Richmond Pharmacology will be attending the 5th Annual Cardiovascular Risk Assessment Summit taking place 26th to 27th January 2011 in Alexandria, Virginia.Cardiovascular toxicities and related adverse events continue to be one of the leading reasons why drugs are stopped in development and approved drugs are withdrawn from the market. Regulatory authorities have developed detailed guidelines on the importance of cardiac safety testing in the preclinical as well as in the clinical setting prior to market approval. This increased scrutiny of cardiac safety issues and the effect of regulations on the development process have made cardiac safety a top priority for pharmaceutical companies.2011 Program Highlights:

  • Hear an FDA Address on the analysis and interpretation of increases in blood pressure and heart rate
  • Learn results of the ICH meeting on ICH E14 requirements
  • Understand integrative preclinical and clinical perspectives on assessing adverse CV events
  • Improve precision, accuracy and predictive value of early clinical assessment
  • Discuss principal requirements of separating drug-induced and heart-rate-induced ECG changes
  • Hear an overview of novel electrophysiological biomarkers that can be used to predict proarrhythmic risk
  • Discuss serum and imaging biomarkers and their potential relevance in drug development
  • Assess the preclinical correlation of troponin elevation and myocardial injury

Dr J�rg T�ubel, medical practitioner and CEO of Richmond Pharmacology, will be hosting a speaker session scheduled for Day 2 of the conference at 08h50 on �What is New in the Design and Clinical Best Practice of TQT Studies�:Between 2006 and 2009 the FDA has reviewed 165 TQT studies performed since the adoption of ICH E14 guideline in 2005. In May 2010 they reported that 22 of those studies were rejected as inconclusive. There have been a large number of publications of TQT studies and this offers the opportunity to review the most effective approach to conduct definitive TQT studies.

  • Appraisal of the various studies published discussing which designs and processes yield best results
  • Proposals for high quality ECG acquisition and analysis
  • Proposals for alternative methods to assess assay sensitivity in TQT Studies

View full meeting programme: click here

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