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Grantsmanship Webinar:
Overview of Genentech’s
Grant Request Process for Independent
Medical Education (IME) Support
December 2008
Meet Our Presenter
• Kristin Rand, JDGroup Product Manager
Independent Medical Education Department
Genentech, Inc.
2
3
Agenda
Genentech, Medical Education Support and IMED
What is the process for requesting independent
medical education grant funding from Genentech?
What tools and resources are available to providers?
Q & A
4
Participant Survey:
What Industry Segment Do You Represent?
1. Academic medical center
2. Community hospital
3. Specialty/medical association or society
4. Medical education company
5. Pharma/biotech industry
6. Other
5
Participant Survey:If you are an educational provider, how many educational
activities do you plan and implement on an annual basis?
1. 1-5
2. 5-10
3. 11-25
4. 26-50
5. More than 50
6
Participant Survey:Is this your first time participating in a Genentech webinar re:
independent medical education Grant Application Processes?
1. Yes
2. No
7
Agenda
Genentech, Medical Education Support and IMED
What is the process for requesting independent
medical education grant funding from Genentech?
What tools and resources are available to providers?
Q & A
8
Genentech’s Vision, Mission & Goals for
Independent Medical Education Support
GoalsGoals
MissionMission
VisionVision
Encourage and support the evolution of quality
independent medical education while ensuring alignment
with ACCME, AMA, PhRMA Code, OIG, and FDA
guidance.
Ensure that grant applications are received, handled,
reviewed, and evaluated according to the highest
standards and in full compliance with applicable laws,
regulations, and guidelines.
Genentech’s is committed to supporting quality
independent medical education that improves patient care.
Genentech’s Independent Medical Education Department (IMED) Genentech’s Independent Medical Education Department (IMED)
manages the review and approval of all IME grant activity manages the review and approval of all IME grant activity
9
Genentech’s Independence
Note: Genentech personnel outside of IMED may not in any way assist with or facilitate
grant requests during any phase of the request, nor can they forward grant requests to
IMED on behalf of a provider.
Genentech will Genentech will
NOT:NOT:
Influence the
development of
educational
content
Select educational Select educational
methods or venue
Influence selection Influence selection
of presenters
and/or moderators
Define educational
needs or objectives
Define educational
needs or objectives
for an activity
Influence selection
of persons who will
be in a position of
Influence selection
of persons who will
be in a position of
control over the
content
10
What’s New for Genentech’s IMED?
Funding availability information
Implementation updates and status reports on
approved grants
Now accepting educational outcomes in
reconciliations
Relaunching www.imed.gene.com website (new
content on processes, helpful tips)
11
Agenda
Genentech, Medical Education Support and IMED
What is the process for requesting independent
medical education grant funding from Genentech?
What tools and resources are available to providers?
Q & A
12
Independent Medical Education Grant
Process
1 2 3 4
Grant
ApplicationBefore You
Begin
IMED Application
Review
Implementation
Phase
Providers must
ensure that grant
requests meet
IMED criteria
New requestors
must first
register online
(accept
Genentech’s
Compliance
Commitment;
ensure firewall
compliance;
submit signed
IRS W9)
Grant requests
must be
submitted via
www.imed.gene.
com
Requests must
be submitted no
less than 60
calendar days
prior to the
planned activity
start date or the
date the
requestor
requires a
decision
(whichever is
earlier)
IMED will review
requests to
ensure that
activities are
compliant, fair-
balanced,
scientifically
rigorous, and
unbiased
The review
process can take
up to 60 calendar
days
IMED provides
limited optional
activity
assistance upon
request
IMED will request
monthly updates
during program
implementation
and may request
additional status
reports
5 6
Grant
Decision
Post-Activity
Reconciliation
IMED will
approve or deny
the grant request
Providers will be
notified of the
grant decision
via e-mail
IMED will require
reconciliation of
all funded
activities within
90 days of the
completion of
the activity
13
Independent Medical Education Grant
Process
1 2 3 4
Grant
ApplicationBefore You
Begin
IMED Application
Review
Implementation
Phase
5 6
Grant
Decision
Post Activity
Reconciliation
Grant Types
Charitable and Charitable and
Patient ProgramsPatient Programs
IMEDIMED
Research and Research and
DevelopmentDevelopment
Other SupportOther Support
Community and Charitable ActivitiesCommunity and Charitable Activities
Patient AdvocacyPatient Advocacy
Education (Education (Not for HCPs)Not for HCPs)
Medical Foundation SupportMedical Foundation Support
Note: must be 501c3 organizationsNote: must be 501c3 organizations
Independent Medical Education for healthcare professionals Independent Medical Education for healthcare professionals
Professional Society and Association Educational SupportProfessional Society and Association Educational Support
Live Educational ActivitiesLive Educational Activities
Print, Recorded, and Interactive, ComputerPrint, Recorded, and Interactive, Computer--Based ProgramsBased Programs
Travel Grants for Healthcare Professionals in Training Travel Grants for Healthcare Professionals in Training
Research and Development FellowshipsResearch and Development Fellowships
Other ThirdOther Third--Party Awards to FellowsParty Awards to Fellows
Institutional Grants to Fund ResearchInstitutional Grants to Fund Research
Medical AssociationMedical Association--Initiated FellowshipInitiated Fellowship
Trade Society/Association RequestsTrade Society/Association Requests
AdvertisingAdvertising
Promotional Exhibit/Display SpacePromotional Exhibit/Display Space
Genentech Supports Many Types Of Grants & SponsorshipsGenentech Supports Many Types Of Grants & Sponsorships
* Please refer to * Please refer to www.grants.gene.comwww.grants.gene.com for additional information.for additional information.
15
Eligible Providers
Firewall requirements
Accreditation
Eligible Audiences
HCPs in training
Therapeutic Areas of Interest
Educational Format
Ineligible Grant Requests
Grant Criteria
cc
dd
ee
bb
aa
16
Grant Criteria: Eligible Providersaa
Community HospitalsCommunity Hospitals
Professional Societies and Professional Societies and
AssociationsAssociations
Academic InstitutionsAcademic Institutions
Medical Education and Medical Education and
Communication CompaniesCommunication Companies
OtherOther
17
Grant Criteria: Eligible Providers Firewall Requirements
Genentech prohibits providers* and other educational partners from both
performing promotional activities and providing or accrediting independent
medical education, unless an adequate firewall is in place
The following firewall policy criteria must be satisfied by providers and their
educational partners** seeking funding from Genentech for an IME activity if the
provider has a parent or sister company conducting or potentially conducting
promotional or strategic activities for or on behalf of Genentech:
Separate employees/contractors
Separate legal entity
Separation of promotional/IME information and content
– Prohibition of sharing substantive information
– Physical separation of functions
– Information technology (IT) safeguards
Compliance training and audits
Monitoring of compliance policies
*Including parent or sister companies
**List is not all-inclusive. Please see www.imed.gene.com for complete list of criteria
aa
18
Grant Criteria: Eligible ProvidersAccreditation
Preference will be given to activities and initiatives that are
accredited for continuing healthcare professional education
(CME/CE)
CME/CE credit not required for approval
However, it is an expectation and requirement that activities
funded via IME grants be conceived, planned and executed
following conditions consistent with accredited activities.
If the grant request is for $15,000 or greater and the proposed
activity or initiative is accredited for continuing education, the
accredited provider must be the one requesting the grant
funding from Genentech and is responsible for the activity or
initiative
Payment can only be made to the grant requestor.
aa
19
Grant Criteria: Eligible Audiences*
Physicians Physicians
(Primarily specialist-
focused)
Nurses / Nurse PractitionersNurses / Nurse Practitioners
Pharmacists
Physician Assistants
bb
Medical Directors, Case Medical Directors, Case
Managers, Pharmacy
Directors Practice Managers
Other Allied HCPsHCPs in Training
(i.e., fellows and residents)
*Varies by therapeutic area
20
Grant Criteria: Eligible AudiencesEducation Grants for HCPs in Training
EligibilityEligibility
CriteriaCriteria
Funding may be permissible for HCPs in training (i.e., residents,
fellows, others), in accordance with criteria set forth below for:
Funding may be permissible for HCPs in training (i.e., residents,
fellows, others), in accordance with criteria set forth below for:
• Travel
• Lodging
• Other conference-related expenses
This is an exception to the general rule that there can be no
funding for attendee travel and lodging.
Activities must be held in conjunction with an established activity,
defined as the major educational, scientific, or policy making
meeting of a national, regional, or specialty medical association,
per the
for Gifts to Physicians From Industry
HCPs in training must be selected through a formal selection
process implemented by the academic or training institution
submitting the grant request.
This is an exception to the general rule that there can be no
funding for attendee travel and lodging.
Activities must be held in conjunction with an established activity,
defined as the major educational, scientific, or policy making
meeting of a national, regional, or specialty medical association,
per the American Medical Association (AMA) Ethical Guidelines
for Gifts to Physicians From Industry.
HCPs in training must be selected through a formal selection
process implemented by the academic or training institution
submitting the grant request.
bb
21
Grant Criteria: Therapeutic Areas of Interest
Allergic Disease
• Asthma
Oncology
Breast Cancer
Gastrointestinal Cancer
General Oncology
Glioma
Hematology
Non-Hodgkins Lymphoma
Ovarian Cancer
Prostate Cancer
Renal Cancer
Thoracic Cancer
Cardiovascular
Acute Myocardial Infarction
Dermatology
Psoriasis
Endocrinology
Adult Growth Hormone Deficiency
Disorders of Growth and
Development
Nephrology
• Lupus Nephritis
Neurology
Acute Ischemic Stroke
Multiple Sclerosis
Ophthalmology
Retinal Neovascular Disorders
Pulmonology
Cystic Fibrosis
Pulmonary Embolism
Rheumatology
Arthritis
Thrombolytic Therapy
Catheter Clearance
Immunology
• General Immunology
General
Access to Therapy
Education relevant to Payers,
Employers and Practice Managers
Educational effectiveness and
Practice Improvement
Priority is given to activities consistent with
Genentech’s therapeutic areas of interest**
cc
** Note: This list may change without notice. Please refer to www.imed.gene.com. ** Note: This list may change without notice. Please refer to www.imed.gene.com.
22
Grant Criteria: Educational Format
Eligible activity formats include:
dd
LiveLive
Society & Society &
Association Association
Educational SupportEducational Support
Enduring MaterialEnduring Material
Symposia/satellite Symposia/satellite
symposiasymposia
MultiMulti--speaker speaker
meetingsmeetings
Grand roundsGrand rounds
WebcastsWebcasts
TeleconferencesTeleconferences
Printed media Printed media
(monographs, (monographs,
newsletters)newsletters)
•• Interactive digital Interactive digital
media (Internet, media (Internet,
CDCD--ROMs)ROMs)
•• Recorded programs Recorded programs
(e.g. podcasts, (e.g. podcasts,
webcasts)webcasts)
Educational Educational
sessions at sessions at
annual meetingannual meeting
Not Not generalgeneral
support of the support of the
overall meetingoverall meeting
23
Grant Criteria: Ineligible Grant Requests
Grants to individuals or group practices
Retroactive support for activities previously initiated or completed,
including enduring materials
Enduring materials based on a previously-completed activity will not be considered
Travel, lodging, or registration expenses for non-faculty healthcare
professionals to attend an educational activity (some limited exceptions
for HCPs in training)
Capital or operating expenses
Stand-alone or significant entertainment or social activities
Staff/professional development
“Meals Only” grant requests
Requests for exhibits/displays
providers may indicate there is an opportunity for exhibits/displays, but such indication
not factored into grant review process)
Exhibits/displays can be offered to/paid by other Genentech departments (Sales)
Note: This is not an all-inclusive list. Please see www.imed.gene.com for additional information.
ee
24
Independent Medical Education Grant
Process
1 2 3 4
Grant
ApplicationBefore You
Begin
IMED Application
Review
Implementation
Phase
5 6
Grant
Decision
Post Activity
Reconciliation
25
To Get Started
The IMED website to help
providers apply for a grant, and includes:
The IMED website provides information and resources to help
providers apply for a grant, and includes:
Current therapeutic areas of interest
Eligibility criteria
Application process overview
Link to online application
FAQs, guidelines, and links to helpful resources
www.imed.gene.comwww.imed.gene.com
* Bookmark this page and check back often for updated information.
26
Applying for a Grant
• Online Application:
• Providers may only register and apply for a grant directly through www.imed.gene.com.
Providers should save username and password information for future grant applications
Registration must be renewed annually when notified by IMED
• Funding Availability:
• Providers can call IMED (866.599.4363) to inquire about available funding prior to applying online
• General indication of sufficient funding does not constitute commitment/assurance of grant support
27
Applying for a Grant (cont.)
Confirmation:
Once a grant request is submitted, a confirmation e-mail will be sent to the provider.
Users should check their e-mail and spam filters if confirmation is not received shortly after completing a submission
If confirmation is not received within 24 hrs, please contact IMED
Status:
The Grant Requestor Inbox will allow users to access and track their applications 24 hours a day, 7 days a week.
Note: The online system will not allow for submission of grants less than 60 days prior to the planned start date of the activity.
28
Compliance Commitment
―Compliance Commitment‖ – part of Genentech’s registration
process for all providers interested in applying for IME grant support
By accepting commitment, grant requestors agree to comply with
relevant guidelines, including, but not limited to: ACCME, ACPE,
CCRN, AAMC, ACCME, and PhRMA R
Regardless of whether an activity provides CME/CE credits
Other terms of the Compliance Commitment: Does not constitute or represent a funding commitment by Genentech for the specified
educational activity
If grant request is approved, Genentech’s actual provision to you of grant funds will constitute
its sole funding commitment for the educational activity
Indicates that neither the requestor nor the requestor’s organization is involved with any
Genentech promotional activities
Certifies that neither the requestor nor the requestor’s organization is on the OIG, FDA, or
ACCME debarment or exclusion lists
What We Look For
Needs assessment and Needs assessment and
learning objectiveslearning objectives
Appropriate activity Appropriate activity
format/instructional format/instructional
design for the intended design for the intended
target audiencetarget audience
Activity content aligned Activity content aligned
with needs assessment with needs assessment
and learning objectivesand learning objectives
Creative and interactive Creative and interactive
conceptsconcepts
FairFair--balancebalance
Scientific rigorScientific rigor
Provider expertise in Provider expertise in
relevant therapeutic arearelevant therapeutic area
Overall quality of activity Overall quality of activity
and implementation planand implementation plan
ComplianceCompliance
Grant requests are reviewed using the following criteria:
30
Grant Requestor and 3rd Parties
Grant Submission
Grants ≥ $15,000: If the activity is accredited the accredited provider must submit the grant request
Grants < $15,000: Grants may be submitted by a party other than the accredited provider
Grant applicant (and recipient) is fully accountable for all aspects of the grant and corresponding activities, regardless of roles and subordinate-assignments
Grant Notification and Letter of Agreement (LOA) Acceptance
If: the grant request is less than or equal to $15,000, the activity is accredited, and the requestor is not the accredited provider:
The accredited provider receives an email indicating that they have been named as the accredited provider
If the grant is approved, the accredited provider receives a second email indicating that the grant has been approved
The accredited provider will be required to register on the GMA system and agree to the terms of the LOA along with the grant requestor
If the user requires a copy of the LOA is, the LOA must be printed from the user’s web browser prior to selecting “Submit”
31
Required Information and Documentation
Grant requests require the following
documentation:
Signed IRS W9 form
Needs assessment (unmet educational need, performance
gaps)
Activity learning objectives
Proposed agenda and/or content outline
Budget details for entire activity
Implementation plan*
•For activities with total budget ≥ $15,000.
• This is not for the purpose of managing or directing the execution of an activity, but to provide assurance
that there is a plan to execute the activity consistent with the intention of the grant
** A sample grant request and additional resources are available once you register and login to the online
grant application.
32
Needs Assessment
• A needs assessment describes the specific educational need or
gap the activity is planning to address. Below are four examples
of objective sources that could be used to validate need.
Data Source SamplesData Source SamplesData Source SamplesData Source Samples ExamplesExamplesExamplesExamples
1. Expert Data
Literature searches of peer-reviewed medical literature
Practice guidelines and other published reports
Advisory Board feedback independent of Genentech
Practitioner/thought leader interactions
2. Market Research on
Professional Needs
Focus panels
Medical education feedback
Survey(s) of the proposed target audience
3. Observed Data
National and regional data from national research
institutes and healthcare organizations
Professional organizations (CDC, NIH, other)
Reviews of past, present, and future planned activities
4. Past Activity Evaluation
Summaries/Outcomes
Measurement
33
Learning Objectives and Agenda
Clearly state what participant will learn from the activity
Clarify to grant reviewers the purpose of the activity
Be consistent with the needs assessment
Clarify the content within the activity and their duration
Show time devoted to education vs. meals and entertainment,
if applicable
Be consistent with the learning objectives
Learning
Objectives
Must…
The Agenda/
Content Outline
Must…
1
2
3
1
2
3
All grant applications must include the activity’s learning objectives
along with a copy of the activity’s agenda and/or content outline.
34
Detailed Line-Item Budget
Activity Development and Management Activity Development and Management
Meeting Costs
Audience generation
Meals during educational activity (please specify number of meals and cost per person per meal)
Meeting room
Materials
Audio/visual support/equipment rental
Honoraria (select therapeutic area, specialty, role of recipient (faculty, moderator, etc), and indicate number of faculty
Travel (faculty and provider/staff only)
Indicate all travel-related expenses separately
Hotel/Lodging (faculty and provider/staff only)
Indicate number of hotel nights per faculty/staff member
Production Services
Print/production (please provide detailed cost breakdown)
Shipping
Web-delivery expenses
Accreditation
• Budget details for the total budget for the activity will be requested.
• Total amount and the amount requested from Genentech should be
entered in the grant application where indicated
35
Budget Template: Sample
Activity Summary provides a
highlight of the activity, including
activity type and cost
Grant Request Summary are populated
automatically from the completed
spreadsheet
The line item cost is populated by:
(unit cost) x (hours or units)
36
Uploading Documents within Online
Grant Application
• A Document Upload Page will allow providers to upload the grant
request’s supporting documents, as required and as indicated by a “*”
within the online application site
Upload process similar to uploading documents to an e-mail
Completed W-9 required for all requests
For grants for which entire program budget is $15,000 or greater, upload
requirements also include:
Detailed Needs Assessment
Implementation Plan
Sample Agenda
Sample Invitation (if relevant)
* For total activity budgets ≥ $15,000
37
Uploading Documents within Online Grant
Application: Document Upload Page
* For total activity budgets ≥ $15,000
** W-9s must be updated annually in your user profile.
38
Further Clarification:
Implementation Plans
Provide timeline and milestones
Explain how the activity will be executed
Provide the format for the activity (e.g., didactic, case-based, interactive)
Explain the educational method used, including the significance or uniqueness of
the approach
Explain how fair-balance will be ensured in activity content
Indicate the roles and qualifications for all of the educational partners, including the
accredited provider and any third parties
Explain how attendees will be encouraged to participate in the activity
Include specific examples of similar initiatives conducted in the past
Note: This is not for the purpose of managing or directing the execution of an
activity, but to provide assurance that there is a plan to execute the activity
consistent with the intentions of the grant. Further guidance available on website
and in application
* Providers must submit an implementation plan for grant activities with budgets that are
greater than or equal to $15,000
39
Application Checklist
Time Key Supporting Documents
The application checklist will help ensure complete applications are
submitted to Genentech.
Content Other
Request is submitted at least 60 days
prior to activity’s start date or the date a
decision is required
Duration of activity is appropriate to meet
learning objectives
Time allocated for learning is not over-
shadowed by time allocated for
meals/entertainment, if applicable
Needs assessment is well-developed,
current, and clearly identifies relevant
educational gaps and is fully
referenced
Learning objectives are clearly
defined, realistic, and aligned with the
needs assessment
Agenda and/or content outline is
consistent with learning objectives and
needs assessment
Activity is scientifically rigorous,
balanced, and unbiased
Request is in alignment with areas of
educational interest to Genentech
Proposed faculty is appropriate for the
content and educational objectives
Budget is reasonable, cost-effective, and in
line with fair market value
40
Independent Medical Education (IME)
Grant Process
1 2 3 4
Grant
ApplicationBefore You
Begin
IMED Application
Review
Implementation
Phase
5 6
Grant
Decision
Post Activity
Reconciliation
41
Decision and Letter of Agreement (LOA)
Timeline and Rationale
Wk 1Wk 1 Wk 2Wk 2 Wk 3Wk 3 Wk 4Wk 4 Wk 5Wk 5 Wk 6Wk 6 Wk 7Wk 7 Wk 8 Wk 9 Wk 10 Wk 11 Wk 12
Initial
Review
Medical Education Grants Manager
(MEGM) and Grants Review Committee
Review
Decision/Approver
Notification of LOA*
Check
Sent
LOA Signoff by
Provider**
Initial
Review
• Application is reviewed for completeness of the application package
• Providers will receive notification if additional information is required and will have 10 business
days to provide additional information to IMED
• Providers will be reminded once of requests for additional information
• If additional information is not received within the allotted time, the grant request may be denied
• Process can take 1 to 2 weeks
MEGM and
Grants
Review
Committee
Review
• Application is reviewed by MEGM, who reviews the request for all relevant criteria
• Application is reviewed by Grant Review Committee and a funding decision is made
• Process can take 2 to 6 weeks
• Providers will be required to agree to the terms of the LOA prior to the start of the program; this
timeframe has been included as part of the 60-day turnaround commitment
We commit to a 60-day decision turnaround for all grant requests (turnaround time begins
60 days after complete grant application is received)
Notification of decision will occur within 60 days
If the request is approved, payment may take up to 45-50 days after the date the approval
was communicated
* Assuming approval of grant
**Assuming acceptance by provider
42
Reasons for Delay in Review Process
The following issues often contribute to delays in
the grant application review process:
IRS W9 form not signed
Needs assessment not robust (lack of detail)
Questionable or unclear budget line items
Provider expertise and experience inquiries
Request for provider to complete an online
Request for Information (RFI)
Lack of clarity on compliance-related items
Internal legal/compliance counsel required
43
Independent Medical Education (IME)
Grant Process
1 2 3 4
Grant
ApplicationBefore You
Begin
IMED Application
Review
Implementation
Phase
5 6
Grant
Decision
Post Activity
Reconciliation
44
Decision and LOA Timeline and Rationale
Wk 1 Wk 2 Wk 3 Wk 4 Wk 5 Wk 6 Wk 7 Wk 8Wk 8 Wk 9Wk 9 Wk 10Wk 10 Wk 11Wk 11 Wk 12Wk 12
Initial
Review
Medical Education Grants Manager
(MEGM) and Grants Review Committee
Review
Decision/Approver
Notification of LOA*
Check
SentLOA Signoff by
Provider**
Decision/
Approver
Notification of
LOA
• If the grant is approved, an electronic LOA with the terms and
conditions of the funding will be sent to all relevant parties for
signature—once LOA is signed by the parties, payment process is
initiated
LOA Signoff by
Provider
• LOA must be electronically signed by provider and third party (if
applicable) prior to the start of the activity
Check Sent
• Check will be sent approximately 45 days after LOA is signed by all
relevant parties.
We commit to a 60-day decision turnaround for all grant requests (turnaround time begins
60 days after complete grant application is received)
Notification of decision will occur within 60 days
If the request is approved, payment may take up to 45-50 days after the date the approval
was communicated.
* Assuming approval of grant
**Assuming acceptance by provider
45
Grant Decision
Application ReviewApplication Review
ApprovalApproval DenialDenial
* Please contact the Grant Managers directly with questions regarding a grant decision.
46
Grant Decision: Approvals
ApprovalApproval
• Provider requesting the grant is notified via e-mail that grant is approved, pending
execution of the LOA
• Link to LOA is included in the e-mail
• Hardcopy of LOA can be obtained by printing from your browser prior to pressing “Submit”
• LOAs must be signed prior to planned activity start date or grant may be denied. By
signing the LOA you agree to:
• Be contacted by a third-party organization that posts educational programs to a disease
education website; approval of grant request is not contingent on actual participation
• Acknowledge Genentech’s financial support and that of it’s partners, if applicable
• Provide activity implementation status updates and reconciliation of expenses and or
operational components upon request. This is not for management or control purposes but
for assurance that the activity and grant funds are being executed per the application
• Approval of LOAs by Third Parties in GMA
• Accrediting organizations and logistics providers named in the grant request must all agree
to the terms in the LOA
- Accrediting organizations will be sent a link to approve the LOA online
- Providers will be responsible for obtaining signatures from logistics providers
47
Grant Decision: Denials
DenialDenial
• Provider requesting the grant is notified of denial via e-mail.
• Common Reasons for Denial
1. Not an area of educational interest
2. Budget limitations
3. Not compliant with relevant laws, regulations, guidelines and/or Genentech policies
4. Quality of request
5. Submitted less than 60 days prior to planned activity start date
6. No response to request for additional information
7. Parties cannot agree to the terms of the LOA
48
Independent Medical Education (IME)
Grant Process
1 2 3 4
Grant
ApplicationBefore You
Begin
IMED Application
Review
Implementation
Phase
5 6
Grant
Decision
Post Activity
Reconciliation
49
Implementation Phase Requirements
and Optional Assistance
Monthly implementation updates versus additional status
reports
Optional activity assistance:
Upon request, we can assist providers with the following:
1. Invitation distribution
2. Use of Genentech logo
50
Implementation Updates &
Status Reports
Online monthly updates required during program
implementation phase
IMED link provided to log ongoing updates and program changes (date,
location, etc.)
Updates not provided as means of program control, but to ensure
program is progressing
No changes? Click “no updates/changes available”
Additional status reports may be requested by IMED
IMED to notify providers by email if the additional status reports are
required
Status reports to include additional details regarding program’s
progession
* This is not for the purpose of managing or directing the execution of an
activity, but to provide assurance that the activity is being implemented in a
manner consistent with the grant application.
51
Supplemental Invitation Distribution
All requests for invitation distribution must be submitted
in writing to IMED only.
Genentech may only supplement the invitation process for the provider
Intent to request assistance must be indicated in original grant request
Formal written request must be submitted together with final invitation
Requests must be submitted and approved prior to activity start date
Approved invitation will be distributed to field-based personnel via Genentech’s distribution channels
Providers may not distribute invitations to any field-based personnel directly
Provider will be responsible for shipping charges
Genentech review of invitations may take up to three weeks
In addition, allow one to two weeks for fulfillment and distribution to field-based personnel by Genentech logistics partner
Genentech recommends allowing three to four weeks of field distribution
Note: Not all requests for assistance will be approved.
52
Use of Genentech LogoLogo License Agreement
• Providers are required to recognize Genentech’s grant
support, but are not obligated to use the Genentech logo
The Genentech logo should NEVER be used without a
signed logo license agreement in place.
Contact IMED to obtain permission to use the Genentech
logo and to begin the logo license agreement process
The logo license agreement should be between Genentech
and the accredited provider
53
Use of Genentech LogoGenentech Name or Logo
The Genentech logo should NEVER be used without a
signed logo license agreement in place.
•The Genentech logo can be used … on program materials and invitations for specific independent medical education events and enduring materials, if a logo license agreement is in place
•The Genentech logo should never be used … on a grant requestor’s external website, UNLESS it is in relation to a specific independent medical education activity, AND a logo license agreement is in place
• If permission to use the Genentech logo is not granted … please recognize Genentech, using our name and collaboration partner if applicable, only in accordance with the terms of the LOA
54
Independent Medical Education (IME)
Grant Process
1 2 3 4
Grant
Application
Before You
BeginIMED Application
Review
Implementation
Phase
5 6
Grant
Decision
Post Activity
Reconciliation
55
Reconciliation
IMED will require reports as part of its regular post-activity reconciliation process within 90 days of the activity end date
* Failure to reconcile may result in future grant requests not being considered The purpose of this reconciliation is to provide assurances that the activity was implemented per the proposed grant request.
Components of the ReconciliationComponents of the Reconciliation
1. Final activity report
a. Type of event/activity
b. Number and format of event(s)/component(s) in activity
c. Estimated and actual number of participants by audience type/specialty
d. Number of credit hours offered per activity, and total number of credit hours issued
2. Final agenda
3. Final invitation(s)/e-mail blasts
4. Final handout materials/screenshots of Web activity
5. Summarized results of Participant Evaluation
6. Summarized results of Faculty Evaluation (if available)
7. Other Educational Effectiveness Assessment results (if available)
8. Financial reconciliation (unused funds ≥ $250 to be returned)
56
Agenda
What is IMED?
What is the process for requesting independent
medical education grant funding from Genentech?
What tools and resources are available to me?
Q & A
57
Contact Information
Contact IMED by phone, fax, or online:
Phone
(866) 599-4363
Live Staff Hours of Operation: Monday - Friday 7:00 am – 5:00 pm PT
Majority of calls returned within 24 hours
Fax
(866) 301-8891
Online
E-mail: imed@gene.com
Further information and FAQs can be found at: www.imed.gene.com
www.grants.gene.com for a description of all grants and contributions that
Genentech supports
58
Additional Resources
The following websites and resources provide information
that will be helpful while completing a grant application:
Resource page on www.imed.gene.com
Office of Inspector General (OIG) Guidelines (www.oig.hhs.gov)
Accreditation Council for Continuing Medical Education (ACCME) Standards
for Commercial Support (www.accme.org)
Pharmaceutical Research and Manufacturers of American (PhRMA) Code on
Interactions with Healthcare Professionals (www.phrma.org)
American Medical Association (AMA) Ethical Guidelines for Gifts to
Physicians from Industry (www.ama-assn.org)
FDA Guidance on Industry-Supported Scientific and Educational Activities
(www.fda.gov)
MedDigest (www.meddigest.com) - Resource for independent medical
education programs, searchable by profession, therapeutic area and location
Alliance for CME (www.acme-assn.org) - Resource for continuing medical
education assessment tools and data
59
Independent Medical Education (IME)
Grant Process: Recap
1 2 3 4
Grant
Application
Before You
BeginIMED Application
Review
Implementation
Phase
5 6
Grant
Decision
Post Activity
Reconciliation
Providers must
ensure that grant
requests meet
IMED criteria
New requestors
must first
register online
(accept
Genentech’s
Compliance
Commitment;
ensure firewall
compliance;
submit signed
IRS W9)
Grant requests
must be
submitted via
www.imed.gene.
com
Requests must
be submitted no
less than 60
calendar days
prior to the
planned activity
start date or the
date the
requestor
requires a
decision
(whichever is
earlier)
IMED will review
requests to
ensure that
activities are
compliant, fair-
balanced,
scientifically
rigorous, and
unbiased
The review
process can take
up to 60 calendar
days
IMED provides
limited optional
activity
assistance upon
request
IMED will request
monthly updates
during program
implementation
and may request
additional status
reports
IMED will
approve or deny
the grant request
Providers will be
notified of the
grant decision
via e-mail
IMED will require
reconciliation of
all funded
activities within
90 days of the
completion of
the activity
60
Agenda
Genentech, Medical Education Support and IMED
What is the process for requesting independent
medical education grant funding from Genentech?
What tools and resources are available to me?
Q & A
Thank you!
• Please take a few moments to complete the brief
evaluation.
• We appreciate your participation and feedback!
61
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