Pharmacovigilance training in hyd - Hyderabad

Pharmacovigilance Course:-


Class Room:
Training Fee & Duration : 20K & 3 MonthsOnline
Training Fee & Duration : 23K & 3 Months

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

Oracle Argus Software—Live

HR-Interview Etiquettes:-
·Communication Skill
·Office etiquettes
·E-mail etiquettes
·Presentation skills and Public speaking
·Interview preparation
·CV preparation
·Mock interviews
·Assessments