Basic concepts of Pharmacovigilance, like
PSUR, ICSR, AE reporting time lines, ICH guidelines and local laws, Investigators qualification, QPPV, case Narratives, Different PV- Algorithms like ARGUS, Oracle, etc.. , Dechallenge, Rechallenge, Different regulatory authorities, USFDA, CDSCO, EMEA, causality assessment, MedDRA and hierarchy, Signal detection, Different reporting timeframes from Investigators to sponsor and to RA.
