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International All-star Speaker Line-up at Annual ISPE Event

(TAMPA, FLORIDA, USA, 01 OCTOBER 2008) – ISPE, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, announced today its full line-up of regulatory speakers presenting at the 2008 ISPE Annual Meeting being held 26-29 October in Boca Raton, Florida, USA.

“We couldn’t be more excited about the significant contributions we are getting this year from experts representing the world’s regulatory agencies,” said Doug Ellsworth, ISPE’s International Regulatory Affairs Advisor. ”This will truly be an opportunity for pharmaceutical professionals to learn first-hand about emerging global industry trends and practices.”

In addition to the wide variety of presenters from top pharmaceutical companies such as Abbott, AstraZeneca, Bristol-Myers Squibb, Johnson & Johnson, Schering Plough, Vetter, and Wyeth, attendees will have the opportunity to interact with representatives of international regulatory agencies during the following discussions:

• Janet Woodcock, Director of the Center for Drug Evaluation and Research at the US FDA will be delivering a keynote address. 
• Product Quality Lifecycle Implementation (PQLI) and a practical approach to global implementation of ICH documents. Regulators confirmed for this session:, Yukio Hiyama (NIHS), Frank Holcombe (US FDA), Jacques Morenas (AFSSA PS, France), Moheb Nasr (US FDA), Jean-Louis Robert (EMEA), and Joe Famulare (US FDA). 
• Risk-MaPP and use of risk-based techniques to manage cross contamination. Regulators confirmed for this session: Tor Graberg (PIC/S). 
• Financial, legal, technical, and regulatory issues facing biosimilars. Regulator confirmed for this session: Dr. Anthony Ridgway (Health Canada). 
• Quality Laboratory Facilities Baseline® Guide: A Roadmap to a Compliant, Cost-effective Lab. Regulator confirmed for this session: Fred Fricke (US FDA). 
• Competing in the Global Marketplace. Regulator confirmed for this session: Ali Afnan (US FDA). 
• Hot Topics in Process Validation. Regulator confirmed for this session: Rick Friedman (US FDA).

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 25,000 pharmaceutical science and manufacturing professionals in 90 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 and industry leaders. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; and its Asia Pacific office in Singapore. Visit www.ISPE.org for additional Society news and information. For information about ISPE Annual Meeting, please visit www.ISPE.org/annualmeeting.