Pharmacovigilance (Drug Safety Webinar)

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.

 http://www.theapprentiice.com/course.php?courseid=89

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