SOURCE: Xtalks

Xtalks Webinars

September 27, 2017 07:00 ET

Cardiovascular Safety in Biopharmaceutical Product Development - From QT Prolongation and Beyond

TORONTO, ON--(Marketwired - September 27, 2017) - In an Xtalks webinar scheduled for Monday, October 16, 2017 at 11am EDT (4pm BST/UK), industry experts from Bioclinica Jeff Heilbraun, MS, Vice President of Strategic Development, Cardiovascular Safety Services and Bruce Lloyd, MD, Associate Medical Director and Director of Clinical Cardiology Services will discuss cardiovascular safety in biopharmaceutical development.

The cardiac safety ECG environment continues to mature and expand based on scientific advancements and understanding of pathways and systems associated with generating cardiac risk. The most recent ICH-E14 Q&A, and the ensuing cardiac safety conferences and industry meetings, have highlighted the advancements and direction for evaluating the cardiac safety during the drug development process. In addition to the role of ECG data in cardiac safety assessment, there are also considerations related to the "off-target" blood pressure safety signals, which are a consideration from a safety and regulatory perspective.

The objective and learning goals for the webinar will include:

  • Provide attendees with the background and perspective on the use of QT prolongation as a cardiac safety endpoint within drug development, and take it forward to the more recent discussions beyond the Through QT (TQT)
  • Learning about additional ECG intervals under discussion related to cardiac safety assessment
  • An overview of the discussion around the use of long term ECG capture versus the 10 second ECG signal/waveform in clinical trials
  • Provide a case study approach looking at therapeutic indications/class of compounds that require specific considerations
  • Present background associated with the focus on BP as a cardiovascular safety endpoint in recent years, specific to the off-target blood pressure signal, using a case study review approach for the discussion

To learn more about this complimentary event visit: Cardiovascular Safety in Biopharmaceutical Product Development - From QT Prolongation and Beyond


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