E-Learning Course Curriculum of Pharmacovigilance

Module I Pharmaco-vigilance
- 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

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