Pharmacovigilance Interview Questions and Answers

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

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

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

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

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

Causality types in pharmacovigilance

• Certain

• Probable/likely

• Possible

• Unlikely

• Conditional

• Unknown

• Alternative

• Concomitant

• Coincidental