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.
PhD in pharmacology 1986 Joined EMEA in 1999. Coordination of GCP and Pharmacovigilance inspection. Chairman of the GCP Inspectors Working Group and Ad Hoc Pharmacovigilance Inspectors Working Group. Business analyst for the EudraCT database.
Karena Cooper, FDA, United States
Description
This session will discuss the progress of the FDA and EMA GCP initiative, present areas of current focus, and preview future collaborations on inspections as well as GCP policy and guidance.
Learning Objectives: Discuss how the FDA and EMA collaborate on inspections involving clinical research Identify key differerences and similarities between the FDA and EMA policies and guidance in GCP Outline areas of future collaboration between the FDA and EMA.