GlobalizationIntegration of Clinical Materials Committee and Investigational Medicinal Products Grou

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Globalization/Integration of Clinical Materials
Committee and Investigational Medicinal Products
Group into Investigational Products (IP)
Community of Practice
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Globalization Team

• Joan Gore, chair CMC
• Bernd Steffens, chair IMPG
• Michelle Foust, vice-chair CMC
• Massimo Eli, vice-chair IMPG
• Michael Ku, past-chair CMC
• Scott Ludlum, ISPE

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ABOUT ISPE COMMUNITIES OF PRACTICE

• ISPE Communities of Practice (COPs) offer
  pharmaceutical manufacturing professionals a
  dynamic forum to gain relevant and timely
  information through discussions and networking
  opportunities. The purpose of ISPE COPs is
• Provide a forum for community members to help
  each other solve everyday work problems and
  engage in active networking
• Develop and disseminate best practices,
  guidelines, and procedures for use by community
  members
• Organize, manage, and research a body of
  knowledge from which Community members can draw
• Innovate and create breakthrough ideas,
  knowledge, and practices

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EXISTING ISPE COMMUNITIES OF PRACTICE

• Active Pharmaceutical Ingredients (API COP)
• Biotech (Biotech COP)
• Clinical Materials (CM COP)
• Commissioning and Qualification (CQ COP)
• Containment (Containment COP)
• Critical Utilities (CU COP)
• HVAC (HVAC COP)

• Investigational Medicinal Products (IMP COP)
• Good Automated Manufacturing Practice (GAMP COP)
• Process Analytical Technology (PAT COP)
• Process/Product Development (PPD COP)
• Project Management (PM COP)
• Sterile Products Processing (SPP COP)

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VALUE TO MEMBERS

• Opportunity to get actively involved and share
  knowledge and experiences with other like-minded
  professionals through convenient global
  networking forums
• Access to tools and resources to enhance
  productivity and keep current on industry trends
  and developments and do their jobs better
• Enhance productivity by contributing to the
  development of a community-specific Body of
  Knowledge
• Generate new knowledge and solutions in response
  to problems and opportunities
• Provide one central area for access to technical
  information related to specific disciplines
• Promote common language and terminology
• Contribute to pragmatic understanding and
  interpretation of industry regulations

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OPPORTUNITIES TO GET INVOLVED

• Participate on COP steering committee or
  subcommittees
• Speak at or contribute to developing community
  specific educational conferences
• Write and/or review articles for ISPE
  publications and COP E-Letters
• Get solutions from participating in global
  E-discussions with like-minded professionals
• Attend conference sessions as well as interactive
  general meetings for COP members
• Engage in numerous personal networking
  opportunities at ISPE conferences and training
  events worldwide and on-line

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COP COMMUNICATION TOOLS

• COP Web site www.ispe.org/cops
• Listserv E-Discussions www.ispe.org/listserv
• COP E-Letters www.ispe.org/eLetters
• COP Meetings and networking events
• Conferences and training

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Global IP COP Mission(Our purpose)

• The ISPE IP Community of Practice is the premier
  global organization providing relevant, timely
  and cutting-edge information and services, and
  access to solutions and resources to industry
  professionals worldwide with interest or
  professional experience in all aspects of the IP
  supply chain. This is accomplished through
• Dynamic forums to network and share common
  interests, current and best practices
• A web site providing a wealth of information and
  access to resources
• Real-time electronic discussions and
  e-newsletters
• Technical documents and best practice guides
• Interaction with regulatory bodies promoting a
  global harmonized point of view

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Global IP COP Vision(How we see ourselves in 3-5
years)

• The ISPE IP Community of Practice serves its
  global members as the primary resource for the
  best information and services. The COP
  continuously increases membership and involvement
  and leads the industry to new state of the art
  technologies and best practices.

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Global IP COP Value Proposition(How do we add
value?)

• The COP adds value to its members by
• Providing the best information and services
• The COP adds value to the industry by
• Allowing members to positively influence the
  profession by enabling participating individuals
  to identify and resolve professional issues
• Enabling innovation and adoption of new
  technology
• Promoting a common language and terminology
  within the discipline
• Promoting a global harmonized regulatory
  environment with pragmatic understanding and
  interpretation of industry regulations

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Services (to get to new technologies/best
practices)

• Website (as above)
• Listserv E-Discussions (as above)
• Cutting edge educational forums. For example
• Global Annual Meeting
• EU regional COP meeting annually
• Other regional meetings based on expansion plans
• Training events (courses, webinars etc.)
• Consider providing web-based training courses in
  languages other than English.
• Position papers
• Global technical/best practices guides
• Input into Regulatory information

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Outreach/Expansion

• New IP COP members
• Expansion into new regions of the world
• Requires analysis to determine next region for
  expansion (Asia?)
• Expansion into new local chapters particularly in
  the US
• Expansion of current customer base by providing
  excellent service and marketing.
• Expansion to new customers
• Devices Diagnostics Medical staff managing
  supplies at sites etc.
• Regulatory agencies
• Academia (students, staff)

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Processes Org Structure
Task Teams
Task Teams
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IP COP Council

• Consists of officers of all regional steering
  committees (chair, vice chair, secretary)
• Chairmanship will rotate through the regional
  steering committee chairs annually (US, EU,
  other)
• Meet at least four times per year with at least
  one face to face meeting (ISPE Annual Meeting,
  ISPE Leadership Meeting or other forum as decided
  by the Council)

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IP COP Council

• Responsible to
• Set global direction for the COP and ensure
  alignment of all activities
• Sanction/manage global committees (e.g.
  regulatory, Education, Communication, Annual
  Meeting, Outreach etc..)
• Committees should be global unless expressly
  approved by the Council
• Committees should include members of the general
  COP as well as RSC members. Committee chairs
  should identify required resources both within
  the RSC and the general COP
• Set and/or approve annual business objectives for
  Council and all Regional Steering Committees
• Manage all COP expansion activities (new Regional
  Steering Committees new local chapters, new
  customer groups)
• Maintain by-laws for Council and ensure by-laws
  are updated and appropriately aligned for all
  Regional Steering Committees.
• Serve as the primary link to ISPE headquarters
• Ensure appropriate representation on ISPE
  committees
• Manage COP finances

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Regional Steering Committees

• Responsible to
• Set objectives for local regional activities
• Lead/participate in global IP Committees as
  established by the IP COP Council
• Provide representation on ISPE general committees
  as directed by the IP COP Council
• Sanction/manage/lead local task teams as
  established by the RSC
• Task teams should include members of the general
  COP as well as RSC members. Task team chairs
  should identify required resources both within
  the RSC and the general COP
• Appoint a RSC member to liaise with any local
  chapters/regional/affiliate groups. The point
  person will stay in contact with the local group,
  ensure a strong connection to the RSC, ensure IP
  activities are communicated to the COP (including
  through the website), and report back on
  activities to the RSC and IP COP Council

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Subcommittees and Task Teams

• Global Annual Meetings Subcommittee
• Global Regulatory Subcommittee
• Education Subcommittee
• Communication Subcommittee
• Distribution Group Task Team
• Japan Clinical Supplies Group Task Team