In this webinar, the featured speakers will be discussing the impact of the new ICH E14 and S7B revisions and how they impact clinical trials. Dr. Darpo will be discussing the new E14 material and will share the practical implications and use cases. Dr. Kleiman will discuss the S7B changes from the view of a clinician, rather than as a nonclinical safety pharmacologist. They will then share their impressions on the new opportunities that these revisions provide for drug development, as well as some thoughts on the as yet unresolved issues that will only become clarified over the next few years as regulators become more familiar with nonclinical data.
Join this webinar to understand the recent changes to ICH E14 & S7B revisions.
Speakers
Robert Kleiman, MD, Vice President, Cardiology & Chief Medical Officer, Clario
Dr. Robert Kleiman is the Chief Medical Officer at Clario, with board certifications in cardiology and cardiac electrophysiology. He has performed research in both basic cellular electrophysiology as well as clinical electrophysiology. Dr. Kleiman trained at the University of Pennsylvania and practiced clinical cardiology for 12 years before joining Clario in 2003.
In his current role, he currently oversees all of Clario’s cardiology services, supports business development and provides cardiac safety consultative services advising sponsors on optimal cardiac safety strategy for their development program (e.g., clinical protocol development, expert cardiac report development and regulatory support).
Message Presenter
Borje Darpo, MD, PhD, Chief Scientific Officer, Cardiac Safety, Clario
Dr. Borje Darpo is Chief Scientific Officer, Cardiac Safety at Clario, with board certifications in cardiology and internal medicine. He completed his cardiology training at Sahlgrenska University Hospital, Göteborg and was appointed Associate Professor at Karolinska Hospital, Stockholm in 2000. Borje held various positions within CROs and the pharmaceutical industry covering a wide variety of therapeutic areas.
Borje represented the European pharmaceutical industry on the ICH E14 Expert and Implementation Working Group between 2000 and 2008. In collaboration with industry and the FDA, he led the IQ-CSRC study, which validated the concept of applying exposure-response analysis on data from early-stage clinical trials to replace the Thorough QT study. This contributed to the revision of the ICH E14 guideline, which since December 2015 allows this approach to replace the TQT study.
In his current role, he supports business development and provides cardiac safety consultative services advising sponsors on optimal cardiac safety strategy for their development program (e.g., clinical protocol development, expert cardiac report development and regulatory support).
Message PresenterWho Should Attend?
- Medical and scientific affairs
- Project management
- Clinical operations, Clinical development, Clinical research
- Regulatory affairs — cardiac safety
- Research site study coordination
- Clinical monitoring
- Outsourcing
- Medical Monitors
- Clinical Scientists
- Imaging Scientists
- Protocol Managers
- Clinical Data Managers
What You Will Learn
- Understand recent changes to ICH E14 & S7B revisions
- Learn about practical implications of these ICH E14 changes and advantages of new pathways for drug developers
- From a clinical point of view, understand S7B revisions and how it will need to be reviewed with in vitro and in vivo cardiovascular (CV) safety data
Xtalks Partner
Clario
Clario delivers the leading endpoint technology solutions for clinical trials. Through experience gained from over 19,000 clinical trials delivered in support of 870 regulatory approvals, Clario fuses scientific expertise and global scale into the broadest endpoint technology platform to enable pharmaceutical, biotech and medical device partners to transform lives. Through Trial Anywhere™, Clario has mastered the ability to generate rich evidence across all trial models: decentralized, hybrid and site-based clinical trials. With 30 facilities in nine countries across North America, Europe and Asia Pacific, Clario’s global team of science, technology and operational experts has been delivering the richest clinical evidence for nearly 50 years.
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