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Douglas Ellsworth named ISPE’s Regulatory Affairs Advisor

(TAMPA, FLORIDA, USA, 23 June 2008) – ISPE, a global, not-for-profit Society of 25,000 pharmaceutical science and manufacturing professionals, has named Douglas Ellsworth its International Regulatory Affairs Advisor, effective 15 July. In this role Ellsworth will help expand relationships with regulatory authorities worldwide, keep ISPE Members informed about significant regulatory developments, and recommend new projects.

“We are extremely fortunate to add Doug Ellsworth to our strong regulatory team,” said Bob Best, ISPE President and Chief Executive Officer. “Doug brings 34 years of regulatory experience in some key, wide ranging positions that will enable him to guide us in our role as the ‘integrator’ of industry, regulatory authorities, and academia for the benefit of the pharmaceutical industry and the patients it serves.”

Ellsworth joins ISPE’s two other Regulatory Affairs Advisors, John Berridge and Bob Tribe. Tribe is ISPE’s Regulatory Affairs Advisor for the Asia Pacific, based in Canberra, Australia. He joined ISPE from the Therapeutic Goods Administration (TGA) in Australia, where he served as Chief GMP Auditor for 23 years. During that time, he not only enhanced the TGA’s reputation as a leading GMP regulator internationally but also held leadership positions with the Pharmaceutical Inspection Cooperation Scheme (PIC/S), serving as vice chairman in 1998-1999 and chairman in 2000-2001. John Berridge, PhD, is ISPE’s European Regulatory Affairs Advisor, assisting ISPE in its interactions with European regulatory authorities as well as helping to move forward ISPE’s new Product Quality Lifecycle Implementation (PQLI) initiative. Berridge retired from Pfizer Global Research and Development at Sandwich, England at the end of January 2006 as European Vice President of Pharmaceutical Sciences.

Ellsworth will retire 3 July as the District Director of the US Food and Drug Administration’s (FDA) New Jersey District. He was responsible for their investigational and enforcement activities in New Jersey, as well as outreach activities to promote voluntary compliance and consumer understanding about matters regulated by the agency. During his tenure as District Director, Ellsworth served as Chair of FDA’s Field Drug Committee, which works with other FDA components to establish US pharmaceutical inspection policies and approaches. He also served on the agency’s Council on Pharmaceutical Quality, a guiding body intended to modernize the regulation of pharmaceutical manufacturing and product quality. As part of FDA’s efforts to modernize pharmaceutical regulation, Ellsworth served on numerous cross-cutting FDA workgroups and steering committees to facilitate adoption by FDA and industry of quality by design, risk management, and robust quality system concepts.

Prior to becoming the Director of FDA's New Jersey District, Mr. Ellsworth was Director of the Division of Manufacturing and Product Quality in the Center for Drug Evaluation and Research (CDER). That Division was responsible for establishing US policies concerning current Good Manufacturing Practices for pharmaceuticals. During his term in this position, Ellsworth initiated international collaborations that ultimately resulted in international GMP standards for active pharmaceutical ingredients. He also served as the lead CDER negotiator for the FDA/EU Mutual Recognition Agreement on Pharmaceutical GMP Inspections.

Mr. Ellsworth joined FDA in 1974 and his duties have encompassed a wide range of scientific and managerial positions, including laboratory research, project management in new drug evaluation, administering public advisory committees, managing regulatory affairs activities, directing policy and compliance activities, and negotiating international agreements. Ellsworth earned a Bachelor of Science degree in Microbiology from the University of Maryland, and has earned numerous FDA awards including two Awards of Merit (FDA’s highest honor award); the Secretary’s Award for Distinguished Service (Department of Health and Human Services Award); the CDER Director’s Special Citation for exceptional efforts in improving communication between agency components; and a National Performance Review Award from the Office of the (US) Vice President for successful collaborative activities.

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.