Published on: March 1, 2025
The Department of Clinical Research, Himalayan Institute of Medical Sciences at Swami Rama Himalayan University, hosted an insightful guest lecture on February 5, 2025, aimed at familiarizing students with critical global ethical and regulatory frameworks in clinical research. The session was conducted by Dr. Bindu Dey and held at the department’s premises with the participation of 20 M.Sc. Clinical Research students.
Dr. Dey provided a detailed introduction to major international and national guidelines that uphold the integrity, safety, and quality of clinical research and pharmaceutical development. The session began with an overview of the International Council for Harmonisation (ICH), which harmonizes technical standards globally to ensure pharmaceutical product safety, efficacy, and quality.
She further elaborated on Good Clinical Practice (GCP), a globally accepted ethical and scientific quality standard for conducting clinical trials involving human subjects. GCP ensures participant protection and the credibility of trial data. Complementing this, Dr. Dey discussed Good Laboratory Practice (GLP), which focuses on the integrity and consistency of non-clinical safety studies, and Good Manufacturing Practice (GMP), which governs the quality of production processes to ensure safe and effective pharmaceutical products.
The lecture also covered the roles of national and regional regulatory authorities such as the Central Drugs Standard Control Organization (CDSCO), the Drug Controller General of India (DCGI), and the European Union (EU) regulatory systems. Dr. Dey introduced students to the Code of Federal Regulations (CFR) from the U.S., highlighting its broad regulatory scope and relevance to clinical and pharmaceutical practices.
Throughout the session, students gained valuable insights into how these ethical guidelines and frameworks collectively safeguard public health and uphold scientific credibility in clinical and pharmaceutical research. Dr. Bindu Dey’s engaging approach and in-depth knowledge were appreciated by attendees, making the session both informative and impactful.
