Clinical Trial Ethics, Regulatory Affairs and Patient Safety
Clinical trial ethics, regulatory compliance, and patient safety are fundamental to conducting responsible, transparent, and scientifically robust clinical research. This session will explore key principles governing ethical trial design, informed consent, participant rights, and research integrity. Participants will gain insights into regulatory requirements, clinical trial governance, and standards for protecting research participants. The session will highlight approaches to risk assessment, safety monitoring, adverse event reporting, and benefit–risk evaluation. Experts will discuss the roles of ethics committees, regulatory authorities, investigators, sponsors, and other research stakeholders. Emerging challenges involving data privacy, vulnerable populations, emerging technologies, and international trials will also be examined. The track will emphasize adherence to Good Clinical Practice (GCP), transparency, accountability, and patient-centered research standards.
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