CSRC Annual Meeting 2023

Update on Regulatory Status of Hypertension, Biomarkers and Arrhythmia Monitoring in Clinical Trials. Join us at FDA White Oak Campus to examine proarrhythmia, hypertension and biomarkers.

In Session 1, leading industry professionals will speak on panels discussing:

• Regulations for ECG/QT
• The double-negative conundrum
• Alternative methods for assay sensitivity assessment in routine Phase 1 QT Studies
• Covid-19 and prolonged QT

In Session 2, the following topics will be discussed:

• Small increases in blood pressure and CV risk
• Intermittent versus chronic use of hypertension drugs

In Session 3, the meeting faculty will dive into:

• Biomarkers

In Session 4, the panelists will discuss hot topics in the field such as:

• Biologics/cardiomyopathy and vaccine development
• MACE
• Gene therapies
• Wearables

We will be joined by professionals from FDA Regulatory, Cardiac Safety Consultants, Ltd., Eli Lilly, Richmond Pharmacology, University of Connecticut, Stanford University, University of Pennsylvania, Cleveland Clinic, Clario, Mass General, DSI, Penn Medicine, and UCSF.

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Our CEO Jorg Taubel will be presenting on the topic of alternative methods for assay sensitivity assessment in routine Phase 1 QT Studies, as well as taking part in a panel about Proarrhythmia.