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ISPE

Quality Insider

ISPE, ILF Engage with U.S. and Asian Regulators

Two meetings focused on top industry concerns for pharmaceutical professionals and groups

Published: Monday, May 21, 2012 - 12:01

(ISPE: Tampa, FL) – The International Society for Pharmaceutical Engineering (ISPE) continued its mission to provide a neutral ground for pharmaceutical industry professionals and regulators to discuss industry issues at ISPE affiliate meetings in Japan and China last month. The events brought together officials from the Food and Drug Administration (FDA), the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S), the Pharmaceuticals and Medical Devices Agency (PMDA), the Medicines and Healthcare Regulatory Agency (MHRA), China’s State Food and Drug Administration (SFDA), and other agencies to discuss top industry concerns for pharmaceutical professionals and groups, such as the International Leadership Forum (ILF).

“As the independent pharmaceutical manufacturing association, ISPE is dedicated to strengthening the industry through meetings like the ones just concluded in Japan and China,” says ISPE’s president and CEO Nancy Berg. “These meetings were enormously successful in providing a forum for regulators and industry from two of the top pharmaceutical world markets to engage in face-to-face dialogue around real-world problems and solutions.”

Key topics of the Japan affiliate meeting, held April 12–13, 2012, included international harmonization and the effects of globalization, particularly in regard to counterfeiting and drug shortages. The China meeting, held April 16–17, 2012, focused on the introduction and implementation of China’s new good manufacturing practices (GMP) guidelines and featured open and frank panel discussions with SFDA.

These meetings also marked the first Asia-Pacific meetings of the ILF, a global advisory group of pharmaceutical manufacturing, development, engineering, and quality executives working through ISPE and dedicated to providing leadership and direction on critical technical issues facing the industry. The ILF discussed its global positioning strategy (GPS) document with regulators and industry leaders at both meetings.

“The joint meetings, which included participation by industry leaders and Chinese and Japanese health authority representatives, were collaborative and productive,” says Lou Schmukler, ILF advisor and president of Global Manufacturing and Supply for Bristol-Myers Squibb. “The GPS was well-received, and valuable input was shared. We see the GPS being an important initiative in supporting industry progress in this region.”

The ILF’s GPS document is available for review and comment at the ILF website. The ILF’s next meeting will be held during the joint FDA/ISPE “Redefining the ‘C’ in CGMP” conference in Baltimore, Maryland, which is scheduled for June 3, 2012.

For more information on upcoming ISPE meetings and conferences, visit www.ISPE.org/Events.

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ISPE

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.