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PPDM Open Forum
QTc Assessment in Drug Development: Challenges and Novel Approaches
Thursday, November 15
1:30 pm – 5:00 pm
This Open Forum will consist of the following presentations:
Overview of Standard (E14) vs. New Practices and the Use of Concentration-QTc Analysis in Regulatory Devices
Yaning Wang, Ph.D.
U.S. Food and Drug Administration
Various Designs of QTc Studies
Speaker to be Announced
Operational Aspects of Conducting QTc Studies
Speaker to be Announced
Conducting QTc Assessment in Oncology Population: Challenges and Considerations
Howard Fingert, Ph.D.
Pfizer, Inc.
Exposure/QT Information for Early Clinical Development Decision Making
Megan Gibbs, Ph.D.
Amgen, Inc.
Exposure/QT Modeling of TQT: Impact on Approval and Labeling
Speaker to be Anounced
An additional fee is required to attend the PPDM Open Forum. To register, select the appropriate registration fee under the Special Events section of the registration form.
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