Check this out! The “Who’s Who” of ICH will be presenting their expectations for implementing the Q8 and Q9 Quality Guidances in the USA, EU and Japan on 6-7 December at the Omni Shoreham Hotel in Washington, D.C. USA. Learn first-hand what these important developments mean for you and your organization. Hear directly from the designers of the ICH Q8 and Q9 Pharmaceutical Development and Quality Risk Management Guidances, as well as recognized experts from regulatory authorities and industry in the USA, EU, and Japan as they examine the challenges and benefits associated with implementing Q8 and Q9. Find out what they really mean and what they could not agree on… What the remaining significant challenges for implementation are and how these challenges will be dealt with in the future… What is in the future at ICH?…Are we really harmonized? Members of the ICH Expert Working Groups will also provide firsthand insight on what is and is not in the Guidances, the rationale, and what it means for you and your organization. If you are an executive, manager, engineer or scientist working in quality assurance, quality control, manufacturing, regulatory affairs, drug development, compliance, validation or R&D, you cannot afford to miss this event! Check out the program or register at www.ISPE-PDA.org/Q8Q9. This program will only be presented on 6-7 December in Washington and 12-13 February in Brussels. Don’t miss out!

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Regulators and industry leaders lead the charge for change in the industry during the ISPE 2006 Annual Meeting held 5-8 November in Orlando, Florida, USA. Almost 2,000 pharmaceutical manufacturing professionals attended the Annual Meeting for ISPE, a global association of more than 23,000 pharmaceutical manufacturing professionals.

More than 31 educational sessions focused on ASTM, Quality by Design, RFID trends, biotechnology, drug shortages, and risk management, and represented more than 250 speakers over the successful five-day event. Moheb Nasr, Director, ONDQA, CDER, of the US Food and Drug Administration, presented the keynote address and gave the FDA’s perspective on the need for strategic innovation in the industry, while Nat Ricciardi, President of Pfizer Global Manufacturing, offered his insights and made clear the necessity for innovation in this changing industry.

“This year, as we enter ‘A New World of Innovation,’ we look ahead to the next 25 years, to a future of new ideas and new ways of working,” said Jane R. Brown, ISPE Chairman of the Board, during her keynote speech. “There will be challenges in the development of these new medicines, but many of the hurdles we now face will no longer exist because of the collaborations we are forming today between industry, regulatory agencies, and academia.”

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ISPE’s President and CEO Bob Best presented the annual membership awards on 8 November at the Society’s Annual Meeting. And the winners are:

Drum roll please…

Alain Cruset received the Richard B. Purdy Distinguished Achievement Award. This award honors an ISPE Member who has made significant, long-term contributions to the Society. Named after one of the Society’s founders and most accomplished Presidents, recipients are considered to be members of ISPE’s “Hall of Fame.” Cruset has contributed to almost every aspect of the Society in the past two decades, and even in retirement continues to work for ISPE. He was the Chairman of two European Congresses; has chaired the International Development Task Team; and is helping to launch the new Manufacturing Management COP. He is a former member of the International Board of Directors, a founder, past president, current member of the French Affiliate Board, and a visionary for the Society.    

Sion Wyn was awarded the Professional Achievement Award, which honors an ISPE Member who has made a significant contribution not only to ISPE, but to the pharmaceutical manufacturing industry. This award has only been presented six times to date. Wyn has worked behind the scenes for the past 15 years to produce ISPE technical documents, which have made the industry far more efficient. Since the 1990s, he has worked on every GAMP® update, all Baseline Guides, many Good Practice Guides, and several white papers submitted to regulatory authorities. 
 

Dave DiProspero was awarded the Max Seales Yonker Member of the Year, which honors the ISPE Member who has made the most significant contribution to the Society during the past year. It is named in honor of a dynamic lady who contributed to the Society in many different ways and served as a source of inspiration during her battle with cancer. DiProspero has been heavily involved in all aspects of ISPE’s educational development for several years, most recently as the Chair of the newly formed Training Advisory Committee.  This past year he guided the initiative of the Certification Training Task Team to perform a gap analysis of programs available in the ISPE library compared to the competencies required within ISPE’s new Professional Certification.
GlaxoSmithKline was named Company of the Year, recognizing the outstanding support provided by a company as reflected by significant active participation in the Society’s committees, councils, task teams, COPs, programs, and activities. This year’s recipient has been one of the Society’s strongest supporters in 2006 and for many years prior, generously encouraged the participation of many of their employees on ISPE international and affiliate/chapter committees both as Members and Chairs.
 

The ISPE Argentina Affiliate was named Affiliate of the Year, recognizing the outstanding work of one of the 21 International Affiliates, as reflected by membership development and services, management, industry and society support, and innovation.
Since 2004, the Argentina Affiliate has recruited 239 members. In April the Affiliate was launched with more than 200 industry professionals in attendance. They have created a Web site, become active in ISPE international events and committees, engaged with universities, and started Student Chapter initiatives. 
 

Joydeep Ganguly and Gerritt Vogel received The Roger F. Sherwood Article of the Year Award for their article, “PAT and Scalable Automation for Bioprocess Control and Monitoring: A Case Study,” published in the January/February issue of Pharmaceutical Engineering. This award recognizes the contribution of authors to Pharmaceutical Engineering. Magazine and articles are evaluated by a panel of global volunteer reviewers using criteria including the importance, timeliness, value of the subject matter and the quality of the presentation to honor excellence in contributions to the magazine.
 

San Francisco Bay Area was awarded the Chapter of the Year Award, for the third consecutive year, in recognition of its outstanding work and pursuit of excellence by one of the 16 North American Chapters in the areas of membership development and services, management, industry and society support, and innovation. San Francisco retained 95 percent of its members this past year. They are a strong supporter of students and the formation of Student Chapters, including offering internships and active mentoring.  Their community and humanitarian services cannot be matched. They have judged math and technology projects for primary and secondary schools, sponsored a biotech contest at a high school, and developed a program to encourage elementary school students to consider engineering as a career.
 

Pilot Journal Task Team was awarded the Committee of the Year Award for its work on ISPE’s second publication, the Society’s new peer-reviewed Journal of Pharmaceutical Innovation.  The journal’s editor, Associate Professor from Duquesne University, Dr. Jim Drennen, accepted this award.
 

Campbell University Chapter was awarded the Student Chapter of the Year, and was recognized as an enthusiastic Student Chapter that strives for excellence in membership growth, management, society support, activities, and public relations. This dynamic group of 54 future industry leaders offered a variety of events throughout their busy school year, ranging from meetings with industry speakers, to career fairs, to special science events at a local high school.
The Student Poster Competition Awards were presented to undergraduate Dawn Eriksen of the University of Massachusetts, and in the graduate division, to Carlo Benedetti, of Universite de Sherbrooke. This annual international competition is made up of finalists from local Chapter or Affiliate poster competitions held earlier in the year. The visual display of their research or program highlights will be judged for overall appearance, content and presentation skills. Six years ago the North American Affiliate Council launched a Student Poster Competition which has continued to grow since then. Preliminaries are held in the Chapter areas and finalists have been invited to compete here this week.
Congratulations to all for making ISPE even stronger! 

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Nat Ricciardi, President of Pfizer Global Manufacturing, offered some words of wisdom in his keynote speech at the ISPE Annual Meeting, to the crowd of 1,500 pharmaceutical manufacturing professionals. 

“The next five years does not approximate the change in the past 30 years,” said Ricciardi. “Those of you who long for the good old days, forget it.”  You will need to find solutions that will “motivate you to be creative and innovative.”
 

Ricciardi told attendees to look at the forces that are playing on the industry today, which are causing significant pressure on cost. We cannot ignore what’s happening in the global economy.

 “We need to change our mindset from self reliance to creating strategic partnerships.”