pharmacovigilance course Intermediate Level by BITECH

Module 1 Introduction of Pharmacovigilance
Topic 1 Overview Of Pharmacovigilance
Topic 2 Standard Terms And Terminology In Pharmacovigilance

Module 2 Medical Evaluation Of Adverse Events In Pharmacovigilance
Topic -1 Adverse Event Reporting System And Form
Topic 2 Diagnosis And Managements Of ADRs
Topic 3 Medical Evaluation Of AE

Module 3 Case Processing
Topic 1 Global Perspective Of Pharmacovigilance
Topic 2 Single Case Processing
Topic 3 Case Narrative Writing

Module 4 Pharmacovigilance Reporting Database , Signal Detection , Managements And Risk Assessments & Evaluation
Topic 1 Quality System In PV
Topic -2 Expedited Reporting Criteria
Topic -3 PSUR & PBRER
Topic 4 PV Database And Signal Detection
Topic 5 Risk Assessments & Managements

Module 5 Medical Dictionary For Regulatory Activities medDRA
Topic 1 medDRA

Module 6 PV laws And Guideline
Topic 1 Regulatory Guideline & Laws In PV
Topic 2 SOPS In PV
Topic 3 PV Auditing And Inspection
Topic 4 Regulatory Aspects In PV