ISPE Code of Conduct

Member Code of Conduct

As a Member of ISPE, I will uphold the following values to the best of my ability:

• Collaboration in the pursuit of ISPE’s mission to be the leading technical organization for professionals engaged in producing quality medicines and pharmaceutical devices throughout the lifecycle.
• Ethical behavior that is worthy of trust, respect and admiration from others internally and externally.
• Professionalism characterized by behaviors and communications that are honest, fact-based and politically neutral; demonstrating courtesy and consideration toward other people; adhering to high standards and integrity in all that I do; and engaging in constructive problem-solving.
• Inclusiveness that allows for active and rewarding participation by other Members working throughout the global bio/pharmaceutical supply chain.

I will at all times abide by and conform to the following Code of Conduct:

1. I will obey all applicable laws and regulations of the relevant government authorities while acting on behalf of ISPE or representing myself as a Member of ISPE.
2. I will only use ISPE’s marks, insignia, name, logos and trade dress (collectively, “ISPE Marks”) in compliance with guidelines issued by ISPE from time to time.
3. While participating in ISPE events or representing myself as a Member of ISPE, I will not engage in disruptive, inappropriate, verbally or sexually harassing behavior toward others, and I will observe the personal boundaries set by others.
4. I will comply with all applicable copyright and intellectual property laws, and I will adhere to any related guidelines issued by ISPE from time to time.
5. I will respect the data privacy of other Members. Therefore I will take no action to gather or “harvest” Member contact information in bulk from ISPE’s Member database/directory and distribute that information to others for any reason.
6. I will not represent myself or my company using ISPE’s name in such a manner as to imply endorsement by ISPE in order to advance personal or company sales, leads or other gain.
7. If I choose to volunteer with ISPE, I will become familiar with and follow ISPE’s policies, procedures, guidelines and the Volunteer Code of Conduct while acting on behalf of the Society.

I understand that my acceptance of this Member Code of Conduct is applicable to the full duration of my membership regardless of whether my membership is maintained on a consistent or intermittent basis. I further understand that failure to comply with this Member Code of Conduct could result in sanctions up to and including loss of Membership and/or legal action depending upon the nature, severity and material impact of the violation.

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Member Communications & Interactions with Health Authorities Code of Conduct

The purpose of this document is to provide a protocol for interactions and communications with health authorities by ISPE members during the conduct of ISPE business.

The ISPE Regulatory Affairs staff department acts as the clearinghouse for interactions with health authorities, providing support where needed and guarding against situations where multiple individuals might approach a regulator with the same – or a conflicting – request.

Contact the ISPE Regulatory Affairs Department with any questions related to communicating or interacting with regulators and health authorities not answered by this document.

General Expectations

• Members will act in accordance with the ISPE Member & Volunteer Code of Conduct.
• Members may not make commitments for projects, initiatives, or work products on behalf of ISPE.
• Members will refrain from using ISPE interactions with regulators to promote personal business objectives, or to solicit regulatory policy judgments on a specific product/facility.

Meetings and Communications

• All initial communications with health authority representatives regarding any ISPE undertaking, planned or in progress, require advance discussion and coordination at the senior level, i.e., by the ISPE CEO who may consult with the Regulatory Steering Council (RSC), senior staff, or others. Such communications require broad awareness of ISPE’s strategic direction and plans, endorsed positions, and the ability to make commitments on behalf of the Society when appropriate.
• In cases where an ISPE volunteer group has made initial contact via the above process and has established communication with a regulator(s), the RSC should be informed of further or continuing communications with the regulator(s).
• Informal conversations that promote ISPE as a thought leader and go-to organization for technical knowledge are encouraged. Examples include:
  • Conversations during the planning and delivery of conference sessions where the regulator is speaking, roundtable discussions during conference sessions, informal hallway or podium conversations at conferences.
  • Informal conversations held during ISPE committee meetings in which a regulator is a member or an invited guest.

Interactions with Defined Processes

The following interactions are managed by ISPE staff in conjunction with designated committees.

• Requesting Regulatory Speakers
  • For ISPE International Events (face-to-face or virtual)
    • ISPE International submits all official speaker requests.
    • In some situations, an informal outreach in advance of the official request can help achieve the desired outcome. However, it must be made clear that it is an informal inquiry to gauge the regulator’s interest and availability and that the official request from ISPE will be submitted per the health authority’s procedures.
    • Informal outreach should be limited to regulators who are existing acquaintances of the member making the inquiry.
    • Before any informal outreach is made, contact ISPE International conference staff to confirm that a regulatory speaker has been planned for the session or event. Inviting a regulator to speak may incur costs. Inform the ISPE International conference staff of the regulator being contacted.
  • For ISPE Affiliate and Chapter Events (face-to-face or virtual)
    • All requests for speakers from the following agencies will be made by ISPE International. Affiliates and Chapters complete a Regulatory Speaker Request form, which can be found on the Affiliate & Chapter Resources page, and submit it to regulatory@ispe.org
      • Europe Commission (EC), European Medicines Agency (EMA), Heads of Medicines Agency (HMA)
      • International Conference on Harmonization (ICH)
      • Pan American Health Organization (PAHO)
      • Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-Operation Scheme (PIC/S)
      • US Food and Drug Administration (FDA)
      • World Health Organization (WHO)
  • Affiliates and Chapters can request speakers directly from local/country health authorities in the geographic region covered by the Affiliate/Chapter (other than those listed above) and must inform the ISPE Regulatory Affairs team at regulatory@ispe.org of the request.
  • To request a speaker from any agency outside of their country, Affiliates and Chapters complete a Regulatory Speaker Request form and submit to the ISPE Regulatory Affairs team at regulatory@ispe.org The ISPE Regulatory Affairs team will coordinate the request with the Affiliate located in the country of the agency being requested.
  • Once the request is submitted, the Affiliate or Chapter can indicate the agency as "invited" in the event advertising prior to receiving a confirmation from the regulator.
• Requesting Review of an ISPE Guidance Document (Baseline Guide, Good Practice Guide, etc.):
  • ISPE International submits all official review requests.
  • Decisions regarding regulatory review of ISPE Guidance Documents are made during the document proposal and development process. Contact the ISPE Publications Department for all matters concerning ISPE Guidance Document reviews.
• Providing Comments to Health Authorities on Documents Released for Public Comment/Consultation:
  • ISPE’s commenting process is overseen the Regulatory Quality Harmonization Committee (RQHC):
    • The RQHC determines whether the document falls within the scope of ISPE commentary.
    • A team of subject matter experts is convened to lead the comment development
    • Final comments are vetted by ISPE regulatory leadership prior to submission.
  • The Regulatory Quality Harmonization Committee welcomes inquiries from ISPE members or groups who wish to comment on a document through ISPE. Contact the ISPE Regulatory Affair Department with inquiries.

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Volunteer Code of Conduct

It is the policy of ISPE that anyone who accepts a Volunteer role in this Society must affirm his or her understanding of the expectations in this Code of Conduct and agree to abide by the decisions of the CEO (or Board if applicable) in its interpretation and implementation.

ISPE is a Society of individual Members. Hence, this Code of Conduct applies to individuals and does not in any way imply or construe obligations upon Members’ employers, regardless of the means by which membership dues are paid.

General Expectations

1. Volunteers will contribute to a collegial, inclusive, positive and respectful work environment for fellow Volunteers, stakeholders and staff, and they will model the best in professional behavior.
2. Volunteers will know, understand and support ISPE’s mission, core purpose, values, goals, strategies and annual directives. They will also become familiar with and follow ISPE’s policies, procedures, guidelines and the Volunteer Code of Conduct while acting on behalf of ISPE.
3. Volunteers will not discriminate and will be respectful of ethnic, national and cultural differences.
4. Volunteers will only use ISPE’s marks, insignia, name, logos and trade dress (collectively, “ISPE Marks”) in compliance with guidelines issued by ISPE from time to time.
5. Volunteers will obey all applicable laws and regulations of the relevant government authorities, including all laws and provisions that govern appropriate conduct in the workplace while acting on behalf of ISPE.
6. Volunteers will make or recommend decisions in the best interests of ISPE as a whole rather than focusing on any ISPE subpart or advocating options that advance a personal concern.

Meetings and Communication

1. While acting on behalf of ISPE, professional behavior and respectful discourse is required of Volunteers. Disruptive, inappropriate or harassing behavior toward other Volunteers, stakeholders or staff is unacceptable.
2. Personal boundaries set by others must be observed. Sexual harassment including but not limited to unwelcome sexual advances, requests for sexual favors and other verbal or physical harassment of a sexual nature will not be tolerated.
3. Only information deemed for public knowledge may be shared or discussed outside ISPE, unless specifically authorized to do so by the President/CEO and/or the Board Chair. No Volunteer will share, copy, reproduce, transmit, divulge or otherwise disclose any confidential information related to the affairs of the Society.
4. Volunteers will uphold strict confidentiality regarding any information discussed at meetings or in the course of any other deliberations and communications. Questions regarding the confidential nature of ISPE information or documents will be directed to the appropriate staff person or Board member.
5. Volunteers may not speak on behalf of ISPE or the Board to external parties such as the media or other interested individuals/entities unless specifically asked to do so by the President/CEO. 
6. Volunteers may not speak as subject matter experts on behalf of ISPE internally or externally unless authorized to do so in accordance with ISPE procedures.
7. All contractual agreements are the responsibility of ISPE staff in accordance with established authority and procedures. Volunteers cannot make contractual commitments on behalf of ISPE with the exception of Board officers formally granted such authority by the Board’s policies.
8. All ISPE correspondence, regardless of the medium, is a reflection on the Society. E-mail communications will follow the same professional standards as verbal communication. Emails may be considered legal documents, and therefore, caution must be exercised when recording written opinions and statements pertaining to the role of any ISPE Volunteer(s) or groups. The use of the “blind copy” function is strongly discouraged when conducting official ISPE business.
9. Volunteers will be supportive in communicating about ISPE to other Volunteers, Members and stakeholders. Inappropriate communication by e-mail or in any public forum about ISPE, its Volunteers, staff, stakeholders, policies, procedures or guidelines is not acceptable. Issues regarding ISPE will be taken up in private with the appropriate ISPE staff member. 
10. Participation in committee meetings (in-person and/or teleconferences as determined by each committee) is typically required to fulfill a Volunteer’s duties.

Relationship with Other Volunteers, Stakeholders and Staff

1. Volunteers may not attempt to exercise individual authority over their respective volunteer groups, nor may they purport to represent the organization or their respective volunteer groups to other ISPE volunteers, stakeholders or staff, except as explicitly set forth in ISPE’s Governance and Volunteer Operations Manual.
2. Volunteers will understand the scope of their authority and exercise good judgment in their dealings with other Volunteers, stakeholders, staff, suppliers and the general public. Accordingly, volunteers will respond to all Members and stakeholders in a prompt, responsible, respectful and professional manner, and they will represent their role within ISPE clearly and accurately.
3. Volunteers will not request special/personal favors or confidential/embargoed information from other Volunteers, stakeholders or staff without prior consultation and agreement of the President/CEO.
4. ISPE events are professional gatherings and therefore appropriate behaviors are expected. Volunteers will adhere to ISPE policies, procedures, guidelines and the Volunteer Code of Conduct in all interactions with other Volunteers, stakeholders, staff, vendors and other constituents.
5. Volunteers do not have direct authority over staff and do not have authority to delegate actions to staff without the approval of the appropriate ISPE manager.

Avoiding Conflict of Interest

1. No Volunteer will use any information provided by the Society or acquired as a consequence of the Volunteer’s service to the Society in any manner other than in furtherance of his or her volunteer duties. Furthermore, Volunteers will not misuse Society property or resources. They will at all times keep the Society’s property secure and will not allow any person access to such property unless authorized by ISPE.
2. Volunteers will not persuade or attempt to persuade any Member, exhibitor, sponsor, supplier, contractor or any other person/entity with an actual or potential relationship with the Society to terminate, curtail or not enter into that relationship. Further, Volunteers will not take any action that would serve to reduce the monetary or other benefits to ISPE of such relationship(s).
3. Volunteers are expected to act at all times in the best interest of the Society and not for personal or third-party enrichment.
4. When encountering a potential conflict of interest, Volunteers will identify the conflict and report it to the staff member assigned to the committee or project. If an actual conflict of interest is determined to exist, the Volunteer may be asked them to remove him- or herself from all discussions and voting on the matter.
5. Volunteers will not accept gifts, gratuities, free trips, honoraria, personal property or any other item of value from any person or entity as a direct or indirect inducement to provide special treatment to such donor on matters pertaining to the Society without fully disclosing in advance such items to the staff member assigned to the committee or project.
6. Volunteers will not represent themselves as ambassadors, experts or project leaders using ISPE’s name in such a manner so as to imply or advance personal or company sales, leads or other gain.

Volunteer Commitments

1. Volunteers will carry out volunteer duties in accordance with ISPE procedures and adhere to project timelines to which they have agreed.
2. In the event that a Volunteer realizes that s/he cannot fulfill a commitment, s/he will notify the responsible staff project manager or volunteer leader proactively.
3. Volunteers will recognize and be respectful of the fact that staff project managers have deadlines and may on occasion find it necessary to replace or augment volunteer resources.
4. Volunteers will relinquish project responsibilities promptly when requested if doing so is deemed to be in the best interests of the Society.

Confidential Materials, Intellectual Property, Work in Progress and Data Ownership

Upon termination of service, Volunteers will promptly return to the Society all documents, electronic and hard files, reference materials and other property not already on file in the ISPE office. Such return will not abrogate him or her from the continuing obligations of confidentiality with respect to the information acquired as a consequence of his or her tenure as a Volunteer.

Violations of the Code of Conduct

1. ISPE staff will resolve any issues with Volunteers in a professional manner.
2. If issues or violations of the Code of Conduct are persistent or egregious, Volunteers may be required to leave their volunteer position(s) and may be precluded from serving in volunteer roles in the future. Except in cases pertaining to the Board of Directors, the CEO will determine if this action is necessary and will notify the Volunteer. In cases pertaining to the Board of Directors, the Executive Council will determine if this action is necessary and will designate one of its Members to notify the Board Member.
3. Non-Board Volunteers who have been removed from a volunteer position have 30 days to appeal the decision to the Executive Council of the Board. The Executive Council will review the situation and respond within 30 days of the request for appeal. All decisions of the Executive Council are final.
4. ISPE reserves the right to pursue additional measures up to and including legal action in extreme cases where the actions of a Volunteer may have compromised ISPE’s mission, reputation, business prospects or legal stature.

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Virtual Events Code of Conduct

ISPE is committed to providing a safe, productive, and welcoming environment for all meeting participants. All participants, including, attendees, speakers, volunteers, exhibitors, service providers, and all others are expected to abide by this Virtual Programs Code of Conduct. This Policy applies to all ISPE meetings and events. 
ISPE has zero-tolerance for any form of discrimination or harassment by participants or our staff at our meetings.   
Unacceptable behavior is defined as:

• Harassment, intimidation, or discrimination in any form.
• Verbal abuse of any attendee, speaker, volunteer, exhibitor, service provider, or other meeting guest.

Examples of verbal abuse include, but are not limited to, verbal comments related to gender, sexual orientation, disability, physical appearance, body size, race, religion, national origin, inappropriate use of images in public spaces or in presentations, or threatening or stalking any attendee, speaker, volunteer, exhibitor, service provider, or other meeting guest.

Disruption of presentations during sessions, in the exhibit hall, or at other events organized by ISPE. All participants must comply with the instructions of the moderator and any ISPE virtual event staff.

Presentations, postings, and messages should not contain promotional materials, special offers, job offers, product announcements, or solicitation for services. ISPE reserves the right to remove such messages and potentially ban sources of those solicitations.

Participants should not copy or take screen shots of Q&A or any chat room activity that takes place in the virtual space.

ISPE reserves the right to take any action deemed necessary and appropriate, including immediate removal from any event without warning or refund, in response to any incident of unacceptable behavior, and ISPE reserves the right to prohibit attendance at any future event, virtually or in person.

The ISPE Code of Conduct related to Members and Volunteers also applies.