2nd Cardiac Safety Conference

Posted:
20
November 2007

2nd Cardiac Safety ConferenceBrief Description: ICH E14 QT Guidance were finalised (step 4) in May 2005. However, implementation of the new guidance (step 5) seems to have taken a different pace in different ICH regions, with US FDA leading the trend and Japan PMDA still developing their own version. The controversy regarding the predictive value of different non-clinical and clinical QT assays (including the TQT study itself) continue to underline the regional regulatory variations. As global experience is building up, Thorough QT (TQT) study designs are improving, sample size dropping and the use of positive control(s) becoming more sophisticated. The potential benefits of capturing and viewing multidimensional aspects of continuous QT and morphology data are gathering momentum with innovative technologies and methodologies coming up. Analysing and reporting QT data is also evolving while various TQT outcome scenarios are emerging. Concentration-effect modelling, promoted by US FDA, is increasingly taking a central role in the analysis and reporting of QT data. At the same time certain therapeutic classes, such as oncology and biological products, are still cast with uncertainty and face inconsistent regulatory requirements in the various regions.At the other end of the drug development spectrum, ongoing issues involving post marketing pharmacovigilance continue to make headlines. Cardiac Adverse Reactions, whether repolarisation-based, thrombosis-related or other are reported increasingly, involving a variety of drug classes. While legal and financial liabilities are still strong driving forces for cardiac safety pharmacovigilance, new public and regulatory initiatives are endorsing more proactive risk management and risk minimisation plans. These topics and others will be interactively discussed during the conference.Date: December 3 - 4, 2007Location: Dorint Praha Don Giovanni Hotel, Prague, Czech RepublicStand Number: 4

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