Module I Pharmaco-vigilance Introduction 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 Methodologies for Pharmacovigilance 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 Internal audit of pharmacovigilance activities of a company Management of Pharmacovigilance Data Risk Management in Pharmacovigilance Data management & software solutions Effective communication in pharmacovigilance Pharmacovigilance in special situations Pharmacovigilance capacity building