On 26 May of 2011, Biomedical Systems, a global provider of centralized diagnostic services for clinical trials, held an interactive educational seminar in Tokyo, Japan titled “Practical Implications of the ICH E14 and the Future.” The workshop focused on the essential elements needed to conduct a robust Thorough QT (TQT) study. While the E14 guidance has been existence since 2006, it was only recently that Japanese regulators had officially signed off on the document and that it was adopted by Japanese pharmaceutical companies as a guidance to follow.
Joining Dr. Tim Callahan, Biomedical Systems’ Chief Scientific Officer, on the panel were Maki Ito, MD, PhD, Head, Medical Affairs Office, Shionogi & Co., Ltd., Japan; Professor Yuji Kumagai, MD, PhD, Director, Clinical Trial Center, Kitasato University East Hospital; and Professor Atsushi Sugiyama, MD, PhD, Professor of Pharmacology School of Medicine, Toho University, Japan. The workshop drew an overflow crowd of more than 100 people from more than 40 pharmaceutical, biopharmaceutical, clinical pharmacology units and contract research organizations. Translators were used for the Japanese and English presentations.
“Biomedical Systems has a long history of supporting the educational needs of the pharmaceutical and device industries with workshops on current topics in drug development,” said Kevin J. Klingler, President of Biomedical Systems’ Pharmaceutical Services division. “We have been privileged to have some of the world’s leading researchers join panels on our Cardiac Safety, Pulmonary Function, Imaging, Neurophysiology and Digital Pathology workshops and webinars where we have educated thousands in the industry.”
About Biomedical Systems
Biomedical Systems is a global provider of centralized diagnostic services for the pharmaceutical and medical device industries. With offices in North America, Europe and Asia, Biomedical Systems has worked on over 8,000 studies involving 14,000 investigative sites in 95 countries around the world for Phase I - IV clinical trials. Biomedical Systems centralized services include the acquisition, analysis and management of data for Cardiac, Pulmonary Function, Imaging, Neurophysiology and Digital Pathology modalities used to determine safety and efficacy for drugs and devices in clinical trials.
For more information, please contact Craig Pennington, Director of Marketing at 1-800-877-6334 or via email, cpennington@biomedsys.com. Additional information can be found on the Biomedical Systems’ website at www.biomedsys.com.
