In this free webinar, stay informed about the new draft US Food and Drug Administration (FDA) guidance on the use of data monitoring committees (DMCs) in clinical trials. Attendees will learn about new requirements for committee formation and function and discover best practices for adapting to the new guidance. The featured speakers will discuss the updated guidelines on committee membership, managing conflicts of interest and ensuring confidentiality. Attendees will get insights on how the new guidance affects statistical analysis and data interpretation and get up to speed on the latest reporting requirements for DMCs.
TORONTO, Sept. 25, 2024 /PRNewswire-PRWeb/ -- The new draft US Food and Drug Administration (FDA) guidance on the use of data monitoring committees (DMCs) in clinical trials marks the first update in nearly 20 years. This revision introduces several significant changes to the management and operation of DMCs in clinical trials.
In this webinar, the expert speakers will explore these important updates and their implications for DMCs. Attendees will learn how the potential changes in the guidance will affect the operational aspects of DMCs, including management, statistical analysis and delivery.
This webinar will also provide a comprehensive overview of recent updates and changes in the context of safety data review and management. The discussion will focus on the various committees involved, including those responsible for adaption, safety assessment and a specific mention of non-independent safety committees.
The expert speakers will cover essential topics such as committee membership, conflict of interest (COI) and confidentiality policies. The session will also delve into the standards and protocols for COI, the methodologies used in statistical analysis and the requirements for accurate and timely reporting. Moreover, they will identify the entities responsible for reviewing safety data, ensuring all participants understand their roles and responsibilities in maintaining data integrity and compliance.
Register for this webinar today to stay informed about the new draft FDA guidance on the use of data monitoring committees in clinical trials.
Join experts from ICON, Patricia Braschayko, Senior Manager, Biostatistics; Karen Shaffer, Director, Biometrics (DMC Unit); and Birgit Geiger, Manager, IDEA (DMC Unit), for the live webinar on Tuesday, October 15, 2024, at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Changes to the FDA guidance on Data Monitoring Committees in clinical trials.
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