The National Medicines Regulatory Authority(NMRA) successfully conducted a two-day training program on “Ensuring Regulatory Compliance in Clinical Trials: GCP and Inspections for Regulators”on 9th and 10th September 2025 at SLF. The program was designed to strengthen the capacity of regulators, inspectors, and clinical research professionals in ensuring compliance with international standards for ethical and high-quality clinical trials. Throughout the training, participants gained valuable insights into the latest updates on ICH-GCP E6(R3) guidelines, the conduct of GCP inspections, and both theoretical knowledge and essential soft skills such as communication and critical thinking. Sessions also focused on regulatory expectations, inspection readiness, and practical approaches to enhancing clinical trial oversight. In addition, case studies and interactive discussions with experienced experts provided participants with practical, real-world perspectives.

The training brought together a diverse group of professionals, including Prof. Asita de Silva, Madeline Ducatte (USA), Dr.Chamini Kanatiwela, and ACRP-certified auditors P. Ellawala and S. Ajanthan,fostering collaboration and knowledge sharing to strengthen the conduct of clinical trials in Sri Lanka. Renowned clinical trial experts Prof. Channa Ranasinghe, Dr. Ananda Wijewickrama, Dr. Rajiva de Silva, Dr. Nadeeka Chandrarathne, and Dr. Nuradh Joseph further enriched the sessions by sharing their extensive expertise and practical experience, fostering meaningful discussions and deeper understanding among participants. The program concluded with positive feedback, highlighting NMRA’s strong commitment to ensuring GCP compliance and readiness for future inspections.