Transcript A Guide to ShireSupport.com

A Guide to
www.ShireSupport.com
Updated: Winter 2014
Shire Pharmaceuticals-SP
Our purpose
We enable people with life-altering conditions to lead better lives.
www.ShireSupport.com
• These slides provide an orientation on
• Registration, Eligibility and Submission Process
• Therapeutic Areas of Interest
• Funding Types
• Charitable Contributions
• Sponsorship Requests
• Independent Medical Education
• Continuing Medical Education
• Fellowship Funding
• Travel Grants for HCPs in Training
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•
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Disclaimer: Massachusetts
Finances
Reminders
Contact Information
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Registration and Submission Process
• Step One
• Become a registered user of www.ShireSupport.com
• When registering please have the following materials available
• Legal name of the organization as registered with the IRS
• A signed PDF copy of the organization’s W9 form
• Note: Electronic signatures are NOT acceptable
• If applicable, a PDF copy of the organization’s non-profit
determination letter from the IRS
• Step Two
• Select the request type
• Medical Education Grants
• Healthcare related Charitable Contributions and/or Sponsorship
Requests
• Step Three
• Submit the request with attachments as applicable
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Registration Eligibility
• Eligible
• Medical Schools
• Hospitals/Medical Centers
• Medical Associations/Medical
Societies
• Patient Advocacy
Organizations
• Medical Education Companies
• Not for Profit organizations
•
501(c)(3)(4)(6)
• Ineligible
• Individuals
• Private or group medical
practice(s)
• An organization that has been
debarred or is on the OIG
exclusion list
• An organization that is partially
or wholly owned by practicing
healthcare professionals
If you represent an organization located in Massachusetts, please refer to slides 14-15.
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Therapeutic Areas of Interest
• ADHD
• Adult
• ADHD is a chronic neurologically based disease. Therefore Shire’s
educational goal is to fund education that provides specialists with the
information and tools needed to improve the screening, diagnosis,
treatment, and management of adult patients with ADHD.
• Adolescents
• ADHD is a chronic neurologically based disease. Therefore Shire’s
educational goal is to fund education that provides specialists with the
information and tools needed to improve the screening, diagnosis,
treatment, and management of adolescent patients with ADHD.
• Pediatric
• ADHD is a chronic neurologically based disease. Therefore Shire’s
educational goal is to improve the screening, diagnosis, treatment, and
management of pediatric patients with ADHD.
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Therapeutic Areas of Interest
•
Binge Eating Disorder
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•
Binge eating disorder is characterized by compulsive overeating. Shire’s
educational goal is to fund education that provides specialists with the
information and tools needed to improve the diagnosis and treatment of adult
patients with binge eating disorder.
Gastroenterology
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Mild to Moderate Ulcerative Colitis
• Mild to moderate ulcerative colitis is a disease characterized by inflammation
and ulceration of the lining of the colon and rectum. Shire’s educational goal
is to fund education that provides specialists with the information and tools
needed to improve the screening, diagnosis, treatment, and management of
patients with mild to moderate ulcerative colitis.
Motility/Chronic Constipation
• Chronic constipation is characterized by infrequent and difficult passage of
stools over a prolonged period and a range of bothersome symptoms.
Shire’s educational goal is to fund education that provides specialists with
the information and tools needed to improve the screening, diagnosis,
treatment, and management of female patients with chronic constipation.
To be as brave as the people we help.
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Therapeutic Areas of Interest
• Renal
• Hyperphosphatemia
• Hyperphosphatemia is an abnormal concentration of phosphates in the
blood. Shire’s educational goal is to fund education that provides specialists
with the information and tools needed to improve the screening, diagnosis,
treatment, and management of patients with hyperphosphatemia.
To be as brave as the people we help.
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Charitable Contributions
Sponsorship Requests
Our purpose
We enable people with life-altering conditions to lead better lives.
Definitions of Funding Types
Funding Request Type
Definition
Therapeutic Areas
Charitable Contributions
Donations to support the general activities of
a registered tax-exempt organization under
sections 501(c)(3)(4)(6) of the Internal
Revenue Code, which are engaged in
healthcare-related charitable purposes
Shire Pharmaceuticals-SP
Examples include:
Fundraising events
General support of patient advocacy
organizations
All charitable giving must serve a clearly
defined legitimate charitable purpose, and
Shire may only receive an incidental benefit
from any such contributions
• Gastroenterology specific to mild to
moderate ulcerative colitis
•Hyperphosphatemia (Renal)
• Pediatric attention deficit hyperactivity
disorder
• Adult attention deficit hyperactivity disorder
www.ShireSupport.com
Charitable contributions may be payable to
organizations including hospitals, medical
societies, medical schools, 501(c)(3)(4)(6)
organizations, etc.
Use of charitable contribution funds is
unrestricted, which means Shire does not
control the recipient’s use of the funds; use is
at the sole discretion of the recipient
Notice to all requestors located in Massachusetts: due to the Massachusetts Pharmaceutical and Device Manufacturer Conduct Law, Shire is unable to fund
requests for the financial support for the costs of travel, lodging, or other personal expenses of non-faculty health care practitioners attending any CME
event, third-party scientific or educational conference, or professional meetings, either directly to the individuals participating in the event or indirectly to the
event’s sponsor. While Shire has information on the charitable section of this website relating to Fellows and Residents travel grants, any organizations
located in Massachusetts are not eligible due to this law.
To be as brave as the people we help.
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Definitions of Funding Types
Funding Request Type
Definition
Therapeutic Areas
Sponsorship Requests
Support for healthcare-related events or
activities where Shire may receive a material
commercial benefit in exchange for its
contribution
Shire Pharmaceuticals-SP
Examples include:
Payments to become a tier (e.g., gold,
platinum, etc.) sponsor at a medical society’s
or patient advocacy group’s annual meeting
Payment for exhibit space at a medical
conference or seminar
Patient Education
Sponsorships may be payable to
organizations including hospitals, medical
societies, medical schools, 501(c)(3)(4)(6)
organizations, etc.
• Gastroenterology specific to mild to
moderate ulcerative colitis
•Hyperphosphatemia (Renal)
• Pediatric attention deficit hyperactivity
disorder
• Adult attention deficit hyperactivity disorder
www.ShireSupport.com
Shire does not fund sponsorships payable to
individual healthcare providers or medical
practices.
To be as brave as the people we help.
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Independent Medical Education
Continuing Medical Education
Fellowship Funding Requests
Travel Grants for HCPs in Training
Our purpose
We enable people with life-altering conditions to lead better lives.
Independent Medical Education
Funding Request Type
Definition
Continuing Medical Education
Shire may provide funding for continuing medical education initiatives
that are aligned with Shire’s therapeutic areas of interest and are
designed for healthcare professionals. All decisions related to the
development and implementation of the educational initiative belong to
the provider. Shire has no role in continuing medical education initiatives.
Funding Request Type
Definition
Fellowship Funding
Shire may provide funding for post-graduate, medical training (fellowship
funding) for healthcare professionals (HCPs) participating in a medical
training program at an accredited organization that is aligned with Shire’s
therapeutic areas of interests
Funding Request Type
Definition
Travel Grants for HCPs in Training
Shire may provide modest travel grants to fellows, residents, medical
students, and other HCPs in training for attendance at major scientific
meetings aligned with Shire’s areas of therapeutic interest
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Shire’s Expectations: Independent Medical Education
•
Aligned with Shire’s areas of interest and are developed independently of Shire personnel
involvement.
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Developed to address the educational gap identified through the needs assessment. The
educational gap could be related to clinical practice, knowledge, or skills.
•
Intent is to meet the identified educational gap, be appropriate for the educational audience, and
lead to improved patient outcomes.
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Honoraria offered to healthcare professionals serving as faculty reflects fair market values.
•
Live educational activities will be held at modest locations, which provide an environment
conducive to learning.
•
Modest meals or social events will not compete with or take precedence over the educational
activity.
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Educational activities will be implemented in accordance with Shire’s Letter of Agreement.
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Organizations determined to be non-compliant will be precluded from requesting educational grant
funding from Shire.
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Shire’s Expectations: Independent Medical Education
Educational requests that Shire WILL
consider include:
Educational requests that Shire WILL NOT
consider:
 Live Courses: Local, Regional, or
National
 Fellowship Funding
x
 Affiliated with an accredited
organization
 Enduring materials
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
Internet: Live or Archived
Journal
Print
Multimedia
 Performance Improvement CME
 Teleconferences
 Travel Grants for HCPs in Training
 Must be associated with a major
scientific meeting
x
x
x
x
x
Activities developed for medical staff
development
Activities intended to develop clinical
guidelines or algorithms
Activities focused on promoting Shire
products
Activities that include retroactive
support
Activities developed by or in
partnership with an organization that is
partially or wholly owned by practicing
healthcare professionals
Activities designed for the location
rather than education
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Disclaimer
Massachusetts Based
Organizations
Our purpose
We enable people with life-altering conditions to lead better lives.
Massachusetts Pharmaceutical and Device Manufacturer Conduct
Law
• Shire is unable to fund requests for the financial support
for the costs of travel, lodging, or other personal
expenses of non-faculty health care practitioners
attending any CME event, third-party scientific or
educational conferences, or professional meetings,
either directly to the individuals participating in the event
or indirectly to the event’s sponsor.
• While Shire has information on the Continuing Medical
Education section of this website relating to Fellowship
Funding and Travel Grants for HCPs in Training,
organizations located in Massachusetts are not eligible
due to this law.
To be as brave as the people we help.
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Finances
Funding Availability
Ineligible Budget Items
Reconciliations
Our purpose
We enable people with life-altering conditions to lead better lives.
Shire Pharmaceuticals-SP – 2014 Funding Availability
Therapeutic Area
Independent Medical
Education
(Continuing Medical Education, Fellowship Funding,
and Travel Grants for HCPs in Training)
Healthcare Related Charitable
Contributions and/or
Sponsorship Requests
Attention Deficit Hyperactivity
Disorder
Available
Available
Binge Eating Disorder
Available
Available
Gastroenterology – Mild to
Moderate Ulcerative Colitis
Available
Available
Gastroenterology –
Motility/Chronic Constipation
Available
Available
Hyperphosphatemia (Renal)
Not Available
Not Available
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Shire’s Expectations: Ineligible Budget Items
• Independent medical education budget line items may not include:
x Prizes
x Gifts or service awards
x Funding for guests
x Travel and/or lodging reimbursement out of proportion with the activity
dates
x Faculty receptions or dinners not aligned with content review
x Operating expenses not specifically aligned with the educational activity
x Expenses related to exhibits or other sponsorship activities
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Financial Reconciliation of Sponsorships
• All sponsorships must be reconciled within 90 days of
the activity date
• Reconciliations are to be completed online at
www.ShireSupport.com
• What’s needed
• Comparative budget to actual reconciliation
• Program expenses for the entire initiative must be included (not just
funding provided by Shire)
• Documentation of the commercial support acknowledgement
statement
• Note that failure to reconcile this request may prevent
future Charitable and/or Sponsorship funding to your
organization.
To be as brave as the people we help.
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Financial Reconciliation for Independent Medical Education
• Reconciliations are due within 90 days of the activity date
• Reconciliations are to be completed online at
www.ShireSupport.com
• Complete the online reconciliation form with
• Attendance information
• Comparative budget to actual reconciliation (Program expenses for
the entire initiative; not just what Shire provided)
• Total Funding received from all sources = registration income,
educational grants, and funding provided by the hosting organization
• The evaluation summary
• Documentation of the commercial support acknowledgement
statement, i.e. “This activity was supported by an independent
medical educational grant from Shire.”
• Refunds are only due if the amount is greater than $250
• Failure to reconcile educational grants may prevent future
funding to your organization.
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Some Reminders…
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Funding requests must be aligned to a Shire Pharmaceuticals-SP therapeutic area of
interest to be considered
Funding requests must be submitted online to www.ShireSupport.com by the
requesting organization without assistance from Shire employees
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Funding requests must be in compliance with all applicable guidelines
Timelines
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All requests – educational, charitable contributions, or sponsorships – must be submitted 60
days in advance
Decisions are communicated by e-mail within 45-60 days of the request date
Requests will not be reviewed or approved after the activity has begun or taken place
Submission, or past approvals, does not guarantee support
Declined requests cannot be resubmitted
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Faxed, mailed, or e-mailed requests will not be reviewed
If a request is inadvertently submitted in the wrong category ShireSupport personnel will
provide appropriate direction
Independent medical education requests may not include sponsorship requests and
vice versa
Questions?
• [email protected] or [email protected]
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Contact Information
Shire
PharmaceuticalsSP
Charitable and Sponsorships E-mail: [email protected]
Phone: 484-595-8253
Independent Medical Education Email: [email protected]
Phone: 484-595-2632
Funding site: www.ShireSupport.com
Areas of Interest: ADHD, Binge Eating Disorder, Mild to Moderate
Ulcerative Colitis, Motility/Chronic Constipation, and
Hyperphosphatemia
Shire HGT
E-mail: [email protected]
Phone: 617-613-4999
Funding Site: www.ShireHGTsupport.com
Areas of Interest: Fabry Disease, Gaucher Disease
Hereditary Angioedema (HAE), Hunter Syndrome,
Metachromatic Leukodystrophy (MLD), and Sanfilippo Syndrome
To be as brave as the people we help.
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