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Our purpose We enable people with life-altering conditions to lead better lives. A Guide to www.ShireSupport.com Updated: Winter 2013 Shire Pharmaceuticals-SP.

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Presentation on theme: "Our purpose We enable people with life-altering conditions to lead better lives. A Guide to www.ShireSupport.com Updated: Winter 2013 Shire Pharmaceuticals-SP."— Presentation transcript:

1 Our purpose We enable people with life-altering conditions to lead better lives. A Guide to Updated: Winter 2013 Shire Pharmaceuticals-SP

2 To be as brave as the people we help. 2 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 Disclaimer: Massachusetts Finances Reminders Contact Information

3 To be as brave as the people we help. 3 Registration and Submission Process Step One Become a registered user of 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

4 To be as brave as the people we help. 4 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

5 To be as brave as the people we help. 5 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.

6 To be as brave as the people we help. 6 Therapeutic Areas of Interest Gastroenterology 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. 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.

7 Our purpose We enable people with life-altering conditions to lead better lives. Charitable Contributions Sponsorship Requests

8 To be as brave as the people we help. 8 Definitions of Funding Types Funding Request TypeDefinitionTherapeutic Areas Charitable Contributions Examples include: Fundraising events General support of patient advocacy organizations 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 All charitable giving must serve a clearly defined legitimate charitable purpose, and Shire may only receive an incidental benefit from any such contributions 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 Shire Pharmaceuticals-SP Gastroenterology specific to mild to moderate ulcerative colitis Hyperphosphatemia (Renal) Pediatric attention deficit hyperactivity disorder Adult attention deficit hyperactivity disorder 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.

9 To be as brave as the people we help. 9 Definitions of Funding Types Funding Request TypeDefinitionTherapeutic Areas Sponsorship Requests 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 Support for healthcare-related events or activities where Shire may receive a material commercial benefit in exchange for its contribution Sponsorships may be payable to organizations including hospitals, medical societies, medical schools, 501(c)(3)(4)(6) organizations, etc. Shire does not fund sponsorships payable to individual healthcare providers or medical practices. Shire Pharmaceuticals-SP Gastroenterology specific to mild to moderate ulcerative colitis Hyperphosphatemia (Renal) Pediatric attention deficit hyperactivity disorder Adult attention deficit hyperactivity disorder

10 Our purpose We enable people with life-altering conditions to lead better lives. Independent Medical Education Continuing Medical Education Fellowship Funding Requests Travel Grants for HCPs in Training

11 To be as brave as the people we help. 11 Independent Medical Education Funding Request TypeDefinition Continuing Medical Education“CME consists of educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public or the profession. The content of CME is the body of knowledge and skills generally recognized and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine and the provision of health care to the public.” Physician’s Recognition Award: Requirements for Accredited Providers assn.org/resources/doc/cme/pra-booklet.pdfhttp://www.ama- assn.org/resources/doc/cme/pra-booklet.pdf Funding Request TypeDefinition Fellowship Funding Shire may provide funding for post-graduate, medical training (fellowship funding) for healthcare professionals (HCPs) participating in a medical training program that is aligned with Shire’s therapeutic areas of interests at an accredited organization Funding Request TypeDefinition 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 interest

12 To be as brave as the people we help. 12 Shire’s Expectations: Independent Medical Education Aligned with Shire’s areas of interest and are 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. Intent is 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 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. 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.

13 To be as brave as the people we help. 13 Shire’s Expectations: Independent Medical Education Educational interventions for healthcare professionals include, but are not limited to: Courses: Local, Regional, or National Fellowship Funding Affiliated with an accredited organization Internet CME: Live or Archived Journal CME Performance Improvement Initiatives Teleconferences Travel Grants for HCPs in Training Must be associated with a major scientific meetings Examples of requests that Shire will not consider: Activities developed for professional or 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

14 Our purpose We enable people with life-altering conditions to lead better lives. Disclaimer Massachusetts Based Organizations

15 To be as brave as the people we help. 15 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.

16 Our purpose We enable people with life-altering conditions to lead better lives. Finances Funding Availability Ineligible Budget Items Reconciliations

17 To be as brave as the people we help. 17 Shire Pharmaceuticals-SP – 2013 Funding Availability Therapeutic AreaIndependent Medical Education (Continuing Medical Education, Fellowship Funding, and Travel Grants for HCPs in Training) Healthcare Related Charitable Contributions and/or Sponsorship Requests Adolescent and Adult Attention Deficit Hyperactivity Disorder Available Gastroenterology – Mild to Moderate Ulcerative Colitis Available Gastroenterology – Motility/Chronic Constipation Available Hyperphosphatemia (Renal)LimitedNot Available Pediatric Attention Deficit Hyperactivity Disorder Available

18 To be as brave as the people we help. 18 Shire’s Expectations: Ineligible Budget Items Independent medical education budget line items must not include: Prizes Gifts or service awards Funding for guests Travel and/or lodging reimbursement out of proportion with the activity dates Faculty dinners not aligned with content review Operating expenses not specifically aligned with the educational activity Expenses related to exhibits

19 To be as brave as the people we help. 19 Financial Reconciliation of Sponsorships All sponsorships must be reconciled within 90 days of the activity date Reconciliations are to be completed online at 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.

20 To be as brave as the people we help. 20 Financial Reconciliation for Independent Medical Education Reconciliations are due within 90 days of the activity date Reconciliations are to be completed online at 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.

21 To be as brave as the people we help. 21 Some Reminders… Funding requests must be aligned to a Shire Pharmaceuticals-SP therapeutic area of interest to be considered Funding requests must be submitted online to by the requesting organization without assistance from Shire employees Faxed, mailed, or ed requests will not be reviewed Funding requests must be in compliance with all applicable guidelines Timelines All requests – educational, charitable contributions, or sponsorships – must be submitted 60 days in advance Decisions are communicated by within 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 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? or

22 To be as brave as the people we help. 22 Contact Information Shire Pharmaceuticals-SP or Phone: Funding site: Areas of Interest: ADHD, Mild to Moderate Ulcerative Colitis, and Motility/Chronic Constipation Shire HGT Phone: Funding Site: Areas of Interest: Fabry Disease, Gaucher Disease Hereditary Angioedema (HAE), Hunter Syndrome, Metachromatic Leukodystrophy (MLD), and Sanfilippo Syndrome Shire Regenerative Medicine Phone: Areas of Interest: Diabetic foot ulcers, Complications associated with diabetes (e.g. renal impairment, peripheral neuropathy), Wound care and Dermal repair


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