Registration will commence at 09:00 for a 09:30 start. The workshop will finish no later than 17:00.
The increased focus on drug induced repolarisation abnormalities and its potential outcomes have triggered recent regulatory programmes, culminating in the current ICH (E14) initiative. At the centre of these regulatory initiatives is the need for a well designed and powered Through QT (TQT) Study. During the early period of compliance, and with the evolving E14 guidance document, the TQT study design and implementation has changed dramatically. The current workshop is intended to provide practical advice based on the individual and collective experience of leading experts in the field of Cardiac Safety and regulatory compliance.
Boaz Mendzelevski, M.D., Director of Cardiology, Covance Cardiac Safety Services, brings expert knowledge in clinical and interventional cardiology and electrophysiology and long experience in the core ECG laboratory concept for clinical trials. Dr. Mendzelevski has been a pioneer in establishing the role of Safety Cardiology in drug development clinical research and a founder of a leading international core ECG lab. He was involved in all stages of drug development clinical trials since 1995, from protocol development, through trial monitoring, data acquisition, statistical analysis, expert reporting and regulatory representation. Dr Mendzelevski's research interests are in predictors of arrhythmias and in particular the QT interval. He has served on several Data Safety Monitoring Boards and advisory committees and has been working closely with pharma sponsors as an expert cardiology consultant. His consultancy work involves issues of regulatory cardiac safety including data analysis and interpretation of cardiac related study outcomes. He authored 200 regulatory expert cardiology reports.
Registration will commence at 09:00 for a 09:30 start. The workshop will finish no later than 17:00.
The workshop will explore the application of novel methodologies in exploratory/early stage research, which exhibits clear differences from other business environments in which these methodologies have been successfully applied and demonstrate the possibilities for substantial process and outcome improvement that can be delivered. As this first stage of clinical research by definition is a foray into the realm of the unknown, even the potentially optimal of the process being initiated can't be accurately foretold and is itself a variable. The first section of the workshop will demonstrate how the desired outcome of project management in exploratory development should be the initiation and harmonisation of a range of tests and processes, while setting clear goals to project teams. Current paradigms suggest the setting out of defined systems and benchmarks by clinical phase against which progress can be measured. The workshop will show how.
The workshop will focus on Critical Chain Management and Lean Six Sigma
With CCM, clinical projects can be completed more quickly and with more reliable scheduling, as uncertainty is managed by padding task durations, starting work as early as possible, multi-tasking, and focusing on meeting commitment dates. The workshop will demonstrate how critical chain management can improve delivery on all targets.
The workshop will also examine the potential for application of Lean Six Sigma in exploratory development (Phase I research). Lean Six Sigma uses data and statistical analyses to measure and improve a company's operational performance by identifying and eliminating defects in processes. Historically, Six Sigma has been mainly used in the manufacturing process but the benefits to research and development (R&D) processes have recently been highlighted, in particular applications in exploratory development.