Categories

Terms related to periodic safety reports and cumulative safety analysis

Artificial intelligence, machine learning, and digital tools in signal detection, case processing, and PV operations (EMA/FDA 2026).

PV inspections, CAPA, documentation, and readiness for EMA, FDA, CDSCO audits.

Terms related to regulatory inspections and internal audits of pharmacovigilance systems

Terms related to receiving, validating, and prioritizing adverse event reports

Terms related to coding, documenting, and processing adverse event data

CDSCO, PvPI, NCC-PvPI, Indian regulatory requirements, and Mumbai/India-specific PV practice.

GDPR, ICSR masking, anonymization, and data protection in PV (GVP VI Addendum II, CDSCO).

GVP Module XVI Addendum II, E2D(R1), E2B(R3) mandates, and recent ICH/EMA revisions.

Terms related to clinical assessment, medical evaluation, and safety oversight

Terms related to quality control, compliance, and data integrity in pharmacovigilance

RWD, RWE, registries, claims data, and their use in safety evaluation (EMA RWE guidance, FDA 2026).

Cross-regional alignment, IDMP, ICSR standards, and global PV reporting.

Terms related to expedited and periodic safety reporting to regulatory authorities

Terms related to Risk Management Plans and risk minimization activities

Terms related to evaluating severity, seriousness, and causal relationship of adverse events

Advanced signal detection, validation without EMA forms, AI-assisted signals, and risk evaluation methods.

Terms related to detecting, validating, and evaluating safety signals