by ClinSkill | Jan 20, 2023 | Pharmacovigilance
Individual Case Safety Reports In this post we shall discuss about Individual Case Safety Reports (ICSRs). in this post we will cover the following topics: Introduction This post includes data elements of case safety reports for both pre and post approval periods and...
by ClinSkill | Jul 23, 2022 | Empirica Signal, Pharmacovigilance
Oracle Empirica Signal upgraded to 9.2 We have been offering Oracle Empirica Signal 7.3.3 software access as part of our Pharmacovigilance Signal Detection courses, as well as through our Oracle Empirica Signal – software access subscription service. This has...
by ClinSkill | May 2, 2022 | Argus Safety, Pharmacovigilance
Oracle Argus Safety upgraded to 8.2.3 We have been offering Oracle Argus Safety 8.1.1 software access as part of our Pharmacovigilance and Argus Safety courses, as well as through our Oracle Argus Safety – software access subscription service. This has allowed...
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...