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!

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