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“Independent Medical Education Support from Genentech

Provider Training”

The webinar will begin shortly.

If you need technical assistance please email us at [email protected]

You may also send us a message via the questions/chat box in the lower left-hand corner of your screen.

2

““Independent Medical Education Independent Medical Education Support from GenentechSupport from Genentech

Provider Training”Provider Training”September 6, 2007 at 2:00 PM ET, 1:00 PM CT, 12:00 PM MT, 11:00 AM PT September 6, 2007 at 2:00 PM ET, 1:00 PM CT, 12:00 PM MT, 11:00 AM PT

Trudi BloomMedical Education Grants Manager

Gisela PaulsenDirector, Independent Medical Education Department

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Please take a moment to answer the poll Please take a moment to answer the poll questions below.questions below.

How many people are participating in this webinar at your location today?

1234567

8 or more

4

Please take a moment to answer the poll Please take a moment to answer the poll questions below.questions below.

What is your provider type? Hospitals/Health Systems

Medical Schools

Medical Specialty Societies

State Specialty Societies Commercial Supporter

Federal Health Care Educators

Health Care Education

Associations

Medical Education and

Communication Company

Other

Have you ever requested a grant from Genentech for independent medical education?

Yes

No

5

AgendaAgenda

• 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

AgendaAgenda

• What is the Independent Medical Education Department (IMED)?

• What is the process for requesting independent medical education grant funding from Genentech?


• Q & A

7

IMED Vision, Mission, and GoalsIMED Vision, Mission, and Goals

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.

Manage Genentech’s continued commitment to supporting quality independent medical education that improves patient care.

8

Genentech’s IndependenceGenentech’s Independence

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.

Genentech Genentech will will NOT:NOT:

Genentech Genentech will will NOT:NOT:

Influence the development of

educational content

Influence the development of

educational content

Select educational methods or venueSelect educational methods or venue

Influence selection of presenters

and/or moderators

Influence selection of presenters

and/or moderators

Define educational needs or objectives

for an activity

Define educational needs or objectives

for an activity

Influence selection of persons “who will be in

a position of control over the content”

Influence selection of persons “who will be in

a position of control over the content”

9

AgendaAgenda

• What is IMED?

• What is the process for requesting What is the process for requesting independent medical education independent medical education grant funding from Genentech?grant funding from Genentech?


• Q & A

10

Medical Education Grant ProcessMedical Education Grant Process

1 2 3 4Grant

ApplicationGrant

EligibilityIMED Application

ReviewActivity

Execution

Providers must ensure that grant requests meet IMED criteria

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 may require providers to submit monthly status updates on activity execution

5 6

Grant Decision

Reconciliation

IMED will approve or deny the grant request

Providers will be notified of the grant decision via e-mail

IMED will require reconciliation reports within 90 days of the end date

11

1 2 3 4Grant

ApplicationGrant


ReviewActivity

Execution

5 6

Grant Decision

Reconciliation


12

Grant EligibilityGrant EligibilityCharitable and Charitable and

Patient ProgramsPatient Programs

IMEDIMED

Research and Research and DevelopmentDevelopment

Other SupportOther Support

For information on all types of grant requests considered by Genentech, please visit the all-grants portal at www.grants.gene.com.

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

13

Eligible ProvidersFirewall requirementsAccreditation

Eligible AudiencesHCPs in training

Therapeutic Areas of Interest

Educational Format

Ineligible Grant Requests

Grant CriteriaGrant Criteria

cc

dd

ee

bb

aa

14

Grant Criteria: Eligible ProvidersGrant Criteria: Eligible Providersaa

Community Hospitals / Community Hospitals / Health SystemsHealth Systems

Community Hospitals / Community Hospitals / Health SystemsHealth Systems

Professional Societies and Professional Societies and AssociationsAssociations

Professional Societies and Professional Societies and AssociationsAssociations

Academic InstitutionsAcademic InstitutionsAcademic InstitutionsAcademic Institutions

Medical Education and Medical Education and Communication CompaniesCommunication Companies

Medical Education and Medical Education and Communication CompaniesCommunication Companies

OtherOtherOtherOther

15

Grant Criteria: Eligible Providers Grant Criteria: Eligible Providers Firewall RequirementsFirewall 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

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

16

Grant Criteria: Eligible ProvidersGrant Criteria: Eligible ProvidersAccreditationAccreditation

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

aa

17

Grant Criteria: Eligible Audiences*Grant Criteria: Eligible Audiences*

Physicians (Primarily specialist-

focused)

Physicians (Primarily specialist-

focused)

Nurses / Nurse Practitioners

Nurses / Nurse Practitioners

PharmacistsPharmacists

Physician AssistantsPhysician Assistants

bb

Medical Directors, Case Managers, Pharmacy

Directors

Medical Directors, Case Managers, Pharmacy

Directors Practice Managers Practice Managers

Other Allied HCPsOther Allied HCPs HCPs in Training (i.e., fellows and residents)

HCPs in Training (i.e., fellows and residents)

*Varies by therapeutic area

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Grant Criteria: Eligible AudiencesGrant Criteria: Eligible AudiencesEducation Grants for HCPs in Training Education Grants for HCPs in Training

EligibilityEligibilityEligibilityEligibility

CriteriaCriteriaCriteriaCriteria

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

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 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.

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

19

Grant Criteria: Therapeutic Grant Criteria: Therapeutic Areas of InterestAreas of Interest

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 ImmunologyGeneral

Access to Therapy Education relevant to Payers,

Employers and Practice Managers

Priority for funding will be given to activities that focus on specific therapeutic areas of interest outlined by Genentech.

cc

20

Grant Criteria: Educational FormatGrant Criteria: Educational Format

Eligible activity formats include:

dd

LiveLiveSociety & Society &

Association Association Educational SupportEducational Support

Enduring MaterialEnduring Material

SymposiaSymposia

Multi-speaker Multi-speaker meetingsmeetings

Grand roundsGrand rounds

Web casts/online Web casts/online programsprograms

TeleconferencesTeleconferences

PrintPrint

CD ROMCD ROM

Web-based Web-based activitiesactivities

Educational Educational sessions at sessions at annual meetingannual meeting

Not Not generalgeneral support of the support of the overall meetingoverall meeting

21

Grant Criteria: Ineligible Grant RequestsGrant 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

ee

22


1 2 3 4Grant

ApplicationGrant


ReviewActivity

Execution

5 6

Grant Decision

Reconciliation

23

To Get StartedTo Get Started

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

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

24

Applying for a GrantApplying for a Grant

Note: Online system will not allow for submission of grants less than 60 days prior to the planned start date of the activity.

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.

25

Compliance Commitment 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

26

What We Look ForWhat We Look For

Needs assessment and Needs assessment and learning objectiveslearning objectives

Appropriate activity Appropriate activity format/instructional design format/instructional design for the intended target for the intended target audienceaudience

Activity content aligned Activity content aligned with needs assessment with needs assessment and learning objectivesand learning objectives

Creative and interactive Creative and interactive conceptsconcepts

Fair-balanceFair-balance

Scientific rigorScientific rigor

Provider expertise in Provider expertise in activity’s therapeutic activity’s therapeutic areaarea

Overall quality of Overall quality of activity and activity and implementation planimplementation plan

ComplianceCompliance

Grant requests are reviewed using the following criteria:

27

Grant Requestor and 3Grant Requestor and 3rdrd Parties PartiesGrant 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”

28

Required Information and Required Information and Documentation 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

29

Needs AssessmentNeeds AssessmentA 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 SourcesData SourcesData SourcesData Sources ExamplesExamplesExamplesExamples

1. Expert Data

Literature searches of peer-reviewed medical literature Practice guidelines and other published reports Advisory Board feedback Practitioner interactions

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

30

Learning Objectives and AgendaLearning 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.

31

Detailed Line-Item BudgetDetailed Line-Item Budget

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

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

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

32

Budget TemplateBudget Template

Introduction Definitions2 – Budget Enduring or Web1 – Budget Live1 – Budget Live

Activity Summary provides a highlight of the activity,

including activity type and cost

Grant Request Summary sums the total grant request (live

and enduring/web)

Genentech Cost and Total Cost are populated automatically from the

completed spreadsheet

33

Implementation Plan GuidelinesImplementation Plan Guidelines

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

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

Providers are required to submit an implementation plan for grant activities with budgets that are greater than or equal to $15,000.

34

Document Upload PageDocument 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

35

Application ChecklistApplication Checklist

Time Key Supporting Documents

•The application checklist will help ensure complete applications are submitted to IMED.

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

36

IME Grant ProcessIME Grant Process

1 2 3 4Grant

ApplicationGrant


ReviewActivity

Execution

5 6

Grant Decision

Reconciliation

37

Decision and Letter of Agreement (LOA)Decision and Letter of Agreement (LOA)Timeline and RationaleTimeline and Rationale

Wk Wk 11

Wk Wk 22

Wk Wk 33

Wk Wk 44

Wk Wk 55

Wk Wk 66

Wk Wk 77

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

38

Reasons for Delay in Review ProcessReasons for Delay in 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

The following issues often contribute to delays in the grant application review process:

39


1 2 3 4Grant

ApplicationGrant


ReviewActivity

Execution

5 6

Grant Decision

Reconciliation

40

Decision and LOA Timeline and RationaleDecision and LOA Timeline and Rationale

Wk 1

Wk 2

Wk 3

Wk 4

Wk 5

Wk 6

Wk 7

Wk Wk 88

Wk Wk 99

Wk Wk 1010

Wk Wk 1111

Wk Wk 1212

Initial Review

Medical Education Grants Manager (MEGM) and Grants Review Committee

Review

Decision/Approver Notification of LOA*

Check Sent

LOA 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 acceptance—once LOA is accepted 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 up to 45 days after LOA is accepted in GMA

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

41

Grant DecisionGrant DecisionApplication ReviewApplication Review

ApprovalApproval DenialDenial

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”

LOAs must be approved 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 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

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

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

42


1 2 3 4Grant

ApplicationGrant


ReviewActivity

Execution

5 6

Grant Decision

Reconciliation

43

Activity Execution 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.

44

Invitation DistributionInvitation DistributionAll 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.

45

Faculty RecommendationsFaculty Recommendations


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


46

Clinical Accuracy ReviewClinical Accuracy Review

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)



47

Use of Genentech LogoUse of Genentech LogoLogo License AgreementLogo 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

48

•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

The Genentech logo should NEVER be used without a signed logo license agreement in place.

Use of Genentech LogoUse of Genentech LogoGenentech Name or LogoGenentech Name or Logo

• 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.

49

Status ReportsStatus 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.

51


1 2 3 4Grant

ApplicationGrant


ReviewActivity

Execution

5 6

Grant Decision

Reconciliation

52

ReconciliationReconciliation IMED will require reports as part of its regular post-activity reconciliation process within

90 days of the activity end date

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

Components of the Reconciliation

Current Components

1. Final activity report a. Type of event/activityb. Number and format of event(s) / component(s) in activityc. Estimated and actual number of participants by audience

type/specialtyd. Number of credit hours offered per activity, and total number of

credit hours issued2. Final agenda 3. Final invitation(s) / e-mail blasts4. Final handout materials/screenshots of Web activity5. Participant evaluation summary 6. Faculty evaluation summary (if available)

Future Components

All current components, plus:1. Financial reconciliation

a. Unused funds ≥ $250 to be returned2. Educational effectiveness

53

AgendaAgenda

• What is IMED?• What is the process for requesting

independent medical education grant funding from Genentech?

• What tools and resources What tools and resources are available to me?are available to me?

• Q & A

54

Contact InformationContact 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: [email protected]

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

55

Additional ResourcesAdditional ResourcesThe 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)

56

Grant Process RecapturedGrant Process Recaptured

1 2 3 4Grant

ApplicationGrant


ReviewActivity

Execution

Providers must ensure that grant requests meet IMED criteria

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 may require providers to submit monthly status updates on activity execution

5 6

Grant Decision

Reconciliation

IMED will approve or deny the grant request

Providers will be notified of the grant decision via e-mail

IMED will require reconciliation reports within 90 days of the end date

57

AgendaAgenda

• What is IMED?• What is the process for requesting

independent medical education grant funding from Genentech?


• Q & AQ & A

58

““Independent Medical Education Independent Medical Education Support from GenentechSupport from Genentech

Provider Training”Provider Training”

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 September 10, 2007 at 4:00 PM ET, 3:00 PM CT, 2:00 PM MT, 1:00 PM PT

Gisela PaulsenDirector, Independent Medical Education Department

Trudi BloomMedical Education Grants Manager

The webinar will begin shortly.

Documents

Transcript of The webinar will begin shortly.