This course explains the basics of the principles of drug safety, what exactly term “Pharmacovigilance” (PVG) is and how to handle clinical safety information of patients in clinical research scenario. If you are involved in any aspect of pharmacovigilance, our course will help you comply with the regulatory laws. The course provides insight into the responsibility of various people involved in clinical trials in view of pharmacovigilance.
Course Curriculum: Instructor Lead Sessions:-
Demo session: Demo and Webex Set Up
Session 1: Introduction and basics of PVG : 2 hours
Session 2: What is AE/SAE? And Drug Dictionary : 2 hours & quiz
Session 3: Regulatory Guidelines & Laws in Pharmacovigilance ; ISCR: 3 hours
Session 4: Management of Adverse Events : 2 hours
Session 5: AE/ADR Reporting System : 2 hours + workshop
Session 6: Source Data Verification of SAE/AE/CM/Med Hist - SAE reconciliation process : 2 hours + workshop
Session 7: Expedited Safety Reporting and reconciliation: 2 hours + workshop
Session 8 : Overview of PVG software& summary: 2 hours practical + summary
Course Fees an be paid directly though the link below.
Once you open the link, Click on “Start Training” and it will take you to the payment gateway. As soon as you make the payment, you will be considered as enrolled for the course. You will be contacted shortly for the upcoming session thereafter.
|Course Details||Duration (hours)|
Have A Question?
This site is best viewed in 1366*768 resolution and IE 9.x or higher, Mozilla Firefox® 10.x or higher, Safari 5.1 or higher, Chrome 18 or higher, or equivalent browser software.