

Advanced PG Diploma in Clinical Research & Pharmacovigilance
- Offered byJAMES LIND INSTITUTE
Advanced PG Diploma in Clinical Research & Pharmacovigilance at JAMES LIND INSTITUTE Overview
Duration | 12 months |
Mode of learning | Online |
Difficulty level | Advanced |
Official Website | Go to Website |
Credential | Certificate |
Advanced PG Diploma in Clinical Research & Pharmacovigilance at JAMES LIND INSTITUTE Highlights
- Earn a certificate after completion of course from James Lind Institute
Advanced PG Diploma in Clinical Research & Pharmacovigilance at JAMES LIND INSTITUTE Course details
The pharmaceutical and biotech industry is revolutionizing in a manner where innovation and pharmacovigilance are not polarized
The business models are maturing to the next level of niche busters and towards a coexistence of novel and the age old blockbuster strategies
Pharmacovigilance forms the backbone of the product life cycle due to a demand created by the need for new drugs and their regulation
Advanced PG Diploma in Clinical Research & Pharmacovigilance at JAMES LIND INSTITUTE Curriculum
MODULE 01: GENERAL INTRODUCTION
MODULE 02: EPIDEMIOLOGY & EVIDENCE BASED MEDICINE
MODULE 03: PHARMACEUTICAL MEDICINE
MODULE 04: THERAPEUTIC AREAS
MODULE 05: ETHICS IN CLINICAL RESEARCH
MODULE 06: ROLES AND RESPONSIBILITIES
MODULE 07: CLINICAL TRIAL PREPARATION
MODULE 08: ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 09: STUDY START-UP
MODULE 10: CLINICAL TRIALS MONITORING
MODULE 11: COMPLIANCE AND AUDITS
MODULE 12: DATA MANAGEMENT AND BIOSTATISTICS
MODULE 13: REGULATORY AFFAIRS IN CLINICAL RESEARCH
MODULE 14: MEDICAL DEVICE TRIALS