Post Graduate Diploma in Clinical Trials Management (For Medical Professionals Only)

Program Detail: Clinical Research Introduction & Terminology Introduction to Pharmaceutical Industry & Global Challenges Global Clinical Research Environment & Opportunities Principles of Pharmacology & Drug Discovery & Development ICH GCP Principles, Indian GCP & Schedule Y Regulatory Affairs Roles & Responsibilities of Key Stakeholders Ethics in Clinical Research Preparations & Planning for Clinical Trials Essential Documentation in Clinical Research & Regulatory Submissions Clinical Trials Project Planning & Management Study Start up Process Clinical Monitoring Essentials & Medical Monitoring Compliance, Auditing & Quality Control in Clinical Research Clinical Data Management, Biostatistics, Analysis & Reporting Pharmacovigilance Bioavailability and Bioequivalence Studies Management of Cancer Clinical Trials Organizational Behavior & Human Resource Management Fundamentals of Financial Management