Pharmacovigilance Training

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PSN Trainings is the Best Pharmacovigilance Online Training institute in Hyderabad,india

Course Description

Introduction to Pharmacovigilance

  • Historical Overview
  • Basic principles of Pharmacovigilance
  • Clinical Development process and Methodologies for Pharmacovigilance

Regulations in Pharmacovigilance

:- Introduction and responsibilities of USFDA, EMA and CDSCO, Drug Regulatory Activities MedDRA, Regulatory Aspects in Pharmacovigilance, Pharmacovigilance Process & Life cycle

Adverse Drug Reactions and Periodic Safety Reports

:- Adverse Events and its types, Different sources of Adverse Events reporting, Four factors for the reportable case, ADR Reporting and timelines/ Causality Assessment of Suspected Adverse Drugs Reactions, Seriousness criteria of adverse event, Periodic Safety Update Reports (PSURs), Development Safety Update Report (DSUR) and their timelines.

Case processing

:- Introduction to Oracle Argus Safety Database, Workflow Configuration, Case Numbering, Different icons used during the case processing and their purpose, Different tabs used in case processing , Minimum requirements for a case Book-in, Case Book-in and Data entry, Case Routing Based on workflow, Case Quality check, Medical review, Duplicate case check or verification.

Narrative Writing

:- Data entry of Individual Case Safety Reports (ICSRs) in to the Argus Safety database, Processing of all incoming cases in order to meet timelines, Writing a detailed medically oriented description of the events in the form of safety narrative, Assessment of seriousness, expectedness/listedness of Adverse Events, Coding of suspect and concomitant drugs using company and WHO-DRUG dictionaries

Signal Detection

:- Definition of signal and type of signals, signal detection and evaluation, source data base for conducting signal detection, statistical methods, Signal Detection Tools, Understanding signals & benefit risk determinations

Brief note on Quality Management of Pharmacovigilance system (QMS-PV)