Hotel Le Meridien , Nice France
Oct 25 2010 8:00AM - Oct 26 2010 5:00PM
Cardiovascular safety of new drugs has been at the center of public attention and concern for more than a decade. Since the release of the ICH-E14 guidance in May 2005 the industry, regulatory and academic debate evolved from a focus on a single dedicated and thorough QT (TQT) study to the broader aspects of developing robust and continuous non-clinical and clinical models to establish scientific and practical methods for cardiovascular risk assessment. While the TQT study is still the centre-piece of clinical QT assessment, there are several initiatives on-going, which look into the predictive value of alternative approaches, such as combining non-clinical data with intense QT assessment in early clinical studies. In addition, with the benefits of more data and better knowledge, drug-induced effects on other ECG parameters, such as the PR and QRS intervals, and on hemodynamic parameters, such as blood pressure, have gained attention as potential risk markers for adverse cardiovascular effects. These and other topics will be discussed at the forthcoming DIA Cardiovascular Safety meeting, alongside presentations of new technologies, methodologies and novel biomarkers for early detection and risk management of drug related cardiovascular toxicity. Event Code:
10113
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