Role: Recommend policies and procedures to the International Board of Directors that will improve services to Members in the region. Chair: Roger Dowding, Merck Sharp & Dohme Board Liaison: Tomiyasu Hirachi Staff Project Manager: Rhonda Ng
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. Chair: Gordon Leichter, NNE Pharmaplan Co-Chair: Kevin Porter, Thermo Systems LLC Board Liaison: Charlotte Enghave 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. Chair: Damian Greene, Pfizer Inc Co-Chair: Linda McBride, Cogentus Pharmaceuticals Board Liaison: Damian Greene Staff Project Manager: Scott Ludlum
Europe Affiliate Council (EAC)
Role: Recommend policies and procedures to the International Board of Directors that will improve services to Members in the region. Chair: Nigel Frost, Thermal Transfer Ltd Co-Chair: TBD Board Liaison: Nigel Frost Staff Project Manager: Elmarie Herloff-Petersen
Europe Education Committee (EEC)
Role: Schedule and manage a full curriculum of high quality, cost efficient Continuing Education programs for Europe that meet ISPE's Strategic Plan goals and the needs of the industry. Chair: Berthold Duethorn, Robert Bosch GmbH Co-Chair: Jan Gustafsson, Novo Nordisk A/S Board Liaison: Nuala Calnan Staff Project Manager: Eralda Azizaj
Executive Council
Role: Provide strategic leadership for the Society, review operational issues for presentation to the International Board of Directors in summary form and act on behalf of the Board between meetings. Chair: Chuck Hoiberg, Pfizer Inc Board Liaison: Chuck Hoiberg Staff Project Manager: Bob Best
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 Board Liaison: Nigel Frost Staff Project Manager: Marni Schribman
Finance and Audit Committee
Role: Ensure integrity and financial accountability of ISPE and advise the Board on the direction and control of financial matters. Chair: Andre Walker, BiogenIdec Manufacturing ApS Board Liaison: Andre Walker Staff Project Manager: Victoria Smoke
Foundation Board
Chair: Bruce Davis, AstraZeneca Board Liaison: Bruce Davis Staff Project Manager: Victoria Smoke
International Board of Directors
Role: Create the Society's vision, establish its basic goals and policies, approve its financial direction and provide guidance to the committees, councils, task teams, COPs, and Professional Staff. Chair: Chuck Hoiberg, Pfizer Inc Board Liaison: Chuck Hoiberg Staff Project Manager: Bob Best
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: Sharon Bleach, AstraZeneca Board Liaison: Chuck Hoiberg 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. Chair: Jim Drennen, Duquesne University Co-Chair: Stephen Scypinski, Bristol-Myers Squibb Board Liaison: Charlotte Enghave Staff Project Manager: Gloria Hall
Membership Development Committee (MDC)
Role: Evaluate membership benefits and recommend enhancements to create value for ISPE Members. Recommend programs to enhance the membership for all Members worldwide. Chair: Gordon Lawrence, Novartis Pharma AG Co-Chair: Rick Pierro, Superior Controls Inc Board Liaison: Nigel Frost 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: Chuck Hoiberg, Pfizer Inc Board Liaison: Chuck Hoiberg Staff Project Manager: Bob Best
North America Education Committee (NAEC)
Role: Schedule and manage 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. Chair: Tim Howard, Commissioning Agents, Inc. Co-Chair: Allan Pfitzenmaier, Vectech Pharma Consultants Inc. Board Liaison: Stephanie Wilkins 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 services to Members in the region. Chair: Doug Hoover, Turner Pharmaceutical Co-Chair: John Holton, Cephalon Board Liaison: Andre Walker Staff Project Manager: Karleen Kos
PCC Appeals Committee
Chair: Steve Martin, B E & K Staff Project Manager: Jerry Roth
PCC Eligibility Committee
Chair: Chuck Stock, IPS Staff Project Manager: Jerry Roth
PCC Exam Development Committee
Chair: Patrick Asplund, Cook Pharmica Staff Project Manager: Jerry Roth
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. Chair: Phil Pursifull, Commissioning Agents, Inc. Co-Chair: Judy Samardelis, Wyeth Biopharma Board Liaison: Stephanie Wilkins Staff Project Manager: Gloria Hall
PQLI Science and Technology Committee (PQLI S&T)
Role: Enable the Society to act as integrator for all pharmaceutical disciplines to assist industry and regulators in advancing manufacturing sciences to achieve excellence in pharmaceutical production. Chair: David Selby, Selby Hope International Ltd Co-Chair: Gert Moelgaard, NNE Pharmaplan Board Liaison: Bruce Davis Staff Project Manager: Bob Best
President’s Advisory Council
Chair: Sharon Bleach, AstraZeneca Board Liaison: Chuck Hoiberg Staff Project Manager: Bob Best
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 Board Liaison: David Petko Staff Project Manager: Jerry Roth
Regulatory Affairs Committee (RAC)
Role: Help develop and maintain relationships with appropriate Regulatory Authorities worldwide, serve as a regulatory interpreter, and recommend new projects for ISPE's role as 'integrator.' Chair: Bob Baum, Pfizer Inc Co-Chair: Nirdosh Jagota, Wyeth Board Liaison: Chuck Hoiberg Staff Project Manager: Gina Chan
Resource Analysis Task Team (RATT)
Chair: Alan Mac Neice, Elan Co-Chair: Alan Jones, CRB Engineers & Builders Board Liaison: Alan Mac Neice Staff Project Manager: Scott Ludlum
Student Development Committee (SDTT)
Role: Introduce ISPE to university students internationally and promote the life sciences as a profession for the next generation. Assist ISPE Affiliates and Chapters to establish and maintain student chapters and programs around the world. Chair: Greg Banks, Banks Integration Group, Inc Co-Chair: Jennifer Lauria Clark, Yonkers Industries, Inc Board Liaison: Charlotte Enghave Staff Project Manager: Karleen Kos
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. Chair: Andy Signore, IPS Co-Chair: Ole Spang-Hanssen, NNE Pharmaplan Board Liaison: Nuala Calnan Staff Project Manager: Dave Hall
Technical Documents Committee (TDC)
Role: Oversee the development of all Society guidance for Industry, utilizing personnel from industry, regulators, and suppliers. Chair: Paul D’Eramo, Johnson & Johnson Co-Chair: Mel Crichton Board Liaison: Guy Wingate Staff Project Manager: Gloria Hall
Technology-Based Learning Committee (TBLC)
Role: Develop process for identifying content to be repurposed and/or developed and the prioritization for repurposing based on a member-centric approach to e learning. Develop recommendations for appropriate technology formats for ISPE to pursue in delivering its educational products based upon a standpoint of ensuring optimal adult learning. The committee will work with the TAC, NAEC, and EEC as they build curriculum that is appropriate under the parameters for technology-based learning. Chair: Bo Crouse-Feuerhelm, CH2M HILL Co-Chair: Bill Deckert, BE&K Building Group Board Liaison: Nuala Calnan Staff Project Manager: Rae Hayward
Training Advisory Committee (TAC)
Role: This committee will recommend a full curriculum of high quality training programs that meet ISPE's Strategic Plan and support the Society's Body of Knowledge. Chair: Jeri Weigand, Medtronic Quality Co-Chair: Dave Koncak, Pfizer Inc Board Liaison: Joan Gore Staff Project Manager: Ali Montes
University Relations Committee (URC)
Role: Foster academic relationships, perspectives, linkages, and programs in support of ISPE's strategic activities and initiatives. Chair: Joe Robinson, Commissioning Agents Co-Chair: Scott Tiedge, Alphabio Inc Board Liaison: David Petko Staff Project Manager: Ali Montes