Pharmacovigilance:-

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

HR-Interview Etiquettes:-

• Communication Skill
• Office etiquettes
• E-mail etiquettes
• Presentation skills and Public speaking
• Interview preparation
• CV preparation
• Mock interviews
• Assessments