Dr GU Pope Engineering College Interview Questions and Answers

AE stands for Adverse Event, which refers to any untoward medical occurrence in a patient. ADR stands for Adverse Drug Reaction, which specifically refers to a harmful reaction caused by a medication.

• AE is a broader term that encompasses any negative medical event, while ADR specifically relates to medication-induced reactions.

• AE can include events unrelated to medication, such as accidents or natural diseases, while ADR is directly caused by a drug.

• AE can be expected or unex...read more

Causality refers to the relationship between an event (the cause) and a second event (the effect), where the second event is a result of the first.

• Causality is the concept of cause and effect.

• It is used to determine if a drug or medical device caused an adverse event.

• Causality assessment involves evaluating the temporal relationship, dose-response relationship, and alternative explanations for the event.

• Causality can be difficult to establish in complex medical cases.

• Examples...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 the safety of medications post-market approval.

• It includes collecting and analyzing data on adverse drug reactions.

• Pharmacovigilance aims to improve patient safety and minimize risks associated with medication use.

• Examples of pharmacovigilance activities include signal de...read more

AE stands for Adverse Event, which is any undesirable experience or effect associated with the use of a medical product. ADR stands for Adverse Drug Reaction, which is a type of AE caused by a medication.

• AE refers to any negative experience or effect associated with the use of a medical product, regardless of whether it is caused by the product or not.

• ADR specifically refers to negative experiences or effects caused by a medication.

• Both AE and ADR are important to monitor and...read more

ADR is a harmful reaction caused by a drug, while AE is any untoward medical occurrence.

• ADR is a known and expected harmful reaction caused by a drug.

• AE is any untoward medical occurrence that may or may not be caused by a drug.

• ADR is listed on the drug's label as a potential side effect.

• AE can include symptoms, signs, diseases, or worsening of pre-existing conditions.

• Example of ADR: nausea and vomiting from chemotherapy drugs.

• Example of AE: headache or dizziness after taking...read more

MedDRA stands for Medical Dictionary for Regulatory Activities. It is a standardized medical terminology used for coding adverse event information.

• MedDRA is used for classifying and coding adverse events in clinical trials and post-marketing surveillance.

• It helps in standardizing the terminology used for reporting adverse events in drug safety.

• MedDRA is maintained and updated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Huma...read more