ISPE Global Regulatory GMP Conference will be unprecedented gathering of leading regulatory bodies and pharmaceutical industry professionals

TAMPA, FL, USA, 8 July 2005 – Expert speakers from leading regulatory agencies and the worldwide pharmaceutical industry have now been confirmed for ISPE’s first Global Regulatory GMP Conference, scheduled for 19-21 September, 2005, in Prague, Czech Republic. With the theme “New Regulatory Initiatives and Achieving International Harmonisation,” the three-day conference is an unprecedented gathering of European, USA, and Japanese regulators and leading global pharmaceutical manufacturers. As such, delegates will have a unique environment in which to discuss their own regulatory concerns with the industry and regulatory experts. The conference is part of a year-round programme of educational events organized by ISPE, a global not-for-profit Society of pharmaceutical manufacturing professionals.

The Global Regulatory GMP Conference is geared towards maximum interaction between regulators and industry professionals, with a mixture of presentations, round table discussions and panel discussions. Day One of the conference will feature a plenary session with speakers from seven leading regulatory bodies: the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), the Japanese Ministry of Health, Labour and Welfare (MHLW), the World Health Organisation (WHO), the Pharmaceutical Inspection Cooperation Scheme (PIC/S), the German Bezirkssregierung and the International Conference on Harmonisation (ICH).

On Day Two, conference delegates will hear presentations from eight eminent pharmaceutical industry speakers on a wide range of topics affecting the current global industry, including interfaces between regulators/industry, global inspections, quality systems, Q7A and international harmonisation, supplying investigational medicinal products, methods for prioritising GMP inspections, ISO standards, and pharmaceutical manufacture in Asia. Day Three will feature a panel discussion followed by round table forums in which delegates will be able to discuss their issues in-depth.

“Unlike other regulatory events that only include presentations from a single country’s agency, this conference reflects the global nature of today’s pharmaceutical industry,” said Paul D’Eramo, Executive Director, Johnson and Johnson, USA and Chair of the ISPE Board of Directors. “Professionals from today’s multinational companies are dealing with regulatory challenges on a global scale, and they need to adopt GMP strategies that are effective across international boundaries. This conference will provide an ideal forum for them to address these issues.”

ISPE Prague Conferences
The Global Regulatory GMP Conference is being held in conjunction with the ISPE Prague Conferences, a five-day event featuring seven other sessions addressing the challenges of global pharmaceutical manufacturing. Registration for the Prague Conferences includes the September 19 plenary session of the Global Regulatory GMP Conference, as well as numerous networking opportunities, a Table Top exhibition, and a special evening social event organised by the ISPE Czech/Slovak Affiliate. Delegates to the Global Regulatory GMP Conference are also eligible to attend the social evening. All conferences will be held at the Prague Marriott Hotel in Prague, Czech Republic.

The complete Prague Conferences schedule is as follows:

19-21 September
* Global Regulatory GMP Conference – New Regulatory Initiatives and Achieving Global Harmonisation

20-21 September
* Barrier Isolation Technology Forum
* Biopharmaceutical Facilities and Case Studies

22 September
* GAMP(r) Good Practice Guide for Laboratory Systems Validation

22-23 September
* Planning Strategies for the Effective Management of Global Investigational Medical Product (IMP) Supplies in the 21st Century
* The Challenges and Opportunities in Future Science-Based API Manufacture

23 September
* GAMP 4 – Maintaining the Validated State of Computer Systems

Registration Information
For more information and to register, contact ISPE Registration Services, Avenue de Tervueren, 300, B-1150 Brussels, Belgium, Tel: + 32-2-743 4422, Fax: + 32-2-743 1584, E-mail: [email protected] or visit

Press passes are available for this event. Please contact Karine Desbant, Marketing Manager at ISPE European Office, at tel: +32-2-743 4413, fax: +32-2-743 1550, or e-mail: [email protected]

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for nearly 23,000 pharmaceutical manufacturing professionals in 80 countries. ISPE aims to be the catalyst for “Engineering Pharmaceutical Innovation” by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida; an Asia Pacific office in Singapore; a European office in Brussels, Belgium; and Chapters and Affiliates in 18 countries around the world. Visit for additional Society news and information.
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