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Global Regulatory Experts Highlight DIA Conference on Cardiovascular Safety in Drug Development

Horsham, PA, USA — Mar 19, 2010

The Drug Information Association (DIA) will host the Cardiovascular Safety in Drug Development: QT, Arrhythmias, Thrombosis, and Bleeding Conference from April 12-13 in Arlington, VA.

This conference, co-sponsored by the FDA and the Heart Rhythm Society, will bring together FDA, PMDA, industry, academic, and global regulatory speakers to discuss the evolution of drug development, cardiac QT issues, cardiovascular safety, and strategies for analyzing and mitigating potential risks to improve cardiac safety analysis during drug development. Featured topics include:

  • Preclinical Testing and QT/Torsade de Pointes Assessment
  • Thorough QT Study
  • ICH E14 Issues Under Consideration
  • CV Safety Unrelated to QT
  • Debate: Automatic QT Assessment Will Replace Manual and Semi-Automatic QT Techniques for the Thorough QT Study

Regulatory speakers include:

  • Suchitra Balakrishnan, MD, PhD, Medical Officer, Division of Cardiovascular and Renal Products, CDER, FDA
  • Albert Defelice, Supervisory Pharmacologist, CDER, FDA
  • Michael Pacanowski, Clinical Pharmacologist, Office of Clinical Pharmacology, CDER, FDA
  • Kaori Shinagawa, MD, Deputy Review Director, PMDA, Japan
  • Norman Stockbridge, MD, PhD, Director, Office of Drug Evaluation, Office of New Drugs, CDER, FDA
  • Robert J. Temple, MD, Deputy Center Director for Clinical Science, CDER, FDA
  • Joanne Zhang, PhD, MS, Mathematical Statistician, Office of Translational Sciences, CDER, FDA
  • Hao Zhu, PhD, Office of Clinical Pharmacology, CDER, FDA
  • Yoshiaki Uyama, PhD, Review Director, PMDA, Japan

“This premier conference will explore ways to analyze and mitigate potential risks that will improve your safety analysis during drug development,” says Program chairperson Philip T. Sager, MD, FACC, FAHA, Vice President, Clinical Research and Head of CV/Metabolic Clinical Development, Gilead Sciences, Inc.

Register for Cardiovascular Safety in Drug Development.

 

 

 

 

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ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.