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Second ISPE-FDA Event Attracts Top Names, Features Release of Drug Shortage Survey Results


4/17/2013 9:15:48 AM

(TAMPA, FLORIDA, USA, 16 April 2013) – ISPE announced today that it will hold its second annual Redefining the “C” in CGMP conference, 11 – 13 June in Baltimore, Maryland USA. Themed “Ensuring a Reliable Supply of Quality Medicines,” the event will feature strategic education on issues of interest to industry leaders and global regulatory officials focused on quality systems, processes and technology utilization that drive quality enhancements that support a reliable drug supply. “This event is where industry and regulators must come together to share their views on contemporary regulatory issues and solutions,” said ISPE President and CEO Nancy Berg. “The sessions, case studies and workshops will be focused on how great companies are establishing and sustaining a culture of quality through contemporary quality management strategies, new methods and technologies, metrics and more effective approaches to integrating suppliers into quality systems.”

The event will feature top speakers from the pharmaceutical industry and regulatory agencies, including:

• Howard Sklamberg, Director, Office of Compliance, US FDA

• Andy Skibo, Regional Vice President, Biologics-Supply, MedImmune/AstraZeneca

• Gerald Heddell, Director of Inspection, Enforcement and Standards, MHRA, UK

• John Pinion, Senior Vice President, Quality/Compliance, Genentech, Inc.

• Zena Kaufman, Senior Vice President, Global Quality, Hospira

• Cindy Salamon, Vice President, Global Quality Services, Bristol-Myers Squibb

• Carol Bye, Vice President, Pharmaceutical Sciences Quality Operations, Pfizer, Inc.

Education content will focus on providing attendees with new insights and executable action plans to help resolve challenges related to quality leadership, quality metrics, CMO quality management, flexible manufacturing and other hot topics related to product quality and patient safety. The event will also feature the first public release of key data resulting from the ISPE Drug Shortage Survey, with an expert industry team providing commentary on the ISPE research, the impact of drug shortages and potential solutions. A Meet the Press session will feature a joint regulatory and industry panel answering questions from recognized pharma media experts on strategies for industry and regulatory collaboration, as well as compliance and product quality issues.

More information on the Redefining the “C” in CGMP Conference, including complete education details and registration information, is available at www.ISPE.org/2013CGMPConference. To view a video about this conference, visit http://youtu.be/xVgCJnfJTCQ.

About ISPE

ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA and offices in Brussels, Belgium, Singapore and Shanghai, China. Visit www.ISPE.org for more information.

For more information contact:

Danielle Hould

ISPE Communications Manager

Tel: +1-813-960-2105, ext. 277

email: dhould@ispe.org

www.ISPE.org



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