Pharmacovigilance

Pharmacovigilance Interview Questions and Answers

Updated 9 Mar 2022
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Q1. What is adverse drug reaction and what is adverse drug event

Ans.

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 ?

Ans.

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.

Ans.

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

Ans.

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

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Q5. Drug used as ANTIEPLIPTIC drug

Ans.

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

Ans.

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

Ans.

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 ?

Ans.

Causality types in pharmacovigilance

  • Certain

  • Probable/likely

  • Possible

  • Unlikely

  • Conditional

  • Unknown

  • Alternative

  • Concomitant

  • Coincidental

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