pharmacovigilance training in hyderabad @PSN Trainings

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
• Pharmacovigilance training in hyderabad 

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. Pharmacovigilance training in india

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.  Pharmacovigilance online training in hyderabad

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 Pharmacovigilance training institute in hyderabad

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)

pharmacovigilance training in india

pharmacovigilance