2nd DIA Cardiac Safety Workshop in Japan
Venue: Hotel Grand Palace
|Event Date/Time: Sep 05, 2011||End Date/Time: Sep 06, 2011|
date submissions of New Drug Application (NDA) in Japan are required to include the E14 cardiac safety data.
The implementation of the ICH-E14 cardiac safety guidance in Japan was somewhat hindered by shortage of domestic clinical facilities, professional services and clinical experience required to support the new requirements. In addition, questions relating to possible ethnic differences and the extrapolation of foreign clinical data, including the E14 mandated Thorough QT (TQT) studies, into Japanese population remain largely unanswered, further impacting the harmonization of the drug development process across the ICH regions. Yet, with the active support of PMDA the Japanese pharmaceutical industry has embraced the new cardiac safety paradigm and this year launched the fi rst formal E14 Thorough QT studies.
The 2nd DIA Cardiac Safety Workshop in Japan will continue to address the key scientific, clinical and regulatory issues of implementation of ICH-E14 in Japan. The meeting will bring together experts from multiple disciplines and is intended to facilitate an open and productive dialogue between regulatory, industry and academic delegates.