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Safety in Special Situations: Vaccines, Stem Cells and Beyond
Session Chair(s)
Joy A. Cavagnaro, PhD
President
Access BIO, United States
This symposium will provide insights on the key safety considerations influenced by product specific attributes of vaccines, stem cells and novel combination therapies.
Learning Objective : Discuss protocol design issues including cohort size, timing between cohorts, unique safety parameters, monitoring and independent oversight and long term follow for early and late stage clinical development; Identify challenges based on signal detection methodologies in special situations.
Speaker(s)
Vaccines
Julia Barrett, MD, MPH
Greenleaf Health, Inc., United States
Executive Vice President, Drug and Biological Products
Stem Cells
Curtis L. Scribner, MD, MBA
CLSCRIBS Consulting , United States
Consultant
Clinical and Regulatory Considerations for Cell Therapy Development
G. Alexander Fleming, MD
Kinexum, United States
President and Chief Operating Officer
注册方法
Registration override should work.