Pharmacovigilance Training in Hyderabad
PSN Trainings is the Best Pharmacovigilance Online Training institute in Hyderabad,india
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.
:- 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.
:- 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
:- 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)