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Johns Hopkins Carey Business School Presents Symposium on Health Care Industry Standards

November 21, 2011
For Immediate Release
Media Contact: Patrick Ercolano
Johns Hopkins Carey Business School
(410) 234-9296

How might scientific advances affect compliance rules for pharmaceutical and medical-device companies? Is it possible, or even desirable, to create global regulatory standards for the quality and inspection of health care products? What is the best method for predicting a product’s performance?

Experts from the medical, legal, regulatory, and academic fields will address these and other questions at a symposium “Issues in Global Health: Advancing Efficiency and Quality through Regulatory Science” on Dec. 2, 2011, at the National Press Club in Washington, D.C. The event, to be held from 7:45 a.m. to 3:00 p.m., is being presented by the Johns Hopkins Carey Business School in partnership with the Food and Drug Law Institute (FDLI). Funding is provided by Johnson & Johnson. Carey professors Toby Gordon and Dipankar Chakravarti are co-conveners of the event.

“The goal of this symposium is to create a forum for open discussion on regulatory quality and inspection issues in the pharmaceutical and medical-device industries,” says Phillip Phan, professor and interim dean of the Carey Business School. “We want to encourage the expression of many viewpoints in the interest of bringing the best ideas to light and identifying common interests for follow-up, not to advocate any particular position.”

Phillip Phan

Phillip Phan

After opening remarks by Phan, Chakravarti, and Lloyd Minor, provost and senior vice president of The Johns Hopkins University, the first of two morning panel discussions will begin. Focusing on how to strengthen compliance and enforcement of standards within a global context, it will be moderated by Robert Wanerman, senior counsel in the health care and life sciences practice at the Washington law firm Epstein Becker and Green. The scheduled panelists are Vicki Seyfert-Margolis, senior adviser for science innovation and policy for the Food and Drug Administration Commissioner’s Office; Hilde Boone, the European Medicines Agency’s liaison to the FDA; and Robert Stewart, the executive vice president for global operations at Watson Pharmaceuticals.

The second morning panel will examine “global supply chain realities.” Led by moderator Susan Winckler, president and chief executive officer of the FDLI, the panelists include Lillian Gill of the Cosmetic Ingredient Review; medical-device expert Ron Ginor, CEO of the consulting firm Becker & Associates; and Tom Colonna, associate director of the Bioscience Regulatory Affairs Program at The Johns Hopkins University.

Audience questions, discussion summaries, and breakout sessions are also on the agenda. A morning coffee break and lunch are planned. The National Press Club is on the 13th floor at 529 14th St. NW in Washington. More information on the event can be found at www.carey.jhu.edu/globalhealth.


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