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Xtalks, Online
2024-10-15
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.
Keywords: Clinical Trials, FDA, Clinical Research, CRO, Clinical Data, Regulatory, Regulatory Affairs, Data Monitoring Committees, Regulatory Compliance, FDA Guidance, DMC, Pharmaceutical Regulation, Biostatistics
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Organized by:
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Xtalks |
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Invited Speakers:
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Patricia Braschayko, Senior Manager, Biostatistics, ICON
Karen Shaffer, Director, Biometrics (DMC Unit), ICON
Birgit Geiger, Manager, IDEA (DMC Unit), ICON
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Deadline for Abstracts:
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2024-10-15
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Registration:
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Free Registration
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E-mail:
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tristan@xtalks.com
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