ONE ISPE FAQs

For some time now, ISPE and its Affiliates/Chapters have collectively recognized the need to update the Charter that establishes the operational framework for ISPE Affiliates/Chapters.  The Charter essentially sets forth the conditions and business relationships for ISPE Affiliates/Chapters to operate under the ISPE brand, advancing ISPE’s Vision and Mission at regional and local levels across the globe as One ISPE.  Originally constructed some 12 years ago, the Charter has been updated periodically through piecemeal revisions. Still, until now, we have not taken a thoughtful, holistic approach to revise the document with the future in mind; a future of growth for ISPE on what we hope to be the heels of the global pandemic.

The pandemic has created a set of circumstances whereby ISPE and its International Board of Directors see tremendous opportunity and a moral responsibility to further connect pharmaceutical knowledge to a broader audience worldwide, and the ISPE Affiliates/Chapters are vitally important in that regard, working together as One ISPE.  We believe the current operating framework governing ISPE Affiliate/Chapter operations must be improved to accelerate and foster ISPE’s growth and further advance our Mission and the interests of our membership, the industry, and the patients served. 

Further, throughout the pandemic, many Affiliates/Chapters underwent significant financial hardship while others were able to maintain financial stability. The new Charter will better enable all Affiliates/Chapters to flourish together as One ISPE, and bring value to their local pharmaceutical communities with a backdrop of fiscal certainty. 

 

ISPE’s Mission and Vision Statements are as follows:

ISPE’s Mission Statement

“ISPE is the global industry leader in connecting pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence, and regulatory insights to enhance industry efforts to develop, manufacture and reliably deliver quality medicines to patients.”

ISPE’s Vision Statement

“Provide solutions to complex pharmaceutical industry challenges through manufacturing innovation, member, and workforce development, technical, regulatory, and compliance collaboration.”

ISPE aims to achieve this Mission and Vision by delivering critical pharmaceutical knowledge across the globe, and by providing platforms to enable meaningful and transparent conversations supporting industry improvement, harmonization, and the know-how for companies to accelerate the delivery of critical products and services – all towards enabling more transformational medicines to be available to worldwide patient populations. These principles can only be progressed with a centrally-coordinated, international effort operating synergistically with ISPE Affiliates/Chapters as One ISPE.

Embedded in the new Charter are the following principles, which will strengthen ISPE’s relationship with Affiliates/Chapters and better enable ISPE as a whole to achieve the organization’s Mission and Vision:

• Membership Retention & Growth Incentives that financially reward membership retention & growth for industry and student members for each Affiliate/Chapter.
• Expanded Affiliate Benefits package that includes an assigned ISPE Board Liaison to each Affiliate, digitally packaged ISPE International session videos from select events, an ISPE training course for use by the Affiliate, and comprehensive training for Affiliate Leadership.
• Affiliate/Chapter Growth Fund supported by contributions from ISPE International and Affiliates with gross revenues exceeding USD $50K, governed jointly by the International BOD and the Affiliate Council Chairs.
• Modified Affiliate Event Restrictions whereby geography limitations have been reduced for all conferences other than the ISPE Annual Meeting.
• New Governance Process for proposing future changes to the Charter.

These concepts will allow ISPE to expand its worldwide business, achieve its Vison and Mission, and provide an operating framework that fosters global growth, enabling synergistic value and encourages coordination between Affiliates and ISPE International – the embodiment of One ISPE.  

This is an exciting time in the pharmaceutical industry, and it represents an opportunity for ISPE to advance its interests under a stronger Affiliate and Chapter relationship model – a relationship evolved over the past 40 years and to be further advanced and built with trust, transparency, compliance, and synergistic prosperity. 

 

We hope that all Affiliates/Chapters will take full advantage of the benefits contained in the newly developed Charter. To accomplish this, Affiliates/Chapters must be in full compliance with the requirements contained in the Charter. Only those Affiliates/Chapters in compliance with the Charter will be eligible to receive the benefits set forth in the new Charter. To support this effort, ISPE International will provide a Roadmap To Success Checklist that will be made available in February 2022.  

All members of ISPE pay dues based on their regional grouping. When joining, each member is now required to choose an Affiliate or Chapter, which is generally based on their geographic location.

On 31 December of each calendar year and based upon the membership Affiliate/Chapter designation, ISPE International will determine the number of industry members for each Affiliate/Chapter based on enrollment information contained in our database at that time. The next year, this data will be compared with data from the prior 31 December (year-end) date. Financial rewards range from USD $2.00 to USD $11.00 per member with a gradient from 0% to greater than 7.5% growth. The details are provided in the Charter and referenced below. Payment reconciliation is made in July of the following year. As an example, if a Tier 1 affiliate with 500 members increased their membership by just 20 members (4% growth), the Affiliate would be entitled to receive a payment of USD $2,080 (540 x $4.00) from ISPE Headquarters. Industry Members are those paying the industry dues rate in every World Bank Tier.

Regarding incentives for students, each affiliate will receive USD $2.00 for each student registered within ISPE’s data base regardless of their Tier designation. Therefore, on 31 December, ISPE International will assess worldwide student membership and will provide financial reward for each student associated with a particular Affiliate/Chapter as defined in the data base. An increase in student members is not a requirement for this award. Payment reconciliation will occur in July of each year.

The first student and Industry Member financial reward payments will be made in July 2023, based upon the 31 December 2022 membership headcount.

Member Increase over Prior Year*	World Bank Tier 1 Membership Rate	World Bank Tier 2 Membership Rate	World Bank Tier 3 Membership Rate
7.5% or greater	$ 9.00	$ 10.00	$ 11.00
6% or greater	$ 7.00	$ 8.00	$ 9.00
4% or greater	$ 4.00	$ 5.00	$ 7.00
2% or greater	$ 3.00	$ 4.00	$ 6.00
0% or greater	$ 2.00	$ 3.00	$ 5.00
* Note: Industry Members only

Membership Revenue Share - Per Student Member
$2.00 per student member (as of roll taken on 31 December)

 

Growing the footprint and membership of ISPE is core to our mission and vision. This program allows all Affiliates/Chapters to apply for potential funding from the ACG fund.

The fund is held separately from all other ISPE funds and designated for the strict purpose of supporting ISPE’s global Mission and Vision.

Financial contributions to the ACG Fund are made by all Affiliates/Chapters with gross revenue over the equivalent of USD $50,000. Each qualifying Affiliate/Chapter will contribute 2.25% for each dollar of gross revenue over $50,000. As an example, if an Affiliate/Chapter has gross revenue of $400,000, their contribution would be $7,875 to the fund ($400,000-$50,000) x .0225). ISPE International then matches, dollar for dollar, the cumulative contributions made by all Affiliates/Chapters up to $100,000 each year. Based upon 2019 financial statements, it is expected that each year there should be approximately $200,000 available within the ACG Fund to advance ISPE’s Mission and Vision across the globe and support expansion of our international footprint while ensuring financial health of its Affiliates and Chapters. The first payment to the fund is in 2023 and will be based upon the Affiliates’/Chapters’ gross revenue from 2022. To seed this program, ISPE International will contribute $75,000 in 2022, and request that all Affiliates/Chapters make a voluntary (non-mandatory) contribution to the fund in 2022 if possible.

The ACG Fund will be administered by a Committee of seven ISPE Members as defined below. The Committee will meet a minimum of once per year and determine allocation of the ACG Fund. There will be a formal process for application and award of the funds.

• Asia Pacific Affiliate Council (APAC) Chair – voting member
• European Affiliate Council (EAC) Chair – voting member
• North America/South America Affiliate Council (NASAAC) Chair – voting member
• Three ISPE International Board Members to be named by ISPE Board Chair – all voting members
• ISPE Staff member – non-voting member

 

There will be a formal application process which will include additional context for Affiliate/Chapter Growth Fund awards. We expect the criteria to be fairly broad, noting that initiatives should be consistent with the ISPE International Strategic Plan, and fully aligned with ISPE’s Mission and Vision statements.  

Gross revenue is a directly measurable value that represents all revenue generated within an Affiliate/Chapter. Using any value other than gross revenue (net revenue for example), overly complicates the contribution calculation due to international tax codes, expense qualifications, and other accounting interpretations.  

ISPE International will seed an initial investment of USD $75,000 into the fund in 2022. After that, ISPE International will match the total contributions from all the Affiliate/Chapter annually up to USD $100,000 annually.  

The existing Charter imposes a number of restrictions on events, including size, dates, and location. Our intention was to ensure Affiliates/Chapters could benefit from relaxed restrictions in order to grow their local events; however, complete revocation of event restrictions limits will create unwarranted competition among ISPE’s major events for both ISPE International and Affiliates/Chapters. Hence, ISPE International recommended a model in which there would be modified event restrictions and a Gross Revenue Share component. Under this, any Affiliate/Chapter with a gross revenue of over USD $650K would pay a % over that amount to ISPE International. (This number correlates with the current Charter event restrictions applying a generous standard and increased to protect revenue generated outside of major events by the Affiliate/Chapter.)

Based on feedback from Affiliate/Chapter leaders, this evolved to a phased 2-tier approach with various gross revenue thresholds to minimize impact. Hence, there is a differentially short-term impact on Affiliate/Chapter with high event revenue, but the longer-term goal is to enable all to grow equally and in compliance with the Charter. Specifically, a phased approach over a 4-5 year period whereby the share portion was 5, 10, 15, 20% over the revenue years of 2022, 2023, 2024, 2025, respectively. However, the Affiliate/Chapter Ambassador group was not sufficiently supportive of removing the event restrictions in favor of the revenue share and therefore the concept was abandoned. This can be revisited in the future should the Affiliate/Chapter Ambassadors determine otherwise.

Regarding the basis for this revenue share component, ISPE International, on behalf of its members and member companies, drives for improving the opportunity for these groups to bring transformational medicines to patients across the globe. While local Affiliate/Chapter interests serve local markets and communities, international regulatory harmonization is achieved at the international level via multiple mechanisms that are not always reimbursable. Further, the development and execution of timely and relevant training programs, the management & publication of guidance documents, and conference venues and platforms to achieve our Mission and Vision are all very costly. ISPE international has a heavy financial reliance on our ability to secure a significant number of vendors to our exhibits that are coincident with our knowledge platforms. For these reasons, event restrictions were placed in the current Charter to remove any competition between the ISPE International and its Affiliates and Chapters. Our strong desire was to lift restrictions in favor of an above threshold revenue share. Again, this was not strongly endorsed by the Affiliate/Chapter Ambassadors. Therefore, modified event restrictions were maintained.

 

ISPE and its International Board of Directors grant, with restriction, the use of ISPE’s brands, logos, and intellectual property to ISPE Affiliates/Chapters to advance its worldwide business. The Charter, which establishes the rules and framework that must be followed as conditions for establishing and operating Affiliates/Chapters, is set forth by the International Board of Directors, which also has authority to make changes to the Charter. ISPE does not take this responsibility lightly and as evidenced by the establishment of the Ambassador group, survey administration, and engaging with Affiliates/Chapters throughout the change process, we have demonstrated a collaborative approach to this revision, thoughtfully advancing the new model and adjusting its contents where appropriate based on the feedback received. The ISPE Affiliate/Chapter Ambassador Committee was established to represent ISPE International and stakeholder groups, allowing for an open line of communication as the new Chapter elements were being developed and considered.  

Key milestones of the Charter rollout include the following:

• Each Affiliate/Chapter President/Chair, Vice-President/Co-Chair, Treasure, and Secretary received the new Charter for signature electronically via DocuSign on 14 January 2022.
• Affiliates/Chapters will receive a Roadmap To Success Checklist in February 2022. Affiliates/Chapters should review this checklist to ensure they are setup for success with reporting requirements.
• Affiliates/Chapters must electronically sign the Charter document no later than 15 March 2022.
• Affiliate/Chapter representatives must attend formal ISPE Charter training currently scheduled for the month of March 2022.

 

Based on 2019 financial information provided by the Affiliates/Chapters, ISPE International has developed estimates of what each Affiliate/Chapter would receive from revenue incentives for Industry and Students Members. Also, an estimate of each Affiliate/Chapter contribution (if any) to the Affiliate/Chapter Growth Fund has been developed. These are available to all Affiliate/Chapter leaders upon request.  

ISPE engaged a world-class non-profit association consulting organization to conduct research in early 2021 in which more than 150 Affiliate/Chapter leaders representing 38 Affiliates/Chapters participated through research surveys and focus groups.

In August 2021, a group comprised of ISPE International Board members and staff reviewed the research results, including conduct of a three-day workshop to incorporate the research results into the fabric of a new model. We also established an ISPE Affiliate/Chapter Ambassador Committee to represent ISPE International and stakeholder groups, allowing for an open line of communication as the new Chapter elements were being developed and considered. All the feedback received was evaluated and progressed where appropriate into a new draft Charter that was sent to all Affiliate/Chapter presidents for review. ISPE International provided a log of comments to all the Affiliate/Chapter leaders in December 2021.

 

Firstly, we want to thank each and every one of you for the time and dedication you spend as an ISPE volunteer. We understand that ISPE International must make it transparent and clear to understand what steps you must take in order to receive the benefits associated with the new Charter. To assist in tracking compliance, we will be scheduling individual meetings with representatives from each Affiliate/Chapter, providing a Roadmap to Success Checklist, and providing mandatory training for all Affiliates/Chapters.  

As part of the new Charter, ISPE will be implementing a Board Liaison program in which one ISPE International Board member will be assigned to each Affiliate/Chapter. Our hope is that this will address the desire for more interaction at the International Board level thus strengthening these relationships.  

As a benefit included in the new Charter, there will be one ISPE training course per year provided to each Affiliate/Chapter at the local level in an OnDemand format. This is a great opportunity for Affiliates/Chapters to earn additional income as they retain all revenue generated by the use of the training program.  

Upon compliance of the Charter, the Affiliate/Chapter will receive:

• Membership growth incentives
• ISPE Board Liaison
• Affiliate/Chapter Advisor Program
• Digitally packaged ISPE International session videos from select events
• One ISPE training course per year provided to offer at local level
• Annual Affiliate/Chapter Board Orientation and Onboarding for Affiliate/Chapter leader

 

As part of the One ISPE Initiative, Affiliates/Chapters who have a net increase of full industry members over the previous year will receive a portion of member dues for every industry member according to the schedule below. Additionally, all Affiliates/Chapters will receive USD $2.00 for each student member from their Affiliate/Chapter, regardless of the student member count in the previous year.

Only Affiliate/Chapters that are in compliance with the charter for the entire preceding year are eligible to participate in the membership financial compensation.

• Industry Members are those paying the industry dues rate in every World Bank Tier. It does not include students, recent graduates, academic, regulatory, and retired members.

Membership Revenue Share Schedule

Member Increase over Prior Year*	World Bank Tier 1 Membership Rate	World Bank Tier 2 Membership Rate	World Bank Tier 3 Membership Rate
7.5% or greater	$ 9.00	$ 10.00	$ 11.00
6% or greater	$ 7.00	$ 8.00	$ 9.00
4% or greater	$ 4.00	$ 5.00	$ 7.00
2% or greater	$ 3.00	$ 4.00	$ 6.00
0% or greater	$ 2.00	$ 3.00	$ 5.00
* Note: Industry Members only

Membership Revenue Share - Per Student Member
$2.00 per student member (as of roll taken on 31 December)

 

As part of the early research in this effort, we quickly learned that Affiliate/Chapter leaders wanted more formalized training in order to set them up for success with their new Affiliate/Chapter Board role.

In conjunction with the 2022 ISPE Annual Meeting being held in Orlando, FL, ISPE International will launch onboarding and training for the following Affiliate/Chapter Board roles: President/Chair, Vice-President/Co-Chair, Treasurer, and Secretary. This will initially be delivered in-person and then offered in an On-Demand format.

 

ISPE International is grateful for the ongoing efforts of the local Affiliate/Chapter in their efforts to support students worldwide. Based on Affiliate/Chapter leader feedback, we have included as part of the Membership Growth Incentives for each A/C to receive USD $2.00 for each student member from their Affiliate/Chapter, regardless of the student member count in the previous year.  

As part of the new Charter, and consistent with our vision of One ISPE, ISPE International will launch an Affiliate/Chapter Advisor Program to assist ISPE Chapters in various aspects of chapter development. ISPE Affiliate/Chapter Advisors are leaders within the ISPE community who have areas of expertise and are willing to share their knowledge with other Affiliates/Chapters. Affiliates/Chapter Advisors exemplify the values of ISPE and are aligned with the ISPE International Mission/Vision.

Advisors will share their experience and best practices with Affiliate/Chapters on topics ranging from Affiliate/Chapter management to delivering local education and training. Advisors will also help with local membership growth and retention best practices including promoting new and ongoing ISPE International programs, benefits, and initiatives that can assist with the future success of an ISPE Affiliate/Chapter.

 

We have listened and heard the various feedback on the current restrictions in the Affiliate/Chapter Charter and are pleased to share the modified restrictions below. For vendor nights or trade shows with more than 75 tables are subject to the following restrictions:

• For ISPE International Annual Meeting: Events with more than 75 exhibits may not be held within a radius of 400 miles /644 km, and 45 calendar days before and 30 calendar days after the ISPE event.
• For ISPE Europe Conference: Events with more than 75 exhibits may not be held within a radius of 125 miles/ 201 km, and 45 calendar days before and 30 calendar days after the ISPE event.
• All other ISPE International Conferences with an in-person component*: Events with more than 75 exhibits may not be held within a 125 miles/ 201 km radius, and 30 calendar days before and after the ISPE event.

*(i.e., any face-to-face or hybrid event presented by ISPE International with a duration exceeding one calendar day and includes attendees gathering at a physical location).

Please note: No Affiliate/Chapter event may exceed 375 tabletops at any time of the year. Included in this total is up to 10 supplemental displays which may include booths that do not exceed 10’ x 10’ per exhibitor or truck displays contained within a single trailer.

 

Please note that this is a requirement that is in the current ISPE Charter and is limited to program date(s) and location(s) for any of the larger events that the Affiliate/Chapter will be holding. This would include a significant event held by the Affiliate/Chapter including, but not limited to a trade show, product show, exposition, vendor night, conference, or symposium. ISPE will provide a template to the Affiliate/Chapter leaders available in the Affiliate/Chapter Resource page by the end of February 2022.  

That is true, under the new Charter there will be no topic restrictions for any event/programming at the local level.  

The new Charter contains a provision whereby ISPE will create and maintain a Charter Amendment Committee (CAC) to consider any proposed amendments to the ISPE Charter. The CAC will be comprised of a combination of four ISPE Members, two ISPE Board of Directors, and four ISPE Staff, totaling no more than 10 individuals.

The Process to Amend the ISPE Charter will be made available on the Affiliates-Chapters Resources page by the end of February 2022; to include information on the preliminary work, form completion, necessary signatures and form submission needed to amend the Charter.

It’s important that before submitting a form to change the Charter that you search all governing documents to gauge the effect of your proposed changes. Governing documents can be found on the Affiliates-Chapters Resources page.

Petition deadlines are thirty (30) calendar days before each Committee meeting; at least sixty (60) days are recommended for ISPE staff to have thirty (30) days to examine the amendment for legalities and financial impacts, return conclusions and allow for edits to the amendment before official submission. The annual CAC committee meeting schedule will be sent to Affiliate/Chapter leaders and posted on the Affiliates-Chapters Resources page.

Each Charter Amendment Request form must include the signatures of a minimum six (6) ISPE Affiliate/Chapter Leaders and the Chairs of the three regional Affiliate/Chapter Councils: North America/South America, Europe, and Asia Pacific.

 

ISPE has formalized the process for Affiliates/Chapters to request a waiver in an effort to remove any ambiguity to the process. The Affiliate/Chapter would submit a written request with the specific Charter requirements and justification to acrelations@ispe.org. ISPE International may request additional information from the Affiliate/Chapter and will allow a reasonable amount of time for Affiliate/Chapter to furnish such information. The Affiliate/Chapter will receive a final decision from ISPE International within 45 calendar days of receiving the request or additional requested information, whichever is later. If a waiver is granted, ISPE International will include the dates for which the waiver is applicable and any commitments that must be satisfied for the waiver. Waivers may be granted only on a one-time basis based on specific circumstances and isolated to the dates and conditions granted in the final waiver agreement.  

Maintaining positive relationships with global regulatory health authorities is an important aspect of ISPE’s success. In order to maintain positive relationships, communications with regulators need to follow any protocol that agencies and ISPE International have in place for requesting speakers. It’s important for your Affiliate/Chapter to follow the ISPE International’s Health Authority Interaction Policy..

All requests for speakers from the following agencies shall be made via ISPE International:

• European Commission (EC), European Medicines Agency (EMA) and 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)

To request a speaker from one of these agencies, the Affiliate/Chapter shall complete a Regulatory Speaker Request form, which can be found on the Affiliate/Chapter Resources page and submit it to regulatory@ispe.org. Affiliates/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 geographic region, the Affiliate/Chapter shall 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/Chapter located in the geographic region of the agency being requested.

Per the policies established by various agencies, requests for speakers must be submitted at least six (6) months before the event.

 

ISPE supports development and operation of local CoPs. We understand that local CoPs are formed when there is a need to address issues and represent local interests in specific countries or language-based geographic regions. They must be developed under the auspices of the Affiliate/Chapter Board of Directors as the Affiliate/Chapter is responsible for all local CoP activities and content. There must also be a direct relationship with the applicable global ISPE CoP.

Local CoPs are not directly supported by ISPE and there are no online communities established for local CoPs; however, ISPE staff can assist in the setup of local CoPs. Affiliate/Chapters interested in setting up a local CoP should contact CoP staff at communities@ispe.org. Anytime an Affiliate/Chapter forms a new local CoP, we ask that you inform CoP staff at communities@ispe.org.

 

Success indicators would include but not be limited to the following:

• Worldwide membership growth
• Active utilization of the Affiliate/Chapter Growth Fund
• Affiliate/Chapter utilization of the Roadmap to Success Checklist to gain benefits contained in the new Charter
• Affiliate/Chapter engagement with the ISPE International Board Liaison
• Financial stability of all Affiliates/Chapters
• Stronger partnerships and relationships between the Affiliate/Chapter and ISPE International

With your much needed support for the principles contained in the new Charter, we can further extend and connect pharmaceutical knowledge around the globe. As ISPE members, we can continue to reimagine a better world as we together shape the future of the pharmaceutical industry as One ISPE.