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ISPE, ILF Engage with U.S. and Asian Regulators at Meetings in Japan, China

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 FDA USA, PIC/S, PMDA, MHRA, China’s State Food and Drug Administration (SFDA), and other agencies to discuss top industry concerns with key 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,” said 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 dialog around real-world problems and solutions.”

Key topics of the Japan Affiliate meeting, held April 12–13, included international harmonization and the effects of globalization, particularly in regards to counterfeiting and drug shortages. The China meeting, held April 16–17, focused on the introduction and implementation of China’s new 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,” said Lou Schmukler, ILF advisor and president, 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 Web site. The ILF’s next meeting will be held during the joint FDA/ISPE “Redefining the ‘C’ in CGMP” conference in Baltimore on June 3.

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

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