Post Graduate Diploma in Pharmacovigilance

This is a continuing training / educational program designed to provide a practical knowledge
for the, investigators, clinical research professionals, other pharmaceutical industry professionals,
including sales and marketing personnel and the students of pharmacy and other life science
stream. The program would cover:
 Introduction to Clinical Research & Phases in Clinical Research
 Principles of Good Clinical Practices - ICH GCP
 General Overview of Pharmacovigilance
 Medical Dictionary for Drug Regulatory Activities MedDRA
 Regulatory Aspects in Pharmacovigilance
 Diagnosis And Management of Adverse Drug Reactions
 Medical Evaluation of Adverse Events
 Quality System in Pharmacovigilance
 Expedited Reporting Requirments
 Periodic Safety Update Reports (PSUR,s) For Marketed Drugs (ICH E2C)
 Pharmacovigilance Database And Signal Detection Tools
 Risk Assessment, Evaluation And Management