TOKYO – September 15, 2015 –– ERT, a leading global provider of high-quality patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions today announced it will conduct a complimentary webinar for pharmaceutical researchers throughout Japan. The webinar, “Future of Cardiac Safety in Clinical Development” will be presented at 11:00 am Japan Standard Time on September 24, 2015. Webinar registration can be found here.
The one hour webinar is presented by Dr. Yuji Kumagai, Professor of Clinical Research Center, School of Medicine, Kitasato University, and Director of Clinical Trial Center at Kitasato University Hospital. He will expand the basic understanding of cardiac safety, delving in to new concepts and various factors affecting designs of clinical trials. Practical applications and the limitations of several approaches to cardiac safety clinical trials, including a recent U.S. FDA study on ethnicity considerations in TQT study design will also be explored.
“There may be some confusion about the future of cardiac safety in drug development,” said Dr. Kumagai. “While the pharmaceutical industry’s approach to implementing Thorough QT (TQT) studies on ICH was successful in decreasing the risk of torsades de pointes (TdP) and fatal arrhythmias, the introduction of a new concept in early phase PK/PD analysis as an alternative has changed the debate.”
“ERT is committed to ensuring the pharmaceutical industry has access to current information on measuring the cardiac safety of new drugs during development,” said Amy Furlong, Executive Vice President, Cardiac Safety and eClinical Insights Solutions. “During this webinar, we hope to engage the audience in an interactive discussion about recent trends and the implications of alternative methods in ensuring patient safety.”
ERT (http://www.ert.japan.com) is a leading provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services and clinical consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle. ERT delivers the most widely deployed solutions in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, electronic Clinical Outcome Assessments (eCOA) – which includes patient-, clinician-, observer- and performance-reported outcomes – and cloud-based analytics and performance metrics. By efficiently integrating these solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes and delivers safety and efficacy data critical to the approval, labeling and reimbursement of pharmaceutical products. ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Switzerland, Japan and Germany. Join ERT on Facebook, LinkedIn, Twitter, and YouTube.
About Dr. Yuji Kumagai
Dr. Yuji Kumagai is a clinical pharmacologist. He graduated from Medical College of Oita, Oita, Japan. He received post-graduate training on clinical pharmacology, especially in cardiac drugs, at the Medical College of Oita, Oita, Japan. After conducting several important works in the field of clinical pharmacology and chronobiology, he moved to Kitasato University where he has concentrated on clinical trials. Dr. Kumagai is now a professor of Clinical Research Center, School of Medicine, Kitasato University, and also the Director of Clinical Trial Center at Kitasato University Hospital. Besides managing all of the clinical trials in the hospital, he personally conducts many clinical trials including PK, PK/PD, first in human, microdose and Thorough QT studies. He is an ex-board member of the Japanese Society of Clinical Pharmacology and Therapeutics, a council member of the Japanese Pharmacological Society and a board certified supervisor of clinical pharmacologists.