Podcast
Questions and Answers
What is the main purpose of the policy?
What is the main purpose of the policy?
- To allow personal volunteering by employees.
- To ensure Agios supports legitimate organizations appropriately. (correct)
- To provide funding to any organization that requests it.
- To mandate research funding for all types of projects.
The policy applies to all personal volunteering by Agios employees.
The policy applies to all personal volunteering by Agios employees.
False (B)
Who can employees contact for questions about compliance with this policy?
Who can employees contact for questions about compliance with this policy?
A member of the Compliance team.
The policy does not apply to requests for research with third parties for __________ research.
The policy does not apply to requests for research with third parties for __________ research.
Match the types of support with their descriptions:
Match the types of support with their descriptions:
Who should be consulted to ensure compliance with Agios policies?
Who should be consulted to ensure compliance with Agios policies?
Agios allows retaliation against employees who report violations of the Code of Business Conduct and Ethics.
Agios allows retaliation against employees who report violations of the Code of Business Conduct and Ethics.
What are Compliance Handbooks intended to establish?
What are Compliance Handbooks intended to establish?
If there is a conflict between Agios policies, a Compliance Handbook, or an applicable law, employees must comply with the __________ standard.
If there is a conflict between Agios policies, a Compliance Handbook, or an applicable law, employees must comply with the __________ standard.
Match the following terms with their correct descriptions:
Match the following terms with their correct descriptions:
What type of payments are prohibited when Agios provides funding to external organizations?
What type of payments are prohibited when Agios provides funding to external organizations?
Agios can provide guidance to organizations receiving educational grants.
Agios can provide guidance to organizations receiving educational grants.
What is the primary purpose of the educational grants provided by Agios?
What is the primary purpose of the educational grants provided by Agios?
Agios may limit its funding of educational grants to topics of _____________ to Agios.
Agios may limit its funding of educational grants to topics of _____________ to Agios.
Match the following fund types with their descriptions:
Match the following fund types with their descriptions:
Which of the following statements is true regarding the audience for Agios-funded educational activities?
Which of the following statements is true regarding the audience for Agios-funded educational activities?
Agios can provide funds directly to individuals for educational purposes.
Agios can provide funds directly to individuals for educational purposes.
What ensures that the information presented in educational grants is accurate and balanced?
What ensures that the information presented in educational grants is accurate and balanced?
Who should receive Fellowship funding according to the policy?
Who should receive Fellowship funding according to the policy?
Agios may exert control over the content of an educational program funded by a Fellowship.
Agios may exert control over the content of an educational program funded by a Fellowship.
What type of studies may Agios support through Investigator-Sponsored Trials (ISTs)?
What type of studies may Agios support through Investigator-Sponsored Trials (ISTs)?
Funding for research activities cannot be used to cover a __________ for a position that bills services.
Funding for research activities cannot be used to cover a __________ for a position that bills services.
What must the investigator or sponsor maintain in Investigator-Sponsored Trials?
What must the investigator or sponsor maintain in Investigator-Sponsored Trials?
What is the main goal of providing support for Investigator-Sponsored Trials?
What is the main goal of providing support for Investigator-Sponsored Trials?
Flashcards
Agios Policy Applicability
Agios Policy Applicability
This policy applies to all Agios employees globally and must be read in conjunction with local Compliance Handbooks.
Policy Conflicts
Policy Conflicts
If a global policy, Compliance Handbook, or local law conflicts, the strictest standard must be followed.
External Organization Support
External Organization Support
When Agios provides funding or in-kind support to external organizations, local laws and regulations must be followed.
Purpose of Agios Funding Policy
Purpose of Agios Funding Policy
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Employee Training
Employee Training
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Compliance Team Consultation
Compliance Team Consultation
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Agios Funding Policy Applicability
Agios Funding Policy Applicability
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Reporting Policy Violations
Reporting Policy Violations
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Contact for Policy Questions
Contact for Policy Questions
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Third-Party Agreements
Third-Party Agreements
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Educational Grants
Educational Grants
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Independent Educational Activities
Independent Educational Activities
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Continuing Medical Education (CME)
Continuing Medical Education (CME)
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Balanced Information
Balanced Information
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No cash payments
No cash payments
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Funding Restrictions
Funding Restrictions
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Public Health Benefit
Public Health Benefit
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Appropriate Audience
Appropriate Audience
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What is an IST?
What is an IST?
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Agios's Support for ISTs
Agios's Support for ISTs
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Who Controls an IST?
Who Controls an IST?
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What are Acceptable Uses for IST Funding?
What are Acceptable Uses for IST Funding?
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How is Agios Funding Provided?
How is Agios Funding Provided?
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What's the Key Requirement for IST Funding?
What's the Key Requirement for IST Funding?
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ISTs and Agios: What is prohibited?
ISTs and Agios: What is prohibited?
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Study Notes
Funding and In-Kind Support of External Organizations
- Agios policy sets principles and minimum standards for funding and in-kind support to organizations.
- Policy applies to funding educational grants, investigator-sponsored trials (ISTs), donations, and sponsorships.
- Policy does not apply to research with third parties, compassionate use, or employee volunteering.
- Policy applies to all Agios employees globally.
- Employees must follow policy and applicable compliance handbooks.
- Contractors and third parties must comply with the policy and a written agreement.
- Questions about this policy may be directed to the compliance team.
- Any suspected policy violation should be reported to a manager, HR, compliance, or legal.
- Reports can also be made anonymously via the compliance helpline.
- Agios prohibits retaliation against those reporting violations in good faith.
- Agios employees will undergo regular training to cover the funding policies and procedures.
- Funds must be requested in writing with sufficient documentation.
- All external funding must be documented in a written agreement or acknowledgement.
- Funds must not be allocated for meals, recreation, or entertainment of HCPs in general.
- External funding should not be directed specifically at HCPs unless permissible by local laws.
General Requirements
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Agios may fund or provide in-kind support to organizations to further public health and enhance patient care.
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No funding or support may be provided to induce or reward prescriptions or recommendations.
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No funding may be used for inappropriate promotion.
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Funding is restricted to qualified organizations for legitimate purposes.
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Agios may not provide funding to individual healthcare providers (HCPs).
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Payments to recipients are restricted to qualified organizations.
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No cash payments.
Investigator-Sponsored Trials (ISTs)
- Support for ISTs is for legitimate scientific value.
- Support is for approved therapeutic and scientific areas.
- Support is not for new research that lacks a protocol.
- Product support may not be tied to funding.
Donations
- Agios can donate to non-profit organizations for charitable purposes.
- Donations must be justified and appropriate.
- Donations may not be given to individuals, physician groups, management companies or to organizations involved in recent Agios marketing activities.
- Donations should not provide a tangible benefit to Agios.
Continuing Medical Education
- Agios supports CME that improves patient care.
- Educational grant support is not for promoting specific Agios products.
Third-Party Educational Meetings & Other Educational Activities
- Agios may support third-party education activities that are scientifically and ethically sound.
Promotional Activities
- Agios may not participate in promotional activities concurrently with CME.
- Promotions should comply with standards and local laws.
Requests from Individual HCPs
- Donations to charities on behalf of individual HCPs are prohibited.
- Donations to charity patient assistance programs are allowed when appropriate.
Sponsorships
- Sponsorships must have a legitimate business reason; they must provide a tangible benefit.
- Sponsorship events must be broadly presented to other entities, not tailored specifically to Agios.
Studying That Suits You
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Description
Test your knowledge of the Agios policy on funding and in-kind support for external organizations. This quiz covers the principles, standards, and compliance requirements that all Agios employees must follow. Ensure you understand the key aspects of donations, sponsorships, and reporting violations.
