Join us for this 90-minute webinar in which industry experts will discuss and describe the current regulatory environment in cardiac safety, specifically in the development of oncology compounds. Recent FDA feedback and subsequent inquiries from sponsors of oncology drugs reflect a more proactive and pointed call for increased vigilance of these compounds. The speakers will also review the application of both ECG and Echocardiography assessment in the context of current regulatory guidance.
WEBINAR HIGHLIGHTS
•Background on ICH E14 Regulatory Guidance
•Cytotoxics vs. noncytotoxics
•The classic thorough QTc study in normal healthy volunteers
•Design considerations for QTc assessment in subject population
•How phase 1 QTc assessment supports later phase ECG scheduling in oncology
•Importance of baseline ECGs.
WEBINAR HIGHLIGHTS
•Background on ICH E14 Regulatory Guidance
•Cytotoxics vs. noncytotoxics
•The classic thorough QTc study in normal healthy volunteers
•Design considerations for QTc assessment in subject population
•How phase 1 QTc assessment supports later phase ECG scheduling in oncology
•Importance of baseline ECGs.
