (e.g. Sitagliptin) - increase insulin secretion...read more
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Q7. What is pharmacovigilence
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
Pharmacovigilance involves monitoring and evaluating the safety and efficacy of drugs.
It aims to identify and prevent adverse drug reactions (ADRs) and other drug-related problems.
Pharmacovigilance activities include collecting and analyzing data on drug safety, reporting ADRs, and communicating safety inform...read more
Q8. Types of causality ?
Causality types in pharmacovigilance
Certain
Probable/likely
Possible
Unlikely
Conditional
Unknown
Alternative
Concomitant
Coincidental
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