Independent Medical Education Overview for

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Independent Medical Education
Overview for U.S. Organizations
Shire Pharmaceuticals-SP
Updated: Q1 2014
Our purpose
We enable people with life-altering conditions to lead better lives.
Independent Medical Education Overview
• Therapeutic Areas of Interest (Slides 3-5)
• Funding Availability (Slide 6)
• Independent Medical Education (Slide 7)
• Continuing Medical Education
• Fellowship Funding
• Travel Grants for HCPs in Training
• Shire’s Expectations (Slides 8-10)
• Registration Eligibility, Registration and Submission Process (Slides 11-12)
• Financial Reconciliations (Slide 13)
• Reminders (Slide 14)
• Contact Information (Slide 15)
If you represent an organization outside of the United States, then please send an e-mail to ShireSupportCME@shire.com for further instruction.
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2
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.
If you are considering submitting an educational grant request in a therapeutic area not listed
then please e-mail ShireSupportCME@shire.com before submission.
To be as brave as the people we help.
3
Therapeutic Areas of Interest
• Binge Eating Disorder
• 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
• Ulcerative Colitis
• 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 ulcerative colitis.
• Motility Disorders
• Motility disorders are characterized by abnormal fluctuations of the
gastrointestinal tract muscle contractions. 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 in
special populations with motility disorders.
If you are considering submitting an educational grant request in a therapeutic area not listed
then please e-mail ShireSupportCME@shire.com before submission.
To be as brave as the people we help.
4
2013 Funding Availability
Therapeutic Area
Independent Medical Education
(Continuing Medical Education, Fellowship Funding, and Travel Grants for
HCPs in Training)
Attention Deficit Hyperactivity Disorder
Available
Binge Eating Disorder
Available
Gastroenterology – Mild to Moderate
Ulcerative Colitis
Available
Gastroenterology – Motility Disorders
Available
If you are considering submitting an educational grant request in a therapeutic area not listed
then please e-mail ShireSupportCME@shire.com before submission.
To be as brave as the people we help.
5
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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6
Shire’s Expectations Regarding Request Submissions
Request Submissions must be:
Additional Considerations:
•
•
•
•
Aligned with Shire’s areas of
therapeutic interest and developed
independently of Shire personnel
involvement.
Developed to address the
educational gap identified through
the needs assessment. The
educational gap could be related
to clinical practice, knowledge, or
skills.
Intended to meet the identified
educational gap, be appropriate
for the educational audience, and
lead to improved patient
outcomes.
•
•
•
•
Honoraria offered to healthcare
professionals serving as faculty
reflects fair market values.
Live educational activities must 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.
Educational activities will be
implemented in accordance with
Shire’s Letter of Agreement.
Organizations determined to be
non-compliant will be precluded
from requesting educational grant
funding from Shire.
To be as brave as the people we help.
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Shire’s Expectations Regarding Request Types
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




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
To be as brave as the people we help.
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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
To be as brave as the people we help.
9
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
x Individuals
x Private or group medical
practice(s)
x An organization that has been
debarred or is on the OIG
exclusion list
x An organization that is partially
or wholly owned by practicing
healthcare professionals
Notice to all requestors located in Massachusetts: Under Massachusetts 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 may have information on
this website relating to travel grants to independent scientific or medical congresses or meetings, 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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Registration and Submission Process
1. 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
2. Step Two
• Select the request type
• Medical Education Grants
3. Step Three
• Submit the request with attachments as applicable
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Financial Reconciliations
•
•
To be completed online at www.ShireSupport.com within 90 days of the activity date
Information Required:
•
•
Program Attendance
Final Budget reconciliation: comparative budget to actual reconciliation (Actual expenses for
the entire initiative; not just what Shire provided)
•
•
•
•
•
•
The evaluation summary
An outcomes report related to the questions posed in the application
A description of how the maintenance of certification areas were met
Documentation of the commercial support acknowledgement statement, i.e. “This activity was
supported by an independent medical educational grant from Shire.”
Refunds are required only if the reconciled budget balance is greater than $250
•
•
•
Total Funding received from all sources = all registration income, all educational grants, and funding
provided by the hosting organization
Refunds are due within 90 days of the financial reconciliation submission
Refund checks should be made payable to Shire and mailed to: 735 Chesterbrook Blvd,
Wayne, PA 19087 Attn: Joe Kerkering
Failure to reconcile educational grants may prevent future funding to your organization.
To be as brave as the people we help.
12
A Few Reminders
•
Independent Medical Education
funding requests must be:
•
•
•
In compliance with all applicable
guidelines
Aligned with Shire’s therapeutic areas
of interest
Submitted online at
(www.ShireSupport.com) without
assistance from Shire employees
•
•
Requests that are faxed, mailed, or emailed will not be reviewed
•
•
•
Requests may not include additional
funding support, i.e. sponsorship
requests
Submission, or past approvals, does
not guarantee support
Declined requests may not be
resubmitted
•
Exception: If a request is inadvertently
submitted in the wrong category,
ShireSupport personnel will provide
appropriate direction
Requests must be submitted at least
60 days in advance of the start date
•
•
Requests will not be reviewed if the
activity has begun or has taken place
Decisions are communicated by e-mail
within 45-60 days of the submission
date
Questions? ShireSupportCME@shire.com
To be as brave as the people we help.
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Contact Information
Shire
E-mail: ShireSupportCME@shire.com
Phone: 484-595-8253
Funding site: www.ShireSupport.com
Areas of Interest: ADHD, Binge Eating Disorder, Mild to Moderate
Ulcerative Colitis, Motility/Chronic Constipation
E-mail: ShireHGTsupport@shire.com
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.
14
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