Orientation for ISPE China Volunteers Orientation Contents Society Basics: Who We Are and What We Do Volunteers & Staff Volunteers and Staff Project Managers roles Three Primary Responsibilities of SPMs Project Managers Relationship between chairs and SPMs Recruiting Volunteers Channels Procedure Expectation Benefits Dismissal Volunteer committee member Committee activities Responsibilities Code of Conduct Others: orientation, succession planning ISPE China Staff Team Society Basics: Getting to Know ISPE • Founded in 1980 • Not-for-profit, non-lobbying global professional society • 22,000 individual Members from more than 90 countries • Technical Professionals in Manufacturing and Drug Development Sectors of Pharmaceutical Industry • Provides technological knowledge, education, and guidance documents • Provides forums for exchange among industry, suppliers, academia, and regulators 3 Who Are ISPE’s Members? Global pharmaceutical professionals who work in every aspect of the pharmaceutical industry How Does ISPE Assist its Members? ISPE provides: • Access to regulatory and industry news, information and resources • Practical application education and training • Skills and knowledge for the future • Global and local networking opportunities Society Basics: ISPE’s Role • Connecting People Chapters, Affiliates, COPs, Conferences, Training, ISPEAK, Newsletters • Collecting, creating, and communicating knowledge Baseline Guides, Good Practice Guides, Pharmaceutical Engineering Magazine, Webinars, etc. • Building a better world ILF, Partnerships with groups such as ICH, PIC/S, Student Chapters Society Basics: ISPE Staff and Volunteers • Staff 50+ full time staff North America 5 China • Volunteers 2000+ Society Basics: What ISPE Volunteers can do • Speakers • Pharmaceutical Engineering Authors and Reviewers • Technical Document Translation Reviewers • Committees, Councils, and Task Teams • Communities of Practice • Affiliate/Chapter Activities • Ad Hoc Volunteer Opportunities • Technical Articles Contribution Society Basics: ISPE China Structure ISPE China Organizational Chart Volunteers and ISPE Staff Roles VOLUNTEERS are responsible for “who” and “what” aspects of Society programs. ISPE Staff Project Managers are responsible for “where,” “when,” and “how” - Volunteers are the strategic leaders of the Society SPMs are the operational leaders of the Society Three Primary Responsibilities of Staff Project Managers Administration Strategic Support Coordination of an annual schedule of face-to-face meeting sessions and teleconferences Ensures that committee has annual business goals in place Assisting with the compilation and distribution of agendas, meeting minutes, and ancillary meeting documents Communicates with committee leaders of any difficulties to accomplish annual goals Committee registrations Alerts committee members about other ISPE collaborative opportunities Monitoring changes to committee members contact information Tracking of action items and due dates Ensures committee projects are aligned with ISPE’s mission and vision Process Improvement Support Continuously analyze existing operating procedures to recommend and implement more effective processes Assists committee leaders to recruit, retain, and evaluate committee members’ contributions and effectiveness Relationship between Chairs and ISPE SPMs • Identify Annual Projects • Develop Teams for the completion of the Annual Project • Supervise and evaluate projects • Identify crossover projects with other committees • Develop meeting agendas • Facilitate Committee Meetings and Teleconferences Strategic (Chair) • Document and track Annual Projects • Coordinate all annual projects to the Committees • Generate evaluated reports on a project • Coordinate and schedule training session for new Committee members • Provide update on ISPE activities and other committee projects • Schedule Committee meetings, distribute agenda and minutes Tactical (SPMs) Recruiting Volunteers: Channels • • • Volunteer profiles received daily from Web site (see next page) Referrals/recommendations from existing Volunteers Customize messages to different Volunteer groups (young professionals, Retirees, and those with extensive experience) Recruiting Volunteers: Procedure SPMs complete volunteer position description and submit it to volunteer services Volunteer Service works with website staff to post the position description to website and reviews submitted profiles Volunteer Service verifies membership status and sends potential matches to SPMs for review SPMs forward and consult with Chairs to determine if there is a potential match for prospective volunteer If a volunteer match is made, SPMs notify volunteer service and volunteer service to responds to potential volunteer Once prospective volunteer confirms interest, volunteer service sends welcome letter, confidentiality agreement, general information on ISPE volunteer, etc. SPMs coordinate with volunteer services to provide orientation and training to new volunteers SPMs contact new volunteer to invite to the committee/task team meeting or teleconference If a match is not made, SPMs notify volunteer services so volunteer services can look for other opportunities relevant to interests and areas of expertise Alternatively, SPMs contact volunteer services if they are in need of ad hoc volunteers If an open position has not been filled 3months after the Call for Volunteers a specific message will be sent out seeking Volunteers for unfilled open position Recruiting Volunteers: Expectations Volunteer Expectations: Actively participate in meetings Read materials and come prepared to each meeting Listen to people and ideas Become knowledgeable of the Society’s policies and procedures Complete assignment on time Respond to communications in a timely manner Develop a good relationship with staff Respect confidentiality Fully support all decisions of the Board and Committee Always act in the best interest of ISPE Recruiting Volunteers: Benefits To become ISPE volunteer, you are eligible to take advantage on: Communication and networking with industrial people To get to know ISPE cutting-edge knowledge by means of helping ISPE to translate and review technical publication To get circulated by ISPE website, e-Newsletter, Weibo, etc. To take part in forum as well as other event with ISPE identity Management skills Member of year Recruiting Volunteers: Dismissal of a Volunteer • Volunteers who do not adhere to the rules and procedures of the organization or who fail to satisfactorily perform their volunteer assignment are subject to dismissal. • No Volunteer will be terminated until the Volunteer has had an opportunity to discuss the reasons for possible dismissal with [leaders]. • Possible grounds for dismissal may include, but are not limited to, the following: gross misconduct or insubordination, being under the influence of alcohol or drugs during non-social events theft of property or misuse of organizational equipment or materials abuse or mistreatment of other Volunteers or staff failure to abide by organizational policies and procedures failure to meet physical or mental standards of performance failure to satisfactorily perform assigned duties Volunteer Committee Member: Committee Activities Face-to-Face Meetings – takes place at ISPE China annual conference ISPE developed other alternatives to hold committee meetings with minimum travel requirement. Teleconference/Virtual Meetings – schedule for this meeting is determined by committee members Committee Initiatives Volunteer Committee Member: Responsibilities • • • • • • • • Help identify work streams and work products that will be of benefit to ISPE and to the industry in general Facilitate committees, interaction with fellow volunteers, identify and select resources, assign tasks, and manage individuals and their contributions to advance the objectives of the Society as outlined in the Strategic Plan and the Business Plan Evaluate Committee performance and take corrective actions Prepare for and actively participate in committee meetings and the completion of your Volunteer assignment Read materials and come prepared to each meeting Become knowledgeable about the Society’s policies and procedures by participating in Volunteer orientation Complete assignments on time and notify ISPE staff members when delays are inevitable Respond to written and verbal communication in a timely manner Volunteer Committee Member: Code of Conduct • • • • • • • • Serve as positive representative of ISPE and your committee by conducting yourself in an informed, appropriate, and professional manner Acknowledge and respect other Volunteers and ISPE Staff members’ contributions, talents, efforts, and dignity Commit to developing a strong working relationship with your ISPE staff project manager (or any staff members you interact with) and treat with dignity and respect Be courteous and respectful of the opinions of others Participate in open and honest communications and discussions in a responsible and respectful way Present suggestions, ideas, opinions, and disagreement in a positive and productive manner Treat as strictly confidential all personal discussions with ISPE staff and other Volunteers, all written correspondence and documents (including emails, business plans, meeting minutes, etc.) and all discussions taking place in committee meetings and conference calls Be willing and able to put ISPE first and commit to not engaging in inappropriate commercialism or self-promotion Volunteer Committee Member: Orientation • SPMs are responsible for volunteer orientation • Provides general information about ISPE, the roles and responsibilities of being an ISPE Volunteer, and information about the specific Volunteer position • Customized orientation materials available for different Volunteer groups (Chairs/Co-Chairs, objectives, business plan, etc.) Volunteer Committee Member: Succession Planning • SPMs participate in annual committee evaluation with the Board. • SPMs communicate with Chairs/Co-Chairs about: • Chairs/Co-Chairs for upcoming year • Potential candidates for future Chair/Co-Chair positions • Composition of the committee (number of active members, areas of industry represented, geographic balance, recruiting new committee members) • SPMs work with Volunteer Services to recruit new committee members ISPE China Office Staff Jackie Liu --- ISPE China Affiliate Relations Manager Staff Project Manager to Board of Directors/Executive Council/Conference committee Email: jliu@ispe.org Tel: 021-23123513 Melody Hu --- ISPE China Event Executive Training Committee/Chemical Drug Product and Process Committee/Clinical Supply Committee Email: chinaevent@ispe.org Tel: 021-21323641 Helen Jiang --- ISPE China Membership Service Executive Student & Young Professionals Committee/Regulatory and Compliance Committee/Membership Development Committee/ Manufacturing & Engineering Committee ISPE Membership Applications, Guidance book purchasing & other inquiries Email: hjiang@ispe.org Tel: 021-23123640 ISPE China Office Staff Other Supporting Staff: Vivi Gu --- ISPE China Marketing&Communication Coordinator Biological Drug Product and Process Committee Email: china@ispe.org Tel: 021-23123517 Amanda Yang --- ISPE China Sales Executive Email: china@ispe.org Tel: 021-23123518 Thanks for Your Support of ISPE Please contact china@ispe.org should you have any questions.