This interactive session will provide a comprehensive introduction to ICH-GCP (International Council for Harmonisation – Good Clinical Practice) and its critical role in clinical research. Through practical examples and real-world scenarios, participants will gain an understanding of ethical principles, participant safety, informed consent procedures, clinical trial conduct, and data integrity requirements.

The session will focus on bridging theoretical concepts with industry-oriented applications, helping learners understand how clinical trials are conducted according to international standards and regulatory expectations.

Topics Covered:

• Overview of Clinical Research and Trial Phases
• Introduction to ICH-GCP Guidelines
• Ethics and Protection of Participant Rights
• Informed Consent Process and Documentation
• Roles and Responsibilities of Clinical Research Professionals
• Study Protocols and Regulatory Compliance
• ALCOAs and Data Integrity Principles
• Good Documentation Practices (GDP) in Clinical Research
• Common Challenges and Best Practices in Clinical Trials
• Career Opportunities in Clinical Research

 

About the Speaker

Dr. Shafali Nagpal (BDS) is a healthcare professional with a keen interest in clinical research and Good Clinical Practice (GCP). In this session, she will provide practical insights into ICH-GCP guidelines, ethical principles, participant safety, documentation standards, and regulatory compliance, helping participants build a strong foundation in clinical research.

This session is ideal for medical students, pharmacy students, life science graduates, interns, clinical research aspirants, and healthcare professionals who want to build a strong foundation in clinical research and understand the practical implementation of Good Clinical Practice standards in the pharmaceutical and healthcare industry.