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
鈥ackground on ICH E14 Regulatory Guidance
鈥ytotoxics vs. noncytotoxics
鈥he classic thorough QTc study in normal healthy volunteers
鈥esign considerations for QTc assessment in subject population
鈥ow phase 1 QTc assessment supports later phase ECG scheduling in oncology
鈥mportance of baseline ECGs.
WEBINAR HIGHLIGHTS
鈥ackground on ICH E14 Regulatory Guidance
鈥ytotoxics vs. noncytotoxics
鈥he classic thorough QTc study in normal healthy volunteers
鈥esign considerations for QTc assessment in subject population
鈥ow phase 1 QTc assessment supports later phase ECG scheduling in oncology
鈥mportance of baseline ECGs.
