11 July 2008

ISPE Engineering Regulatory Compliance Conference a Hit in Washington, D.C.

Co-hosted by the FDA, the ISPE 2008 Washington Conference had a capacity crowd that reached close to 600 attendees. Many new Members and first-time conference attendees enjoyed the New Member/First Timer Orientation Breakfast and seemed pleased to have the opportunity to learn more about ISPE and all it has to offer. Also at this year’s conference, two of the 2008 FOYA Category Winning companies held informative sessions about their award-winning facilities. They took questions from the audience and provided insight into their successful pharmaceutical facility projects.

If you were unable to attend, there is still an opportunity to obtain the knowledge shared at each session. For a short time, those who could not attend the conference may purchase CDs of the audio recordings and the hand-outs at the highly discounted rate offered to attendees: $199 for members and $299 for non-members.

 Purchase the conference recordings from Aven.com

11 July 2008

ISPE’s Journal of Pharmaceutical Innovation Publishes Groundbreaking Scientific Papers

The latest scientific papers outlining the progress made on ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative are being publishedhave been in the June 2008 issue of the Journal of Pharmaceutical Innovation. Written by experts representing the global pharmaceutical manufacturing industry, these papers present practical scientific and technological approaches to implementing ICH documents that address Pharmaceutical Development, Quality Risk Management, and Pharmaceutical Quality Systems. Subsequent issues of the magazine will feature PQLI-related articles.

ISPE is actively soliciting your feedback on each of these articles. Click here [ghall@ispe.org] to respond to the articles once you have had the opportunity to read them. Please feel free to forward the article links to friends and colleagues who you think will be interested in reading and/or commenting on them.

In addition to PQLI Innovations, the June edition features research on acoustic experiments and surface decontamination effectiveness, and a case study that proposes a method for determining the criticality of a process parameter.

 Table of Contents, abstracts
 Full text available to ISPE Members from Springer

11 July 2008

Douglas Ellsworth named ISPE’s Regulatory Affairs Advisor

ISPE has named Douglas Ellsworth its International Regulatory Affairs Advisor, effective 15 July 2008. 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.

11 July 2008

Young Professionals Group Seeks Steering Committee Members

ISPE’s Membership Services Committee has launched a new program for Young Professionals. This group is all about meeting the needs of the young professional navigating their way in the pharmaceutical science and manufacturing industry.

ISPE is currently recruiting people for the Young Professionals Group Steering Committee. Members of this committee will work together to develop activities and programs that address the issues young industry professionals face, as well as assist in planning the future of the group through 2008 and beyond.

If you have any questions, or are interested in participating on the Young Professionals Steering Committee, please contact ISPE Staff Project Manager Linda Brady at tel: +1-813-960-2105 ext. 230 or at lbrady@ispe.org.

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