Independent Medical Education Support from Genentech Provider

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“Independent
Medical Education
Support from Genentech
Provider Training”
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“Independent Medical Education
Support from Genentech
Provider Training”
September 6, 2007 at 2:00 PM ET, 1:00 PM CT, 12:00 PM MT, 11:00 AM PT
Gisela Paulsen
Director, Independent Medical Education Department
Trudi Bloom
Medical Education Grants Manager
2
Please take a moment to answer the poll
questions below.
How many people are
participating in this webinar
at your location today?
1
2
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4
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6
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8 or more
3
Please take a moment to answer the poll
questions below.
What is your provider type?
Hospitals/Health Systems
Medical Schools
Medical Specialty Societies
State Specialty Societies
Commercial Supporter
Federal Health Care Educators
Have you ever requested a
grant from Genentech for
independent medical
education?
Yes
No
Health Care Education
Associations
Medical Education and
Communication Company
Other
4
Agenda
• What is the Independent Medical Education
Department (IMED)?
• What is the process for requesting
independent medical education grant funding
from Genentech?
• What tools and resources are available to
me?
• Q&A
5
Agenda
• What is the Independent
Medical Education Department
(IMED)?
• What is the process for requesting
independent medical education grant
funding from Genentech?
• What tools and resources are available to
me?
• Q&A
6
IMED Vision, Mission, and Goals
Vision
Mission
Goals
Manage Genentech’s continued commitment to supporting
quality independent medical education that improves
patient care.
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.
Encourage and support the evolution of quality
independent medical education while ensuring alignment
with ACCME, AMA, PhRMA Code, OIG, and FDA
guidance.
7
Genentech’s Independence
Influence the
development of
educational content
Influence selection
of presenters
and/or moderators
Genentech
will NOT:
Define educational
needs or objectives
for an activity
Select educational
methods or venue
Influence selection of
persons “who will be in
a position of control
over the content”
Note: Genentech personnel 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.
8
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
9
Medical Education Grant Process
1
Grant
Eligibility
 Providers must
ensure that grant
requests meet
IMED criteria
2
3
Grant
IMED Application
Application
Review
 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, fairbalanced,
scientifically
rigorous, and
unbiased
 The review
process can take
up to 60 calendar
days
4
5
6
Grant
Decision
Activity
Execution
Reconciliation
 IMED will
approve or deny
the grant request
 Providers will be
notified of the
grant decision
via e-mail
 IMED provides
limited optional
activity
assistance upon
request
 IMED will require
reconciliation
reports within 90
days of the end
date
 IMED may
require providers
to submit
monthly status
updates on
activity
execution
10
Medical Education Grant Process
1
Grant
Eligibility
2
3
Grant
IMED Application
Application
Review
4
5
6
Grant
Decision
Activity
Execution
Reconciliation
11
Grant Eligibility
Charitable and
Patient Programs
IMED
Research and
Development
Other Support




Community and Charitable Activities
Patient Advocacy
Education Not for HCPs
Medical Foundation Support





Independent Medical Education (Live and Enduring)
Professional Society and Association Educational Support
Live Educational Activities
Print, Recorded, and Interactive, Computer-Based Programs
Travel Grants for Healthcare Professionals in Training



Research and Development Fellowships
Other Third-Party Awards to Fellows
Institutional Grants to Fund Research





Medical Association-Initiated Fellowship
Trade Society/Association Requests
General Organization, Meeting Support
Advertising
Promotional Exhibit/Display Space
For information on all types of grant requests considered by Genentech, please visit the allgrants portal at www.grants.gene.com.
12
Grant Criteria
a
Eligible Providers
Firewall requirements
Accreditation
b
Eligible Audiences
HCPs in training
c
Therapeutic Areas of Interest
d
Educational Format
e
Ineligible Grant Requests
13
a
Grant Criteria: Eligible Providers
Community Hospitals /
Health Systems
Academic Institutions
Professional Societies and
Associations
Medical Education and
Communication Companies
Other
14
a
Grant Criteria: Eligible Providers
Firewall Requirements
 Genentech prohibits providers* 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 seeking
funding from Genentech for an IME activity if the provider has a parent or sister
company conducting or that could potentially conduct promotional activities for
Genentech:

Separate employee/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
*Including parent or sister companies
 Monitoring of compliance policies
**List is not all-inclusive. Please see www.imed.gene.com for complete list of criteria
15
a
Grant Criteria: Eligible Providers
Accreditation
 Preference will be given to activities and initiatives that are
accredited for continuing healthcare professional
education (CME/CE)
 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 request the grant
funding from Genentech and is responsible for the activity
or initiative

Payment may be designated to an identified third party
16
b
Grant Criteria: Eligible Audiences*
Physicians
(Primarily specialistfocused)
Pharmacists
Nurses / Nurse Practitioners
Physician Assistants
Medical Directors, Case
Managers, Pharmacy
Directors
Practice Managers
Other Allied HCPs
HCPs in Training
(i.e., fellows and residents)
17
*Varies by therapeutic area
b
Grant Criteria: Eligible Audiences
Education Grants for HCPs in Training
Eligibility
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.
Criteria
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.
18
c
Grant Criteria: Therapeutic
Areas of Interest
Priority for funding will be given to activities that focus on
specific therapeutic areas of interest outlined by Genentech.
Allergic Disease
 Asthma
Oncology
 Breast Cancer
 Gastrointestinal Cancer
 General Oncology
 Glioma
 Non-Hodgkins Lymphoma
 Ovarian Cancer
 Renal Cancer
 Thoracic Cancer
Cardiovascular
 Acute Myocardial Infarction
Dermatology
 Psoriasis
Endocrinology
 Adult Growth Hormone Deficiency
 Disorders of Growth and
Development
Neurology
 Acute Ischemic Stroke
 Multiple Sclerosis
 Neuromyelitis Optica
Ophthalmology
 Macular Degeneration
 Vascular Permeability Disorders
Pulmonology
 Cystic Fibrosis
 Pulmonary Embolism
Rheumatology
 Arthritis
 Lupus
Thrombolytic Therapy
 Central Venous Device Restoration
General Immunology
General
 Access to Therapy
 Education relevant to Payers,
Employers and Practice Managers
19
d
Grant Criteria: Educational Format
Eligible activity formats include:
Live
 Symposia
 Multi-speaker
meetings
 Grand rounds
Society &
Association
Educational Support
 Educational
sessions at
annual meeting
 Not general
support of the
overall meeting
Enduring Material
 Print
 CD ROM
 Web-based
activities
 Web casts/online
programs
 Teleconferences
20
e


Grant Criteria: Ineligible Grant Requests
Grants for individuals or group practices
Retroactive support, including enduring materials
 Enduring materials based on a previously completed live activity
will not be considered





Travel, lodging, or registration expenses for non-faculty healthcare
professionals to attend an educational activity (some limited exception
for HCPs in training)
Capital or operating expenses
Stand-alone entertainment or social activities
Staff/professional development
Requests for exhibits or displays (providers may indicate there is an
opportunity for exhibits or displays)
 These may be requested from your field sales representative
Note: This is not an all-inclusive list
21
Medical Education Grant Process
1
Grant
Eligibility
2
3
Grant
IMED Application
Application
Review
4
5
6
Grant
Decision
Activity
Execution
Reconciliation
22
To Get Started
www.imed.gene.com
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
23
Applying for a Grant
Online Application:
Providers can register and apply for a grant directly on
www.imed.gene.com.
– Providers should save username and password information for future
grant applications
– Registration is to be renewed annually when notified by IMED
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
– If confirmation 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: Online system will not allow for submission of grants less than 60 days prior to the planned start date of
the activity.
24
Compliance Commitment
 By accepting commitment, grant requestors agree to comply with
relevant society and association guidelines, including, but not
limited to: ACCME, ACPE, CCRN, AAMC, ACCME, and PhRMA
 Other terms of the Compliance Commitment:
 Does not constitute or represent a funding commitment by
Genentech for the specified educational program
 If grant request is approved, Genentech’s actual provision to you of
grant funds will constitute its sole funding commitment for the
educational program
 Indicates that neither the requestor nor the requestor’s
organization is involved with any Genentech promotional activities,
or that an appropriate firewall exists
 Certifies that neither the requestor nor the requestor’s organization
is on the OIG, FDA, or ACCME debarment or exclusion lists
25
What We Look For
Grant requests are reviewed using the following criteria:
 Needs assessment and
learning objectives
 Fair-balance
 Appropriate activity
format/instructional design
for the intended target
audience
 Scientific rigor
 Activity content aligned
with needs assessment
and learning objectives
 Overall quality of
activity and
implementation plan
 Creative and interactive
concepts
 Compliance
 Provider expertise in
activity’s therapeutic
area
26
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
Designating Grant Payment
 Accredited providers may designate payment to a 3rd party logistics provider
Grant Notification and Letter of Agreement (LOA) Acceptance
 Currently, 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 a copy of the LOA is required, the LOA must be printed from the user’s web browser
prior to selecting “Submit”
27
Required Information and
Documentation
Grant requests will require the following information/
documentation:
 Signed IRS W9 form
 Needs assessment
 Activity learning objectives
 Proposed agenda and/or content outline
 Budget details for both the amount requested from
Genentech AND the total budget for activity

Genentech Excel budget form required
 Implementation plan*
* For activities with total budget ≥ $15,000
28
Needs Assessment
A needs assessment is an analysis of the data supporting the need for a particular
independent medical education activity.
Below are four examples of objective sources that could be used to validate need.
Data Sources
Examples
1. Expert Data




2. Market Research on
Professional Needs
 Focus panels
 Medical Communications 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
Literature searches of peer-reviewed medical literature
Practice guidelines and other published reports
Advisory Board feedback
Practitioner interactions
29
Learning Objectives and Agenda
•All grant applications must include the activity’s learning objectives along
with a copy of the activity’s agenda and/or content outline.
Learning
Objectives
Must…
1 Clearly state what participant will learn from the activity
2 Clarify to grant reviewers the purpose of the activity
3 Be consistent with the needs assessment
1 Clarify the content within the activity and their duration
The Agenda/
Show time devoted to education vs. meals and entertainment,
Content Outline 2
if applicable
Must…
3 Be consistent with the learning objectives
30
Detailed Line-Item Budget
 Budget details for both the amount requested from Genentech AND the total budget for
the activity will be requested.
 The budget template must be downloaded from www.imed.gene.com and upload where
indicated request.
 Total amount and Genentech total should be entered in the grant application where
indicated







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 hours of work)
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
31
Budget Template
Activity Summary provides a
highlight of the activity, including
activity type and cost
Genentech Cost and Total Cost are
populated automatically from the
completed spreadsheet
Introduction
1 – Budget Live
Grant Request Summary sums
the total grant request (live and
enduring/web)
2 – Budget Enduring or Web
Definitions
32
Implementation Plan Guidelines
Providers are required to submit an implementation plan for grant activities
with budgets that are greater than or equal to $15,000.
 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: Guidance available on website and in application
33
Document Upload Page
 The Document Upload Page will allow providers to upload the grant request’s
supporting documents
 The upload process is similar to uploading documents to an e-mail
 The following documents are required to be uploaded with your grant request:

Signed IRS W9 form

Activity learning objectives

Agenda and/or content outline

Details of budget amount requested from Genentech AND the total budget for
activity

Needs assessment* (level of detail required is contingent upon the total amount
of the activity budget)

Implementation plan*
* For total activity budgets ≥ $15,000
34
Application Checklist
•The application checklist will help ensure complete applications are submitted to
IMED.
Time

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 overshadowed by time allocated for
meals/entertainment, if applicable
Key Supporting Documents

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
Content

Activity is scientifically rigorous,
balanced, and unbiased

Request is in alignment with areas of
educational interest to Genentech
Other
Proposed faculty is appropriate for the
 content and educational objectives

Budget is reasonable, cost-effective,
and in line with fair market value
35
IME Grant Process
1
Grant
Eligibility
2
3
Grant
IMED Application
Application
Review
4
5
6
Grant
Decision
Activity
Execution
Reconciliation
36
Decision and Letter of Agreement (LOA)
Timeline and Rationale
 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
Wk
1
Wk
2
Wk
3
MEGM and
Grants
Review
Committee
Review
Wk
5
Wk
6
Wk
7
Medical Education Grants Manager
(MEGM) and Grants Review Committee
Review
Initial
Review
Initial
Review
Wk
4
Wk
8
Wk
9
Wk
10
Wk
11
Wk
12
Decision/Approver
Notification of LOA*
LOA Signoff by
Provider**
Check
Sent
• 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
•
•
•
•
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
* Assuming approval of grant
**Assuming acceptance by provider
37
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
38
IME Grant Process
1
Grant
Eligibility
2
3
Grant
IMED Application
Application
Review
4
5
6
Grant
Decision
Activity
Execution
Reconciliation
39
Decision and LOA Timeline and Rationale
 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
Wk
1
Wk
2
Initial
Review
Decision/
Approver
Notification of
LOA
LOA Signoff by
Provider
Wk
3
Wk
4
Wk
5
Wk
6
Wk
7
Medical Education Grants Manager
(MEGM) and Grants Review Committee
Review
Wk
8
Wk
9
Wk
10
Wk
11
Wk
12
Decision/Approver
Notification of LOA*
LOA Signoff by
Provider**
Check
Sent
• If the grant is approved, an electronic LOA with the terms and
conditions of the funding will be sent to all relevant parties for
acceptance—once LOA is accepted by the parties, payment process is
initiated
• LOA must be electronically signed by provider and third party (if
applicable) prior to the start of the activity
• Check will be sent up to 45 days after LOA is accepted
in GMA
* Assuming approval of grant
Check Sent
**Assuming acceptance by provider
40
Grant Decision
Application Review
Approval
Provider requesting the grant is notified via e-mail that grant
is approved, pending acceptance of the LOA
• A link to the LOA is included in the e-mail
• A hardcopy of the LOA can be obtained by printing from
your browser prior to pressing “Submit”
Denial
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
LOAs must be approved prior to planned activity start date or
grant may be denied
3. Not compliant with relevant laws, regulations, guidelines
and/or Genentech policies
4. Quality of request
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 participation
• Acknowledge Genentech’s financial support and that of it’s
partners, if applicable
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
• Provide activity implementation status updates and
reconciliation of expenses and or operational components
upon request
Approval of LOAs by Third Parties in GMA
• Accrediting organizations and logistics providers (if payee)
named in the grant request must 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
41
IME Grant Process
1
Grant
Eligibility
2
3
Grant
IMED Application
Application
Review
4
5
6
Grant
Decision
Activity
Execution
Reconciliation
42
Activity Execution
 Optional activity assistance
 Upon request, we can assist providers with the
following:
1. Invitation distribution
2. Faculty recommendations
3. Clinical accuracy review
4. Genentech logo
 Activity status reports
All requests must be submitted in writing to IMED only.
43
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 with Field Direction Memo will be distributed to field-based
personnel via Genentech’s distribution channels
 Providers should 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 the Genentech warehouse
 Genentech recommends allowing three to four weeks for field distribution
 Note: Not all requests for assistance will be fulfilled.
44
Faculty Recommendations
All requests must be submitted in writing to IMED only.
 Genentech will provide at least three names for every one
speaker/faculty/author requested
 Providers are solely responsible for independently selecting
faculty
 Faculty should disclose any financial or other arrangements with
supporting organizations
Note: Not all requests for assistance will be fulfilled.
45
Clinical Accuracy Review
All requests must be submitted in writing to IMED only.
 Genentech will only review data that is pertinent to Genentech’s
products
 Genentech will not script or supply data, cases, draft text, or any
other type of guidance in any of the slides and/or material
prepared for the activity’s presentation
 Please allow as much time as possible for review (minimum of
two weeks)
Note: Not all requests for assistance will be fulfilled.
46
Use of Genentech Logo
Logo License Agreement
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 or other non-profit entity
47
Use of Genentech Logo
Genentech 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, by not-for-profit
organizations only, 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, the entity
requesting the logo is a non-profit organization, AND a logo
license agreement is in place
• If permission to use the Genentech logo is not granted …
please recognize Genentech, using our name only, in
accordance with the terms of the LOA.
48
Status Reports
All status reports must be submitted to IMED only.
 IMED requires status updates on implementation of larger activities
(≥$250,000)
 IMED may request status reports for any activity
 IMED will provide a standard template with the request
 Status report template is available on www.imed.gene.com under
“Resources”
 All status reports must be submitted on this template
 Status reports must be submitted monthly
 IMPORTANT: Please inform IMED of any changes to the execution of
your activity in your status update
 Date/timeline changes, format changes, etc.
49
Medical Education Grant Process
1
Grant
Eligibility
2
3
Grant
IMED Application
Application
Review
4
5
6
Grant
Decision
Activity
Execution
Reconciliation
51
Reconciliation
 IMED will require reports as part of its regular post-activity reconciliation process within
90 days of the activity end date
Components of the Reconciliation
1.
Current Components
2.
3.
4.
5.
6.
Future Components
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
Final agenda
Final invitation(s) / e-mail blasts
Final handout materials/screenshots of Web activity
Participant evaluation summary
Faculty evaluation summary (if available)
All current components, plus:
1.
Financial reconciliation
a.
Unused funds ≥ $250 to be returned
2.
Educational effectiveness
Note:
 Failure to reconcile may result in future grant requests not being considered
 Providers should not send IMED supplemental program evaluation reports for educational
effectiveness at this time
52
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
53
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 PST

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
54
Additional Resources
The following websites provide information that will be helpful
while completing a grant application:
 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)
55
Grant Process Recaptured
1
Grant
Eligibility
 Providers must
ensure that grant
requests meet
IMED criteria
2
3
Grant
IMED Application
Application
Review
 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, fairbalanced,
scientifically
rigorous, and
unbiased
 The review
process can take
up to 60 calendar
days
4
5
6
Grant
Decision
Activity
Execution
Reconciliation
 IMED will
approve or deny
the grant request
 Providers will be
notified of the
grant decision
via e-mail
 IMED provides
limited optional
activity
assistance upon
request
 IMED will require
reconciliation
reports within 90
days of the end
date
 IMED may
require providers
to submit
monthly status
updates on
activity
execution
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
This session will be repeated live on
September 10, 2007 at 4:00 PM ET, 3:00 PM CT, 2:00 PM MT, 1:00 PM PT
“Independent Medical Education
Support from Genentech
Provider Training”
Gisela Paulsen
Director, Independent Medical Education Department
Trudi Bloom
Medical Education Grants Manager
58
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