Independent Medical Education Overview for U.S. Organizations

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Independent Medical Education Overview for U.S. Organizations

Shire Pharmaceuticals-SP

Updated: Q1 2014

To be as brave as the people we help.

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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 [email protected] for further instruction.


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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.

If you are considering submitting an educational grant request in a therapeutic area not listed then please e-mail [email protected] before submission.


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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.



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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



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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.


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


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 Regarding Request Submissions

Request Submissions must be:

• 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.

Additional Considerations:

• 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.


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Shire’s Expectations Regarding Request Types

Educational requests that Shire WILLconsider include: Live Courses: Local, Regional, or

National Fellowship Funding

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

Educational requests that Shire WILL NOT consider:

x Activities developed for medical staff development

x Activities intended to develop clinical guidelines or algorithms

x Activities focused on promoting Shire products

x Activities that include retroactive support

x Activities developed by or in partnership with an organization that is partially or wholly owned by practicing healthcare professionals

x Activities designed for the location rather than education


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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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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.


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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)

• Total Funding received from all sources = all registration income, all educational grants, and funding provided by the hosting organization

• 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• 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.


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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 e-

mailed will not be reviewed

• 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

• 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

Questions? [email protected]


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Contact Information

Shire E-mail: [email protected]

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: [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

Documents

Independent Medical Education Overview for U.S. Organizations