Qualified Person for Pharmacovigilance (QPPV)

Qualified Person for Pharmacovigilance (QPPV)

Qualified Person for Pharmacovigilance (QPPV) This post will give you a brief understanding about who a QPPV is and what his roles ad responsibilities are. Introduction – Qualified Person for Pharmacovigilance (QPPV) In the European Union, the Qualified Person...
Audits and Inspections in Pharmacovigilance

Audits and Inspections in Pharmacovigilance

Audits and Inspections in Pharmacovigilance Overview – Audits and Inspections in Pharmacovigilance This post describes how pharmacovigilance audits are performed, from the audit planning to writing an audit report. It gives an overview of several aspects of...
Post Marketing Surveillance

Post Marketing Surveillance

Post Marketing Surveillance Introduction to Post Marketing Surveillance The fundamental importance of safety and efficacy assessment throughout the drug development process has been emphasized many times. Efficacy is also considered throughout the drug development...
Signal Detection in Pharmacovigilance

Signal Detection in Pharmacovigilance

Signal Detection in Pharmacovigilance Signal detection in Pharmacovigilance involves looking at the adverse reaction data for patterns that suggest new safety information and specifically whether the new information changes the benefit to risk ratio associated with...
Pharmacovigilance for Vaccines

Pharmacovigilance for Vaccines

Pharmacovigilance for Vaccines Pharmacovigilance for Vaccines, also known as Vaccine vigilance, is defined as the science and activities relating to the detection, assessment, understanding, prevention, and communication of adverse events following immunization, or of...
History of Pharmacovigilance

History of Pharmacovigilance

In this post we discuss about the History of Pharmacovigilance, its definition and the events that led to the need for pharmacovigilance. Old Definition of Pharmacovigilance Pharmacovigilance is the detection in the community of drug effects, usually adverse....