ISPE offers a fresh approach to its world-class Professional Development sessions in 2007 with Professional Development seminars that match up new pharmaceutical manufacturing trends with the latest ISPE technical documents.

At ISPE’s Tampa Conference, 12-15 February 2007 at the Hyatt Regency Tampa Bay in Tampa, Florida, USA, attendees can gain a greater understanding of specific practical applications as a result of this strategic match up. Attendees will have the ability to select half-day sessions, moving from one to another to maximize their investment of time and funds during the conference.

Seminars at the Tampa event will highlight Aseptic Processing, the new ISPE Packaging, Labeling and Warehousing Operations (PACLAW 2007) Guide, Oral Solid Dosages, Sterile Manufacturing Facilities, and much more. Eight of these sessions will provide direct information related to new ISPE technical documents which will be released in 2007. These documents are reviewed by the US Food and Drug Administration and are best practices for the pharmaceutical manufacturing industry.

These include:

• ISPE Good Practice Guide for Commissioning and Qualification of Pharmaceutical Water Systems, which will be released February 2007;

• ISPE Packaging, Labeling and Warehousing Operations (PACLAW) Baseline® Guide;

• Bulk Guide Revision;

• ISPE Sterile Manufacturing Facilities Baseline Guide;

• GAMP® Electronic Data Archiving;

• GAMP® Good Practice Guide;

• Oral Solid Dosage Baseline Guide; and

• Good Engineering Practice Good Practice Guide

For more information about the educational sessions, visit www.ispe.org/tampaconference

In addition to educational sessions, workshops will be held about the new Certified Pharmaceutical Industry ProfessionalTM (CPIPTM) – a new International Credential for Pharmaceutical Industry Professionals. The one hour free workshops feature a CPIP introduction, the latest on eligibility criteria, the application process, and an examination overview. For more information, visit http://www.ispe-pcc.org/

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ISPE will join the American Association of Pharmaceutical Scientists (AAPS), a partnership of two leading organizations serving the pharmaceutical industry, to present two Life Sciences Job Fairs at the upcoming INTERPHEX events in Puerto Rico and New York, in collaboration with Reed Life Sciences.

A Life Sciences Student Job Fair will be held 1-2 February 2007 at the Puerto Rico Convention Center in San Juan, in conjunction with INTERPHEX Puerto Rico. The Fair will serve the needs of senior- and graduate-level university students interested in scientific and technical positions within Puerto Rico’s robust life sciences industry. In addition, a Life Sciences Job Fair for all levels of industry professionals will be held at INTERPHEX in New York on 24-26 April 2007 at the Jacob K. Javits Convention Center.

The 2007 INTERPHEX event will feature more than 950 exhibitors, an expanded conference program, and a high-profile roster of keynote speakers. “These job fairs have created a unique opportunity for three organizations to work together to enhance career opportunities for both life sciences students and professionals,” said Bob Best, President/CEO of ISPE, a global Society of pharmaceutical manufacturing professionals representing more than 23,000 Members.

Both ISPE and AAPS are dedicated to enhancing the careers of pharmaceutical manufacturing industry professionals and shaping initiatives to help educate the pharmaceutical professionals of the future. The INTERPHEX events, well-established as the leading trade shows for pharmaceutical and biotechnology development and manufacturing, provide highly appropriate venues to ensure the success of both Fairs.

“The AAPS-ISPE/INTERPHEX career partnership provides an industry-wide service that will have a meaningful and lasting impact on the life sciences community,” said John Lisack, Jr., CAE Executive Director of AAPS, a professional, scientific society of more than 13,000 Members employed in academia, industry, government, and other research institutes worldwide. The Job Fairs offer comprehensive hiring solutions for life sciences companies interested in tapping into a talented pool of engineering and scientific professionals, from entry level students to seasoned industry veterans.

Participating companies will have the ability to solicit resumes, screen candidates, and conduct on-site interviews for a variety of positions including those in the areas of research and development, manufacturing engineering, operations/maintenance, architecture/engineering/construction, and packaging. Attendees of the Job Fair will find it an extremely efficient means of conducting job searches. In addition, attendees can visit www.lifesciencesjobfair.org throughout the year, which will provide ongoing career support. Both job seekers and companies who would like more information should visit www.lifesciencesjobfair.org.

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2007 Student Leadership Forums will be held:

East Coast in Raleigh, NC, Saturday, 27 January 2007

West Coast in Walnut Creek, CA, Saturday, 3 February 2007

Who Should Attend: Students interested in the pharmaceutical industry as a career choice

University students are invited to these two free leadership forums to exchange information, ideas, and lessons learned among students, professionals and faculty.

COMPLIMENTARY to Students, Faculty Advisors and those participating in Student Leadership Forum, (includes lunch)

Dress code is business casual for professionals. Students should dress in their interview attire.

Please RSVP to Lynne Richards at lrichards@ispe.org.

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ISPE has announced it will collaborate with the US Food and Drug Administration (FDA) to facilitate the implementation of the new quality guidelines (Q8 and Q9) developed by the International Conference on Harmonization (ICH).

Moheb Nasr, PhD, of FDA’s Center for Drug Evaluation and Research (CDER), announced the Agency’s interest and willingness to work with ISPE to facilitate the implementation of the ICH Q8 and Q9 Guidelines during the keynote session at ISPE’s recent Annual Meeting.

The following day, Dr. Nasr, Joe Famulare of FDA CDER/Compliance, and representatives from ISPE’s Regulatory Affairs Committee (RAC) met. A vision and roadmap for implementation was discussed and FDA will be willing to provide advice on these plans.

ISPE Workshop The ISPE team has scheduled a workshop in June, which will include FDA participation to discuss the issues and gain industry input on the initiative. The session will be held the 6-7 June 2007 at the Crystal Gateway Marriott in Alexandria, Virginia, in conjunction with the ISPE Washington Conference, which will be held from 4-7 June.

“This initiative will have a significant impact for companies interested in FDA’s offer to provide regulatory flexibility by providing new ways to file drug applications, supplements, and implement modern quality systems,” said Paul D’Eramo, Johnson & Johnson’s Executive Director for Quality and Compliance Worldwide and Chair of ISPE’s Regulatory Affairs Committee. “We strongly encourage all professionals working in these areas to attend the workshop and provide their input.” Related Events Prior to the June workshop, three other events will provide important background for the effort.

These seminars represent ISPE’s efforts to collaborate with other associations, as well as FDA, European, and Japanese regulators to explain the new ICH guidelines and discuss implementation plans with a wider audience.

Other seminars include:

ISPE/PDA Sponsored Conferences 12-13 February 2007 Radisson SAS Royal Hotel, Brussels, Belgium. With a focus on ICH Q8 and Q9, this session will feature presenters from the committees that develop the guidelines in each of the three participating regions, the US, Europe and Japan.

Then on 28 February - 2 March, FDA/ISPE/AAPS Sponsored Conference will be held at Bethesda North Marriott Hotel Bethesda, Maryland, USA. This workshop is a follow-up to the PQRI/FDA workshop, “Drug Quality Systems For The 21st Century,” held in April 2003. The latest session will present progress on FDA’s pharmaceutical quality initiatives.

For more information, visit www.ispe.org.

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