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Development and Implementation of clinical QT studies
This workshop will examine the strategic requirements for the development and implementation of a clinical QT study:
Agenda
- What are the reasons for studying drug-induced QTc changes (links between QTc prolongation and proarrhythmic torsadegenic toxicity)?
- What are the regulatory requirements for QTc investigations (implications of E14 regulatory document and industrial experience with the implementation of the document)?
- What are the optimum electrocardiographic components of a QT/QTc study (ECG collection, measurement, and QT correction for heart rate and QT/RR hysteresis)?
- What are the statistical considerations of QTc investigations (QTc variability and power sample calculations of the QTc studies)?
- What are the strategies for running QTc investigations successfully (linking QTc studies to early drug development program, obtaining QTc data from first in man studies, organisation of thorough QT/QTc studies)?
This workshop will examine requirements for pharmacovigilance inspections, from preparation, during the inspection and how to follow up.
The workshop will begin at 09:00 and end at 17:00. Lunch and refreshments will be provided.
About your workshop leader
 Marek Malik is presently Professor of Cardiac Electrophysiology at the University of London, Head of Non-invasive Electrophysiology Unit at St. George's, and Chairman of St Paul's Cardiac Electrophysiology in London. His research interests include electrocardiography and computerised ECG processing, acquired long QT syndrome and assessment of drug-induced changes in cardiac repolarisation including the drug-induced QTc changes. Among others, he is a Fellow of American College of Cardiology, European Society of Cardiology, and Heart Rhythm Society. In his field, he authored 11 monographs and textbooks, and more than 350 articles in peer-review journals. He also served on a number of academic task forces.
To register for the pre-conference workshop click on the link below:
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Reserve an exhibition stand at the Safety Pharmacology World Europe exhibition - book early to ensure optimum stand placement!
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Reserve a stand
For details contact
James Hopkins
+44 207 608 7038 |
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