What is pharmacovigilance terminology?
Pharmacovigilance A set of activities relating to detection, assessment, understanding. and prevention of adverse effects or any other drug-related. problem. Pharmacovigilance covers the entire life-cycle of a. medicinal product.
What are the types of pharmacovigilance?
There are four important methods in Pharmacovigilance such as,
- Passive surveillance.
- Active surveillance.
- Cohort event monitoring.
- Targeted Clinical Investigations.
What are the types of reports in pharmacovigilance?
Adverse event reporting
- Individual Case Safety Report.
- Activities involved in pharmacovigilance.
- Coding of adverse events.
- Seriousness determination.
- Expedited reporting.
- Clinical trial reporting.
- Spontaneous reporting.
- Aggregate reporting.
What is Dechallenge and rechallenge in pharmacovigilance?
A positive rechallenge – This refers to the AE recurring after restarting the drug. To have this occur, the AE had to have previously disappeared after the dechallenge in order for it to restart. A negative rechallenge – This is the case where the AE does not recur after the drug is restarted.
What is the hierarchy in MedDRA?
The MedDRA dictionary hierarchy is a categorization of medical terminology. The five levels of the dictionary are System Organ Class (SOC), High Level Group Term (HLGT), High Level Term (HLT), Preferred Term (PT), and Lowest Level Term (LLT).
What is CCSI in pharmacovigilance?
Company core safety information (CCSI)
What is KPI in pharmacovigilance?
Pharmacovigilance key performance indicators (PV KPIs) are a set of quantifiable measures that a company uses to gauge its performance over time. These quantifiable measures can be used to indicate how a well a pharmacovigilance system is performing and whether the system is continually improving.
What are the four main components of pharmacovigilance?
Core Capabilities: Pharmacovigilance delivers four primary capabilities to pharmaceutical companies: • Adverse Event Case Management including expedited reporting; • Aggregate Reporting; • Signal Intelligence; and • Risk Management.
What is nullification in pharmacovigilance?
Case Nullification- When case is found to be duplicate of pre-existing case but submissions of reports was done in previous version. In such scenario, the duplicate case cannot be deleted directly but needs nullification.
What is Icsr in pharmacovigilance?
Description: The HL7 Individual Case Safety Report (ICSR) captures information needed to support reporting of adverse events, product problems and consumer complaints associated with the use of FDA regulated products.
What is DSUR in pharmacovigilance?
DSURs are new, internationally-harmonized, safety documents (which became mandatory in European Union member states in September 2011) covering the safety summary of medicinal products during their development or clinical trial phase.
How many HLT is MedDRA?
five levels
There are five levels to the MedDRA hierarchy, arranged from very specific to very general. At the most specific level, called “Lowest Level Terms” (LLTs), there are more than 80,000 terms which parallel how information is communicated.
What is the best glossary for pharmacovigilance?
• CIOMS Living Glossary (first published 2021), which compiles definitions from its reports on various topics in the field of pharmacovigilance. • UMC Glossary of Pharmacovigilance Terms offering definitions of the major concepts and terms used in pharmacovigilance.
What is a pharmacovigilance event?
In Pharmacovigilance an event with a frequency between 1 in 1.000 and 1 in 100. An adverse reaction, the nature or severity of which is not consistent with domestic labelling or market authorization, or expected from characteristics of the drug.
What are the CIOMS guidelines for pharmacovigilance?
The CIOMS is a body set up under WHO and UNESCO. It has developed the following pharmacovigilance guidelines: III – Core data sheets ( CCDS …) Refers to all clinical trials being conducted with the same investigational drug. Systematic study of an investigational medicinal product on human subjects designed to:
What is the CIOMS living glossary?
• CIOMS Living Glossary (first published 2021), which compiles definitions from its reports on various topics in the field of pharmacovigilance. • UMC Glossary of Pharmacovigilance Terms offering definitions of the major concepts and terms used in pharmacovigilance. Adverse event (AE) (largely considered synonymous with adverse experience)