Recent developments in the regulatory approach to drug safety in clinical drug development have triggered significant changes in the requirements for new drug applications and criteria for marketing approval. The new requirements, have now been adopted by the ICH organisation (topic E14) for global implementation and are mainly concerned with repolarisation-based (QT prolongation) Cardiac Risk Assessment (CRA). At the centre of these recent initiatives is the need for a well designed, well executed Through QT (TQT) Study with relevant statistical interpretation to ensure the cardiovascular safety of drugs in development.
In addition, recent concerns involving certain COX-2 specific NSAID have highlighted the need for broader cardiac safety surveillance and Cardiac Risk Management (CRM) programmes, extending well beyond regulatory approval into the marketing stage. These concerns have now triggered further regulatory reviews of the drug development process and are expected to introduce further changes to the drug approval process and the post marketing commitments of drug manufacturers.
This programme will review and address the above cardiac safety topics and will bring industry, academic and regulatory experts and representatives together with the aim of exchange of ideas and sharing information with the audience.