Program Details:

Semester 1

Group 1 :Clinical Research Introduction

Group 2: Principles of Pharmacology & Drug Discovery & Development

Group 3 :Roles & Responsibilities of Key Stakeholders

Group 4: Preparations & Planning for Clinical Trials

Group 5: Essential Documentation in Clinical Research & Regulatory Submissions

Group 6: Clinical Trials Project Planning & Management

Group 7: Study Start Up Process

Group 8: Clinical Monitoring Essentials

Group 9: Compliance, Auditing & Quality Control in Clinical Research

Group 10: Clinical Data Management, Biostatistics, Analysis & Reporting

Semester 2

Group 11 General Overview of Pharmacovigilance

Group 12 Medical Dictionary for Drug Regulatory Activities MedDRA

Group 13 Regulatory Aspects in Pharmacovigilance

Group 14 Diagnosis And Management of Adverse Drug Reactions

Group 15 Medical Evaluation of Adverse Events

Group 16 Quality System in Pharmacovigilance

Group 17 Expedited Reporting Requirements

Group 18 Periodic Safety Update Reports (PSURs) For Marketed Drugs (ICH E2C)

Group 19 Pharmacovigilance Database And Signal Detection Tools

Group 20 Risk Assessment, Evaluation And Management

Group 21 EudraVigilance

Group 22 Suspected Unexpected Serious Adverse Reaction (SUSAR) Reporting