+25 years experience in Drug Regulatory Affairs and Clinical Science. Member of EFPIA, IFPMA, DIA, EFGCP; Strategic Advisory Committee (SAC) of Empowerment with the WHO; DIA Board Director and chair of the Advisory Committee Europe for the term 2008 / 2009 and 2009 / 2010.
Brian J. Nugent, PhD (SPKNON), Associate Director, Clinical Operations, Gilead Sciences, Inc., United States
Over 16 yrs in the industry spanning both biopharmaceutical and CRO organizations with an emphasis on quality, linical operations, process development and safety. His concentration over the past several yrs has been on the development of QRM systems, having just completed a QbD build at Gilead.
Linda B. Sullivan, MBA (SPKNON), Vice President of Operations, Metrics Champion Consortium, United States
Ms Sullivan is VP Operations at the Metrics Champion Consortium (MCC), a non-profit organization dedicated to the development and support of performance metrics within the bio/pharmaceutical industry. She received a BS from Trinity College and a MBA from Dartmouth where she was named a Tuck Scholar.
Description
A risk-based approach to quality management in clinical trials is the obvious solution. However, many sponsors of clinical trials have attempted it and failed. This session will show the essentials and examples of a successful implementation.