by ClinSkill | Feb 15, 2021 | Pharmacovigilance
Overview of MedDRA In this post we will learn about the Overview of MedDRA, its history and origin, MedDRA subscriptions, contents and uses of MedDRA. Introduction to MedDRA MedDRA is a registered trademark belonging to the International Federation of Pharmaceutical...
by ClinSkill | Jan 16, 2021 | Pharmacovigilance
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...
by ClinSkill | Jan 13, 2021 | 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...
by ClinSkill | Jan 3, 2021 | Pharmacovigilance
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...
by ClinSkill | Nov 30, 2020 | 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...
by ClinSkill | Nov 27, 2020 | Pharmacovigilance
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...
