ISPE announced today that it has brought together a substantial line-up of global regulatory officials and pharmaceutical industry leaders to be plenary speakers at the FDA/ISPE co-sponsored “Redefining the ‘C’ in ‘CGMP’” Conference in Baltimore, June 4-5, 2012. These top regulatory and industry professionals will speak on the key CGMP issues affecting the pharmaceutical industry today.

“This first annual collaborative FDA-ISPE event is on-track to become a landmark conference with unprecedented opportunities for regulators and industry professionals to engage in dialog, solve problems and learn from one another,” said ISPE’s president and CEO Nancy Berg. “It’s not often that a single conference is able to present this many relevant, high-level speakers. The caliber of these speakers illustrates ISPE’s and FDA’s shared commitment to addressing quality and manufacturing challenges to ensure the safety and availability of the world’s drug supply.”

Attendees will receive a rare opportunity to hear directly from the policy makers and influencers affecting business and manufacturing in the 21st century. The plenary sessions will consist of premier presentations focused on global quality, worldwide compliance and the future vision of the pharmaceutical industry.

Plenary speakers at this conference include:

• Janet Woodcock, director, Center for Drug Evaluation and Research (CDER), FDA, USA
• Andy Skibo, executive vice president, operations, MedImmune, USA
• Deborah Autor, deputy commissioner for global regulatory operations and policy, FDA
• Ilisa Bernstein, acting director, Office of Compliance, CDER, FDA
• Mary Oates, vice president of global quality operations, Pfizer, USA
• Gerald Heddell, director of inspection, enforcement and standards, MHRA

More information on the Redefining the “C” in “CGMP” Conference, including complete speaker bios, education details and registration information is available at www.ISPE.org/2012CGMPCompliance.