Advanced Clinical Trials and Clinical Research

Global Regulatory Landscape

Navigating the global regulatory landscape is essential for multi-country clinical trials. This session provides an in-depth overview of international regulations governing drug development and clinical research, including FDA, EMA, PMDA, MHRA, and ICMR guidelines. Attendees will learn how to harmonize protocols, manage submissions through portals like CTIS and ClinicalTrials.gov, and address differences in ethics committee processes. Topics also include data privacy regulations (GDPR, HIPAA), regional GCP expectations, and timelines for trial approvals. The session will explore strategies for managing regulatory inspections, handling noncompliance, and preparing documentation to meet local and international requirements. Real-world examples of successful global trial execution will be shared. Whether planning regional expansion or navigating post-Brexit and post-pandemic regulatory shifts, this session offers critical guidance for ensuring regulatory alignment and study continuity worldwide.