Ms. Meeker-O’Connell joined CDER’s Office of Scientific Investigations in March 2010. Prior to FDA, Ann spent 10 years in clinical compliance roles in industry and academia. Ann is actively involved in initiatives to develop risk-based approaches to clinical trial design, conduct, and oversight.
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.
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.
Ms. Meeker-O’Connell joined CDER’s Office of Scientific Investigations in March 2010. Prior to FDA, Ann spent 10 years in clinical compliance roles in industry and academia. Ann is actively involved in initiatives to develop risk-based approaches to clinical trial design, conduct, and oversight.
Description
Current models for clinical trial oversight have become outmoded in a global, complex environment. This session describes recent efforts to foster new models that employ risk-based approaches and that build quality into clinical trials.
Learning Objectives: Describe risk-based approaches that build quality into clinical trials Discuss how monitoring fits within an overall, risk-based quality framework Describe possible approaches for applying quality-by-design and quality risk management principles to clinical trials.