2nd Cardiac Safety Conference

Venue: Dorint Praha Don Giovanni Hotel

Location: Prague, Czech Republic

Event Date/Time: Dec 03, 2007 End Date/Time: Dec 04, 2007
Report as Spam


Recent high profile cardiovascular adverse effects of newly approved drugs triggered public concerns and resulted in increased regulatory focus and new guidance concerning cardiac safety of drugs under development. The new guidance documents, ICH topics S7B (non-clinical) and E14 (clinical), are primarily concerned with investigating the effect of new drugs on cardiac repolarisation and the QT interval. At the centre of these initiatives is the need for a well designed, well executed "thorough QT/QTc study" with relevant statistical power to characterise the pro-arrhythmic risk of drugs in development. However, experience with the new QT assessment study is limited and its impact on the late stage development and regulatory approval process are not yet fully understood.
In addition, recent concerns involving certain COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) have highlighted the need for broader cardiac safety surveillance and cardiac risk management programmes, extending well beyond regulatory approval into the post-marketing period. These concerns have now triggered further regulatory reviews of the drug development process and are expected to introduce additional requirements to the drug approval process and the post-marketing commitments from drug manufacturers.
This programme will review and address the above cardiac safety topics and will bring academic, regulatory and industry experts together to exchange ideas and share information with the audience.


Vinohradska 157a
Czech Republic