Learning Lab brought to you by Certara: Bespoke Comprehensive Cardiac Safety Support at Certara and Recent Experience with C-QTc modeling in Special Populations
Senior Director Certara Drug Development Solutions
Enjoy complimentary lunch! Due to space constraints, seats will be available on a first-come, first-served basis and may run out before the event starts; therefore, please plan to arrive early.
Certara will provide an overview of available Cardiac Assessment support, highlighting a comprehensive range of expertise from a team of clinical pharmacologists and pharmacometricians along an with experienced toxicologist and a cardiologist. A range of offerings are available ranging from QTc assessment and waiver strategies to modeling offerings that can be customized to development milestones, ranging from concentration (C)-QTc feasibility, exploratory C-QTc analysis to full C-QTc analysis suitable to support Regulatory submissions. In addition, broader support available for Healthy Authority Submissions and Communications, with recent experience with integrated assessment of both nonclinical and clinical cardiac safety data will be shared, as well as recent experience, including C-QTc modeling in special populations.
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This event is sponsored by an ASCPT Partner organization. The content of the session is provided for informational purposes only and does not constitute or imply ASCPT's endorsement, recommendation, or approval of a specific institution, service, employer, or content.