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.
ABOUT THE DRUG INFORMATION ASSOCIATION (DIA)
DIA is a neutral, global, professional, member-driven association of nearly 18,000 biotechnology, pharmaceutical, academic, and regulatory professionals. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.
Contact: Joe Krasowski