Plenary Sessions Day 1

Monday, 4 June 2012

9.00 – 9.45 
Plenary 1
Vision for Quality in the 21st Century
Janet Woodcock, Director CDER, FDA, USA

Janet Woodcock is the director of the Center for Drug Evaluation and Research (CDER) at the FDA. She introduced the concept of risk management in 2000 as a new approach to drug safety. Since 2002, she has led the “Pharmaceutical Quality for the 21st Century Initiative,” the FDA’s highly successful effort to modernize drug manufacturing and its regulation. In 2004, she introduced FDA’s “Critical Path” Initiative, which is designed to move medical discoveries from the laboratory to consumers more efficiently. Most recently, Dr. Woodcock launched the “Safety First” and “Safe Use” initiatives designed to improve drug safety management within and outside FDA, respectively.

Dr. Woodcock previously served as FDA’s deputy commissioner and chief medical officer. Prior to joining CDER she oversaw approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis.

9.45 – 10.30 
Plenary 2
Lean Manufacturing Without Compromising Quality
Andy Skibo, Executive Vice President, Operations, MedImmune, USA

Andrew D. Skibo is executive vice president of operations at MedImmune, and leads various projects, works with external partners and continues to strengthen the Operations Management Team. In 2007, he joined MedImmune as senior vice president, engineering, and was responsible for overseeing large-scale capital projects at all of MedImmune’s facilities, including several sites in the US, the Netherlands and the UK. Previously, Andrew held the position of vice president, corporate engineering and capital projects at Amgen, Inc. Beforehand, he served in engineering management positions focused on pharmaceuticals and bioscience at Skanska, Inc; Foster Wheeler Corp.; Life Sciences International, Inc.; A.D. Skibo & Associates, Inc.; and Genentech, Inc. He holds a master of science degree in chemical engineering, and a bachelor of science degree in organic chemistry, both from Massachusetts Institute of Technology.

13.15 – 14.00 
Plenary 3
Global Quality
Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy, FDA

Deborah M. Autor is the FDA’s Deputy Commissioner for Global Regulatory Operations and Policy. Ms. Autor’s Directorate, one of four created in July 2011, includes the Office of Regulatory Affairs (ORA) and the Office of International Programs (OIP). Recently, she was awarded the 2011 Meritorious Executive Presidential Rank Award. In addition, she leads the FDA’s strategy for confronting challenges of globalization and import safety. She has co-chaired the group that prepared the FDA’s June 2011 report on Pathway to Global Product Safety and Quality, which describes the paradigm shift that FDA must make in order to face the challenges of globalization today, and in the future. Prior to assuming the role of Deputy Commissioner, she served for five years as Director of the Office of Compliance of FDA’s Center for Drug Evaluation and Research.

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