Role: Recommend policies and procedures to the International Board of Directors that will improve Affiliate services to Members. Chair*: Roger Dowding, Merck Sharp & Dohme Staff Project Manager: Tarnbir Kaur
Body of Knowledge Committee (BOKC)
Role: To make accessible information that fosters understanding of the sciences and technology inherent in each aspect of the development and manufacturing processes in order to promote product, process and technologic innovation. Chairs*: Murray Sterling, GENESIS Engineers, Inc.
Gordon Leichter, Pharmadule, Inc. Staff Project Manager: Carol Winfield
COP Council (COPC)
Role: To provide oversight and strategic leadership in the development and growth of ISPE Communities of Practice. Chairs*: Damian Greene, Pfizer Inc
Linda McBride, Enturia Inc Staff Project Manager: Scott Ludlum
Europe Affiliate Council (EAC)
Role: Recommend policies and procedures to the International Board of Directors for European Affiliates that will improve affiliate services to Members. Chairs*: Philippe Robin, Jacobs France
Nigel Frost, Thermal Transfer Ltd Staff Project Manager: Elmarie Herloff-Petersen
Europe Education Committee (EEC)
Role: Develop and produce a full curriculum of high quality, cost efficient Continuing Education programs for Europe that meet ISPE's Strategic Plan and the needs of the industry. Chairs*: Berthold Duethorn, Robert Bosch GmbH
Jan Gustafsson, Novo Nordisk A/S Staff Project Manager: Eralda Azizaj
Facility of the Year Committee (FOYC)
Role: Establish the Facility of the Year Awards competition as the most widely acknowledged and premier global award recognizing state-of-the-art pharmaceutical manufacturing projects utilizing innovation and technology to reduce the cost of producing high quality medicines. Chair*: Clive Mullins, Foster Wheeler Staff Project Manager: Scott Ludlum
International Education Executive Committee (IEEC)
Role: Act as an advisory board for the North America and Europe Education Committees, the Training Advisory and Technology-Based Learning Committees to develop and produce a full curriculum of high quality education programs within the Society's Body of Knowledge. Additionally, the IEEC is the forum to share best practices and foster synergy between ISPE's various education offerings. Act as an advisory council for the development of major themes and approaches for ISPE education 12-18 months out. Specifically, look at the current industry environment and technical and scientific learning needs for basic/intermediate/advanced professionals to create over-arching themes for ISPE's conferences/Annual Meeting (and other education programming as needed). Chairs*: Nuala Calnan, Calnan Pharma Consulting
Paul Crissman, Biotechnical Solutions Staff Project Manager: TBD
ISPE International Leadership Forum (ILF)
Mission : To provide an opportunity for thought leaders in the Pharmaceutical Industry to identify and influence direction and align the industry globally, establish dialogue with regulators to discuss critical technological issues, identify opportunities for innovation, promote consistency, and seek worldwide harmonization where appropriate.
*Chair: Thomas Zimmer, Boehringer Ingelheim Gmb Staff Project Manager: Bob Best
JPI Editorial Advisory Board (JPIEAB)
Role: Provide guidance, expertise, and counsel to ensure that the content of the Journal of Pharmaceutical Innovation provides relevant, science-based innovative articles in the areas of pharmaceutical science, product development, manufacturing technology, and quality systems. In order for JPI to meet its mission, the EAB will be responsible for facilitating the double-blind peer review process. Chairs*: Jim Drennen, Duquesne University
Stephen Scypinski, Bristol-Myers Squibb Staff Project Manager: Gloria Hall
Membership Services Committee (MSC)
Role: Evaluate membership services and recommend enhancements in order to increase membership base and minimize turnover. Chairs*: Dave Novak, AMEC
Gordon Lawrence, Novartis Pharma AG Staff Project Manager: Linda Brady
Nominating Committee
Role: Select the best-qualified representatives from among the full, active international membership to serve as candidates for the International Board of Directors. Chair*: Bruce Davis, AstraZeneca Staff Project Manager: Bob Best
North America Education Committee (NAEC)
Role: Develop and produce a full curriculum of high-quality Continuing Education programs for North America and South America that meet ISPE's Strategic Plan goals and the needs of the industry. Chairs*: Tim Howard, Commissioning Agents, Inc.
Allan Pfitzenmaier, Vectech Pharma Consultants Inc Staff Project Manager: Ginger Phillips
North America South America Affiliate Council (NASAAC)
Role: Recommend policies and procedures to the International Board of Directors that will improve Affiliate and Chapter services to Members. Chairs*: Donna DeFreitas, Siemens Buildin
Doug Hoover, Turner Pharmaceutical Staff Project Manager: Lynne Richards
Pharmaceutical Engineering Committee (PEC)
Role: Identify topics of current interest, seek author leads and information sources to enhance content of magazine, Web site, E-letters, and other communication media. Chairs*: Phil Pursifull, Commissioning Agents, Inc.
Cathy Middelberg, Wyeth Laboratories
Nissan Cohen, Start-Up Business Development Staff Project Manager: Gloria Hall
Professional Certification Commission (PCC)
Role: Develop and administer valid, reliable, and defensible credential programs approved by the ISPE Board of Directors. Chair*: Steve Williams, Seer Pharma Pty Ltd Staff Project Manager: Jerry Roth
Regulatory Affairs Committee (RAC)
Role: Help develop or maintain relationships with appropriate Regulatory Authorities' Agencies worldwide, serve as a regulatory interpreter, and recommend new projects for ISPE's role as “integrator”. Chair*: Bob Baum, Pfizer Inc Staff Project Manager: Alison Matherly
Student Development Committee (SDTT)
Role: Introduce ISPE to university students internationally and promote the life sciences as a profession to the next generation. Assist ISPE Affiliates and Chapters in establishing and maintaining student chapters and programs around the world. Chairs*: Jonathan Savona, Accuspec, Inc.
Greg Banks, Banks Integration Group, Inc. Staff Project Manager: Lynne Richards
Suppliers Advisory Council (SAC)
Role: Provide a mechanism to integrate service community talents, skills, and experience through a stronger, fuller professional partnership with the pharma industry to help the Society reach its strategic goal as catalyst for change for leading innovation. Chairs*: Andy Signore, IPS
Ole Spang-Hanssen, NNE PharmaPlan Staff Project Manager: TBD
Technical Documents Committee (TDC)
Role: Oversee the development of all Society guidance for Industry, utilizing personnel from industry, regulators, and suppliers. Chairs*: Brian Lange, Merck & Co, Inc.
Jan Gustafsson, Novo Nordisk A/S Staff Project Manager: Gloria Hall
Technology-Based Learning Committee (TBLC)
Role: Develop recommendations for appropriate technology for ISPE to pursue in delivering its educational products as well as consider most useful and timely technical content. The recommendations will include the parameters to be met from a format standpoint to ensure optimal adult learning. The committee will support the TAC, NAEC, and EEC as they build curriculum that is appropriate under the parameters for technology-based learning. Chairs*: Bo Crouse-Feuerhelm, AMEC
Bill Deckert, BE&K Building Group Staff Project Manager: Rae Hayward
Training Advisory Committee (TAC)
Role: This committee, in coordination with the IEEC, will direct a full curriculum of high quality training programs that meet ISPE's Strategic Plan and support the Society's Body of Knowledge. Chairs*: Dave DiProspero, Stantec Consulting Group, Inc
Jeri Weigand, Medtronic Corporate Quality & Audit Staff Project Manager: Ali Montes
University Relations Committee (URC)
Role: Foster academic perspectives, linkages, and programs in support of ISPE's business activities and initiatives. Chairs*: Colman Casey, University College Cork
Scott Tiedge, Alphabio Inc Staff Project Manager: Ali Montes