Join Bioclinica's Cardiovascular Safety experts this October for a 3-part webinar series as they review recent advancements and direction in the evaluation of cardiac safety and efficacy in drug development. Through use of case studies, presenters will share insights focused on the recent ICH E14 Q&A, application of cardiovascular imaging in drug safety monitoring and electronic clinical event adjudication.
Attend one or more of the webinars in this series for a critical review of recent trends in cardiovascular imaging, perspective on use of QT prolongation as a cardiac safety endpoint, and to better understand efficiencies gained through centralized adjudication of clinical outcomes.
Each webinar is designed to be 1-hour long, educational and interactive.
Upcoming cardiac safety webinar dates and times:
October 16, 2017 - 11:00am (Eastern)
Cardiovascular Safety in Biopharmaceutical Product Development – From QT Prolongation and Beyond
The cardiac safety ECG environment continues to mature and expand based on scientific advancements and understanding of pathways and systems associated with generating cardiac risk. The most recent ICH E14 Q&A, and the ensuing cardiac safety conferences and industry meetings, have highlighted the advancements and direction for evaluating the cardiac safety during the drug development process. In addition to the role of ECG data in cardiac safety assessment, there are also considerations related to the "off-target" blood pressure safety signals, which are a consideration from a safety and regulatory perspective.
October 19, 2017 - 10:00am (Eastern)
Cardiovascular Imaging for Monitoring Safety: Visualizing Outcomes
It is paramount that new medical therapies be shown to be safe for patients. Monitoring safety is accomplished in a variety of ways depending on the therapy and its potential adverse impact. There are many therapies that have been shown to have adverse cardiovascular implications and fortunately, innovative tests and tools are available that are effective in monitoring the safety of new biologics, drugs and devices in development. The goal of this webinar is to discuss the application of cardiovascular imaging when monitoring safety in the development of new medical therapies.
October 26, 2017 - 10:00am (Eastern)
Clinical Event Adjudication: Comprehensive and Efficient Dossier Review Using a Global On-Line Solution
New drugs, biologics and devices in development today can be very effective at treating the targeted disease or condition. However, many may also have a negative impact on cardiovascular outcomes and therefore the review of clinical events need to be considered. This webinar will provide an overview of the centralized review of cardiovascular safety through implementation of a Clinical Events Committee (CEC) and the importance of collecting and adjudicating events and providing unbiased assessments through electronic expert evaluation. This presentation will highlight the role electronic expert evaluation plays in improving the quality of endpoint assessments for cardiovascular outcomes. A detailed discussion on the Clinical Event adjudication process workflow will be shared.
Learn more and register for one or all of these webinars today!