Maharashtra Navik Kamgar Sanghatana Interview Questions and Answers

ASR stands for Adverse Event from Spontaneous Reporting while AE stands for Adverse Event.

• ASR is a type of adverse event that is reported spontaneously by patients or healthcare professionals.

• AE is any undesirable experience associated with the use of a medical product, regardless of whether it is related to the product.

• ASR is usually reported to regulatory authorities while AE can be reported to the manufacturer or regulatory authorities.

• ASR is often used in pharmacovigilanc...read more

Labelling criteria and umbrella terms are important for drug safety.

• Labelling criteria are the guidelines that must be followed when creating drug labels.

• Umbrella terms are broad categories used to group together similar adverse reactions.

• Both labelling criteria and umbrella terms are important for ensuring drug safety and proper communication of risks to patients and healthcare providers.

• Examples of umbrella terms include 'cardiac disorders' or 'gastrointestinal disorders'.

E2 and E3 files are both regulatory submission formats used in drug safety, but they differ in their content and purpose.

• E2 files are used for clinical trial data submissions, while E3 files are used for post-marketing safety reports.

• E2 files contain information on study protocols, patient demographics, adverse events, and clinical outcomes.

• E3 files contain information on individual case safety reports (ICSRs), including details of adverse events, patient demographics, and dr...read more

Nullifying a case means declaring it invalid or void.

• Nullifying a case is done when there is evidence that the reported adverse event is not related to the drug being studied.

• Cases can be nullified if there is insufficient information or if the event is determined to be unrelated to the drug's mechanism of action.

• Nullification may also occur if the reported event is a known side effect of the drug and does not require further investigation.

• Examples of nullifying a case includ...read more

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 of drugs

• It aims to identify and prevent adverse drug reactions

• It involves collecting and analyzing data from various sources such as clinical trials, spontaneous reports, and literature

• Pharmacovigilance plays a crucial role in ensuring patient sa...read more