November 28, 2011

Carey School holds symposium on health care industry standards

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 the symposium Issues in Global Health: Advancing Efficiency and Quality Through Regulatory Science on Friday, Dec. 2, at the National Press Club in Washington, D.C. The event, to be held from 7:45 a.m. to 3 p.m., is being presented by the Johns Hopkins Carey Business School in partnership with the Food and Drug Law Institute. 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,” said 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.”

After opening remarks by Phan, Chakravarti and Lloyd Minor, provost and senior vice president for academic affairs at Johns Hopkins, the first of two morning panel discussions will begin. Its topic is “Strengthening Compliance and Enforcement: The Challenges of Globalization,” and 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, executive vice president for global operations at Watson Pharmaceuticals.

The second morning panel will examine the “global supply chain realities” of regulatory compliance and enforcement. Led by moderator Susan Winckler, president and chief executive officer of the Food and Drug Law Institute, the panelists are to 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 Johns Hopkins.

Audience questions, discussion summaries and breakout sessions are also on the agenda.

More information on the event can be found at