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Global Regulators and Pharma Execs Speak at FDA-ISPE CGMP Conference

Speakers focus on global quality, worldwide compliance, and the future vision of the pharmaceutical industry

Published: Wednesday, April 18, 2012 - 10:26

(ISPE: Tampa, FL) — The International Society for Pharmaceutical Engineering (ISPE), which provides an educational forum for the pharmaceutical industry, has brought together a substantial lineup of global regulatory officials and pharmaceutical industry leaders to be plenary speakers at the Food and Drug Administration (FDA)/ISPE co-sponsored “Redefining the ‘C’ in ‘CGMP’” conference in Baltimore on June 4–5, 2012. These top regulatory and industry professionals will speak on the key current good manufacturing practice (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 dialogue, solve problems, and learn from one another,” says 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. The plenary sessions will consist of presentations focused on global quality, worldwide compliance, and the future vision of the pharmaceutical industry.

Plenary speakers at this conference include:
Janet Woodcock, M.D., the director of the Center for Drug Evaluation and Research at the FDA
Andy Skibo, the executive vice president of operations at MedImmune, which develops, manufactures, and markets formulations for use in immunization programs
Deborah Autor, the FDA’s deputy commissioner for global regulatory operations and policy
Ilisa Bernstein, the acting director of the FDA’s Office of Compliance
Mary Oates, the vice president of global quality operations at Pfizer, the world’s largest research-based pharmaceutical company
Gerald Heddell, director of inspection, enforcement, and standards at The Medicines and Healthcare products Regulatory Agency (MHRA), the government agency that is responsible for ensuring that medicines and medical devices work and are acceptably safe

More information on the conference, including complete speaker bios, education details, and registration information is available here.


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The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.