Debra Aub Webster
Cardinal Health Regulatory Sciences, USA
Biography
Debra Aub Webster has over 20 years of experience in pharmaceutical research and the regulatory environment. She has started her regulatory career with the US FDA as Reviewing Toxicologist/Pharmacologist. As a Principal Scientist in Regulatory Affairs and Product Development with Cardinal Health Regulatory Sciences, she leads projects for biologic and regenerative medicine product development programs. In this capacity, she provides guidance on clinical, nonclinical and regulatory aspects of strategic product development, author’s regulatory documents and acts as the Regulatory Representative for sponsors in interactions with the FDA.
Abstract
Abstract : Regulatory considerations for regenerative therapeutics: US perspective