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Cardiac Safety Considerations in Pediatric Drug Development
Session Chair(s)
Rick Turner
Expert Consultant
DRT Strategies, Inc., United States
There is great interest in reviewing scientific and public health policy issues pertaining to sudden cardiac death (SCD) occurring in apparently healthy individuals in pediatric populations. This session will first provide fundamental information underlying the rationale for developing a sustainable national health care resource in the domain of pediatric SCD prevention. It will also review discussions from the February 2015 Cardiac Safety Research Consortium (CSRC) Think Tank, and describe the resultant initiatives. Finally, it will invite thoughts and suggestions from attendees with regard to additional contributions and refinements to these initiatives.
Learning Objective : Discuss the rationale for developing a sustainable national health care resource in the domain of sudden cardiac death; Describe initiatives brought forth from the February 2015 Cardiac Safety Research Consortium Think Tank.
Speaker(s)
Academic Perspective
Tess Vickers Saarel
Cleveland Clinic, United States
Chair, Pediatric Cardiology
Hospital Perspective
Mitchell I Cohen, DrMed
Phoenix Children's Hospital, United States
Co-Director Heart Center
Industry Perspective
Albert Allen, MD, PhD, MSc
A. J. Allen Pediatric Drug Development Consulting, United States
Consultant
FDA Perspective
Hari Cheryl Sachs, MD
FDA, United States
Lead Medical Officer, Pediatrics Team Leader, DPMH, OND, CDER
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