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Off-target Blood Pressure Changes and Evaluation in Drug Development: Safety, Clinical and Regulatory Considerations
Session Chair(s)
Jeff Heilbraun, MS
Vice President, Medical and Scientific Affairs, Cardiology
Clario, United States
There has been an increased focus on changes in blood pressure (BP) related to cardiac safety from a regulatory perspective. This session will provide insight into the “off-target” BP response of drugs outside of cardiovascular drugs from a development and regulatory perspective.
Learning Objective : Describe the impact blood pressure (BP) has in the cardiac safety endpoint in clinical R&D trial design; Discuss current challenges in monitoring BP through the different indications and in the different trial phases; Recognize the regulatory considerations in trial design.
Speaker(s)
Panelist
Mary Jane Geiger
ICON, United States
Vice President and TA Lead, Drug Development Services
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