Barbara has over 30 years experience in the pharmaceutical industry, primarily in clinical drug development. In Roche, she has been responsible for numerous regional and global regulatory submissions. She is currently responsible for quality risk management in safety science/pharmacovigilance
Global Clinical Development is responsible for the delivery of all clinical studies and information in support of Eli Lilly and Company's pipeline molecules. The primary responsibility is to patients and healthcare professionals who depend on our products and services.
Dr. Ball is Director, Division of Scientific Investigations, CDER, FDA. She joined the FDA in 1996. Dr. Ball graduated from Georgetown University School of Medicine, where she completed a residency in Pediatrics. She completed a fellowship in Pediatric Infectious Diseases at Walter Reed.
Ken has 17 yrs experience in the industry, leading international teams in the development of NCEs and commercialization of drugs. He previously worked for 16 years as a pediatrician and pediatric cardiologist , then joined Bayer Healthcare (Levitra clinical lead) and Neurogen before Pfizer in 2009.
Description
By reviewing current regulatory and industry initiatives, this session aims to provide clarity in a changing environment, and provide the impetus and information to support those seeking to apply QbD/QRM to add value in their own environment.
Learning Objectives: Elucidate regulators' expectations in application of QbD/QRM in clinical development Assess the different targets for application of QbD/QRM in clinical development in industry Explain how QbD/QRM adds value as a cross-functional activity throughout the clinical development life cycle.