Pharmacovigilance & Drug Safety in Clinical Trials

This session focuses on the critical aspects of pharmacovigilance and ensuring drug safety throughout the lifecycle of a clinical trial. Topics include adverse event (AE) and serious adverse event (SAE) reporting, signal detection, risk management, and benefit-risk assessment strategies. Subtopics cover global regulatory requirements for safety reporting, including ICH, FDA, and EMA guidelines, as well as post-marketing surveillance practices. Participants will learn how to design safety monitoring plans, implement risk minimization strategies, and use real-time data to prevent potential safety issues. Case studies will demonstrate the management of unexpected adverse events, how timely reporting influences regulatory decisions, and lessons learned from high-profile drug safety incidents. The session will also explore the use of modern digital tools, such as AI and data analytics, to enhance pharmacovigilance processes, detect patterns, and improve predictive safety measures. Additionally, ethical considerations in safety reporting, patient protection, and transparency in communication with stakeholders will be emphasized. By the end of this session, attendees will gain a comprehensive understanding of pharmacovigilance practices, learn to ensure patient safety, and acquire strategies to maintain compliance and high-quality standards in clinical trials.

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