Workshop on Good Clinical Practices (GCP) and Good Laboratory Practices (GLP)
On 13th and 14th September 2024, the Teerthanker Mahaveer Medical College & Research Centre (TMMCRC) successfully conducted a two-day workshop on Good Clinical Practices (GCP) and Good Laboratory Practices (GLP). Organised by the Medical Education Unit (MEU) of TMMCRC, the workshop aimed to train MD/MS PG Residents in compliance with the National Medical Commission (NMC) mandate for postgraduate residency programmes.
The workshop, essential for PG residents to complete in their second semester, was aligned with the Competency-Based Medical Education (CBME) curriculum introduced by the NMC. Completion of this course is now mandatory for PG residents to appear for their university examinations.
Expert Guidance and Faculty Involvement
The workshop featured renowned resource faculty from PGIMER, Chandigarh, including Dr. Amol N. Patil, Additional Professor of Pharmacology, and Dr. Ashish Kakkar, Associate Professor of Pharmacology. They were joined by in-house experts from TMMCRC, including Prof. (Dr.) Prithpal Singh Matreja, Vice Principal and Head of the Department of Pharmacology, and Dr. Govind Mishra, Assistant Professor of Clinical Pharmacology.
Over the two days, 167 residents were trained on the first day, followed by 170 residents on the second day, ensuring that a large number of postgraduate trainees received comprehensive instruction in GCP and GLP protocols.
Topics Covered in the Workshop
The workshop covered a range of critical topics necessary for PG residents in the field of clinical research and laboratory practices, including:
- ICMR National Ethical Guidelines 2017
- International Council for Harmonization - Good Clinical Practices (ICH-GCP) Guidelines
- Good Laboratory Practices (GLP)
- New Drug and Clinical Trial (NDCT) Rules 2019
- Informed Consent Process
- Protocol Violation, Deviation, and Misconduct
- Serious Adverse Events and Compensation Guidelines
- Documents for Submission to Ethics Committees
Following the detailed training sessions, a post-test was conducted to assess the residents' understanding of the workshop content.
Significance of the Workshop
The GCP and GLP workshop is crucial for ensuring that postgraduate residents are well-versed in ethical guidelines and clinical standards essential for conducting research. Adhering to these guidelines enhances the quality of research and ensures patient safety, which is a key focus of the NMC's curriculum reforms.
The Good Clinical Practices (GCP) workshop empowers medical residents with the skills and knowledge to conduct clinical trials responsibly, while Good Laboratory Practices (GLP) ensures that research conducted in labs adheres to international standards.
Conclusion
The Workshop on Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) at TMMCRC was a significant step towards aligning postgraduate medical education with the latest NMC mandates. By equipping PG residents with essential skills in ethical research and clinical trial management, the workshop ensured that participants were well-prepared to meet both national and international standards in clinical and laboratory practices.
This comprehensive training not only enhances the quality of healthcare research but also underscores TMMCRC's commitment to providing top-tier medical education.