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Plenary Sessions Day 2

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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, USA

Dr. Ilisa Bernstein is the Acting Director of the Office of Compliance in the Center for Drug Evaluation and Research at the FDA. Previously, she was the Deputy Director of the Office of Compliance. In 2006, she was the Director of Pharmacy Affairs at the FDA, and between 2003 and 2006, she was Senior Advisor for Regulatory Policy. From 1991 to 2002, she was a Senior Science Policy Advisor in the Office of the Commissioner. From 2002 until 2003, she was a Senior Associate Director at Pfizer, where she served as a liaison between Pfizer and the FDA. She provided guidance and advice on emerging policies, regulations, and legislation. Ilisa completed a post-doctoral residency at the National Institutes of Health. Also, she has a Doctor of Pharmacy degree from The University of Michigan College of Pharmacy, and a Juris Doctor degree from The American University Washington College of Law.

Mary Oates Photo

8.45 – 9.30 
Plenary 5
Culture of Quality
Mary Oates, Vice President of Global Quality Operations, Pfizer, USA

Mary Oates is Vice President of Global Quality Operations for Pfizer. In this role, she is responsible for Quality oversight of all products made by and for Pfizer for both clinical and commercial use. She holds an undergraduate degree in biochemistry and a Ph.D. in analytical chemistry. Oates is actively involved in industry initiatives that are aimed at enhancing product quality.

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, UK

Gerald Heddell took up the post as Director of the Inspection and Standards (I&S) Division on 4 January 2005. Gerald is a microbiologist who is a Chartered Biologist and a member of the Institute of Biology and the Royal Society of Chemistry. Since leaving the NHS in 1978, he has worked in a succession of progressively senior roles in manufacturing and quality assurance for The Wellcome Foundation, Glaxo Wellcome and GlaxoSmithKline. Gerald has experience in most aspects of pharmaceutical manufacture and control, with a particular interest in sterile products.

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