Pharmacovigilance Interview Questions
Please note, final edits are pending. Pharmacovigilance/ D rug safety : As per WHO, Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. ICH: The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ( ICH ) PSUR: Periodic Safety Update Reports ( PSUR ) SUSAR: Suspected Unexpected Serious Adverse Reactions ( SUSAR ). ADR (Adverse Drug Reaction): What is an adverse drug reaction? An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use, which is suspected to be related to the drug. The reaction may be a known side effect of the drug or it may be new and previously unrecognised. Is the reaction an ADR or an ...