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Plenary Sessions

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FDA has joined with ISPE to deliver an integrated learning conference focused on Industry and Regulatory viewpoints. A powerhouse line up of Global regulators and industry health and trade organization leaders discuss evolving compliance issues, improving good manufacturing practices and how to navigate today's pharmaceutical industry. This is a conference you do not want to miss!

Plenary Sessions: Monday, 4 June 2012

Janet Woodcock Photo 9.00 – 9.45

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

Andy Skibo Photo 9.45 – 10.30

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

Deborah Autor Photo 13.15 – 14.00

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

Plenary Sessions: Tuesday, 5 June 2012

Ilisa Bernstein Photo 8:00 – 8.45

Plenary 4
Future Vision for the Office of Compliance
Ilisa Bernstein, Acting Director, Office of Compliance, CDER, FDA

Mary Oates Photo 8.45 – 9.30

Plenary 5
Culture of Quality
Mary Oates, Vice President of Global Quality Operations, Pfizer, USA

Gerald Heddell Photo 9:30 – 10.15

Plenary 6
International Regulatory Perspective: What's New in Europe?
Gerald Heddell, Director of Inspection, Enforcement and Standards, MHRA

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