by ClinSkill | Apr 6, 2021 | Medical Writing, Pharmacovigilance
This post is a Guide to Narrative writing that will help you understand the importance and various elements of Narrative writing. Introduction The idea of this guide is to introduce the newcomers to the basic writing principles. This is based on the initial writing...
by ClinSkill | Mar 10, 2021 | Pharmacovigilance
WHO and Safety Reporting In this post we will talk about history, Present program structure, Current work, Guidelines and role of Uppsala Monitoring Centre in relation with WHO and safety reporting for adverse reactions. The WHO International Drug Monitoring Program...
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...
