02/12/2014
Pharmacoviglance Training with Placement Assistance.now in GUNTUR &VIJAYAWADA. contact :0863-6450999
Pharmacovigilance Training / Course/ Training Institute:-
Module I Pharmacovigilance
Introduction
Historical Overview
Basic principles of Pharmacovigilance in Clinical Trials
Methodologies for Pharmacovigilance
Module II Regulations in Pharmacovigilance in Clinical Research
FDA and EU perspectives
Drug Regulatory Activities MedDRA
Regulatory Aspects in Pharmacovigilance
EudraVigilance
Regulations in Pharmacovigilance in Clinical Research
Module III Adverse Drug Reactions and Safety Reports
ADR Reporting
Causality Assessment of Suspected Adverse Drugs Reactions
Periodic Safety Update Reports (PSURs) For Marketed Drugs (ICH E2C)
Expedited Reporting Requirements
Individual case safety reports
Periodic safety update reports
Electronic safety reporting
WHO & safety monitoring
Module IV Signal Analysis
Definition of signal and type of signal
Conducting signal detection in clinical and post marketing surveillance
Defining signal in relation to risk/benefit
Signal generation to decision making
Signal Detection Tools
Understanding signals & benefit risk determinations
Module V Compliance to Clinical Safety and Pharmacovigilance Regulations
Review of benefit-risk assessments and management
Scope of Pharmacovigilance inspection and conduct of inspection
Internal audit of pharmacovigilance activities of a company
Pharmacovigilance inspection reports
Pharmacovigilance compliance and inspection
Quality System in Pharmacovigilance : Good Practices, SOPs, Preparation for Audits & Inspections
Scope of Pharmacovigilance inspection and conduct of inspection
Internal audit of pharmacovigilance activities of a company
Key Functionalities of the Adverse Event Systems
Quality System in Pharmacovigilance : Good Practices, SOPs, Preparation for Audits & Inspections
Module VI Pharmacovigilance Management and Importance
Pharmacovigilance Database
Setting up a Pharmacovigilance Centre in Industry
Management of Pharmacovigilance Data
Risk Management in Pharmacovigilance
Data management & software solutions
Effective communication in pharmacovigilance
Pharmacovigilance in special situations
Pharmacovigilance capacity building
Training Duration (Classroom/Online): 3-Months/2-Months
Training Fee: 20K
