Advanced Clinical Research & Pharmacovigilance

Course Overview

This course equips students with practical and theoretical knowledge in Clinical Research, Regulatory Affairs, and Pharmacovigilance—critical components of the pharmaceutical and biotechnology industry.

It focuses on drug development, clinical trial phases, GCP/ICH guidelines, data reporting, and adverse event detection, making graduates job-ready for global healthcare sectors including CROs, Pharma companies, hospitals, and regulatory bodies.

Ideal for students from Pharmacy, Life Sciences, MBBS, BDS, BHMS, and allied medical streams.

Syllabus

• Week Topic
• 1 Overview of Clinical Research & Drug Development Process
• 2 Clinical Trial Phases (I to IV) & Protocol Designing
• 3 Good Clinical Practice (GCP), ICH Guidelines, Schedule Y
• 4 Ethics Committees & Informed Consent Procedures
• 5 Clinical Data Management & Biostatistics (Basics)
• 6 Introduction to Pharmacovigilance – ADRs, Signal Detection
• 7 Risk Management Plans, Case Processing, Global Regulatory Systems
• 8 Hands-on Training, Real-world Case Studies, Final Assessment

Prerequisites

Minimum Qualification: Bachelor's degree in Pharmacy, Life Sciences, Medicine, Nursing, or equivalent.

Recommended Skills:

Basic understanding of Pharmacology

Computer literacy (MS Excel, Google Forms, etc.)

Communication skills (for patient interaction & documentation)