ISPE and ILF engage with U.S. and Asian regulators at meetings.
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Press Release Summary:
ISPE continued its mission to provide neutral ground for pharmaceutical industry professionals and regulators to discuss industry issues at ISPE Affiliate meetings in Japan and China. Key topics of Japan Affiliate meeting included international harmonization and effects of globalization, particularly in regards to counterfeiting and drug shortages. China meeting focused on introduction and implementation of China's new GMP guidelines and featured open and frank panel discussions with SFDA.
Original Press Release:
ISPE, ILF Engage with US and Asian Regulators at Meetings in Japan, China
(TAMPA, FLORIDA, USA) - 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 12 - 13 April, included international harmonization and the effects of globalization, particularly in regards to counterfeiting and drug shortages. The China meeting, held 16 - 17 April, 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 website. The ILF's next meeting will be held during the joint FDA/ISPE "Redefining the 'C' in CGMP" conference in Baltimore, Md. USA on 3 June.
For more information on upcoming ISPE meetings and conferences, visit www.ISPE.org/Events.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is a not-for-profit Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.
