Pharmacovigilance (PvPI & Safety)

A noxious and unintended response to a medicinal product where a reasonable causal relationship is suspected.

Medical college, tertiary hospital, or clinical institution recognized by IPC-PvPI to collect and validate spontaneous ADR reports.

Any untoward medical occurrence in a patient administered a drug product, not necessarily having a causal relationship.

Standard international paper/PDF reporting format established by Council for International Organizations of Medical Sciences for reporting single ADR cases.

International recommendations on drug safety, risk management, and clinical trial ethics established by CIOMS.

Standardized grading scale (NCI) for adverse events in oncology: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).

Withdrawal or dose reduction of suspected drug to observe whether adverse clinical event abates or resolves.

Set of measures drawn up to facilitate the performance of pharmacovigilance across the European Union, ensuring timely detection, assessment, and prevention of adverse effects.

National program tracking adverse reactions and incidents associated with blood transfusion and blood product administration.

Designated national safety officer acting as single point of contact for local regulatory authorities in a specific country.

National safety surveillance program monitoring adverse events associated with medical devices and in vitro diagnostics in India.

Medical Dictionary for Regulatory Activities; standardized international medical terminology dictionary.

Standardized international medical terminology organized into 5 hierarchical levels: System Organ Class (SOC), HLGT, HLT, Preferred Term (PT), and Lowest Level Term (LLT).

Third level in MedDRA hierarchy grouping related High Level Terms under a common physiological or clinical concept.

Most granular entry in MedDRA reflecting verbatim clinical reporter terminology and colloquial medical synonyms.

Distinct medical descriptor in MedDRA representing a single medical concept for symptom, sign, disease, or diagnosis.

Standardized 10-question questionnaire assessing causality between adverse clinical event and drug: scores >= 9 Definite, 5-8 Probable, 1-4 Possible.

Science and activities relating to the detection, assessment, understanding, and prevention of adverse drug effects.

National surveillance program monitoring Adverse Drug Reactions (ADRs) reported by healthcare professionals, hospitals, and pharmaceutical marketing authorization holders.

Nationwide drug safety monitoring program initiated in 2010 to collect, analyze, and communicate adverse drug reactions in Indian population.

Detailed legal dossier describing the global pharmacovigilance organizational structure, databases, SOPs, and performance of marketing authorization holder.

An appropriately qualified individual in the European Union who is permanently and continuously at the disposal of the marketing authorization holder for pharmacovigilance oversight.

Re-administration of suspected drug to a patient who previously experienced an adverse reaction following dechallenge.

Any untoward medical occurrence that at any dose results in death, life-threatening situation, hospitalization, disability, or congenital anomaly.

Any untoward medical occurrence at any dose resulting in: Death, Life-threatening event, Inpatient hospitalization or prolongation, Persistent disability, or Congenital anomaly.

Systematic search in pharmacovigilance databases for safety signals indicating new or altered adverse drug risks.

Statistical method comparing observed adverse reaction frequency for a drug against expected database background frequency.

Routine statistical analysis of spontaneous safety databases to identify new previously uncharacterized drug safety hazards.

Standardized bilingual reporting form for clinicians and healthcare professionals capturing patient demographics, suspect drug, and reaction.

Serious adverse reaction occurring in a clinical trial whose nature or severity is not consistent with the reference safety information (Investigator’s Brochure).