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In a pivotal move to enhance the ethical and scientific rigor of clinical research in India, a five-day national workshop titled “Regulatory and Operational Aspects of Clinical Trials” will be held between September 15 and September 19 at Kalyani Nagar, Pune.
Jointly organized by the KEM Hospital & Research Centre and the ICMR-National Institute of Translational Virology & AIDS Research (formerly ICMR-National AIDS Research Institute), this workshop is sponsored by the Department of Health Research (DHR) and the Indian Council of Medical Research (ICMR).
Bringing together a cohort of 25 experienced clinical researchers, the workshop is a landmark initiative focused on strengthening the country’s capacity in ethical, scientific, and regulatory dimensions of clinical trials—particularly vital in the age of rapid biomedical innovation and global health challenges.
The week-long program is meticulously designed to provide hands-on exposure to all critical aspects of clinical trial conduct. Topics range from regulatory frameworks and early phase drug development to submissions to regulatory authorities, such as the Central Drugs Standard Control Organization (CDSCO).
Through a series of expert-led sessions, interactive discussions, and mock exercises, participants will explore real-world challenges in planning, implementing, and overseeing clinical trials. A visit to a functioning clinical trial site is also scheduled, offering a rare behind-the-scenes look into the operational backbone of clinical research.
With increasing public scrutiny and global attention on trial transparency, the workshop emphasizes informed consent, data integrity, patient safety, and the role of Institutional Ethics Committees. Faculty members—veterans in regulatory science and clinical trial oversight—will guide participants through case studies and mock reviews, enabling a deeper understanding of both the theoretical and operational ethics of clinical trials.
The workshop is tailored for clinical researchers with 2–3 years of experience, ensuring that participants can immediately apply their learnings to ongoing or upcoming research projects. Out of numerous applications received from across India, only 25 candidates will be selected, announced on August 1st, following a competitive screening process. The final date for application submission is July 15, 2025.
As India emerges as a hub for global clinical trials, training initiatives like this are indispensable for maintaining international standards. This workshop not only contributes to the professional growth of individual researchers but also strengthens the nation's infrastructure for evidence-based medical advancement.
The organizers stated that this initiative would serve as a model for regional and national capacity-building programmes, promoting ethical vigilance and operational excellence in clinical trials.
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