“ Independent Medical Education Support from Genentech Provider Training ” The webinar will begin shortly. If you need technical assistance please us at 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 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 Trudi Bloom Medical Education Grants Manager Gisela Paulsen Director, Independent Medical Education Department

3 Please take a moment to answer the poll questions below. Please take a moment to answer the poll questions below. How many people are participating in this webinar at your location today? or more

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

7 IMED Vision, Mission, and Goals Goals Mission Vision 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 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 will NOT: Influence the development of educational content Select educational methods or venue Influence selection of presenters and/or moderators Define educational needs or objectives for an activity Influence selection of persons “who will be in a position of control over the content”

9 Agenda What is IMED? What is the process for requesting independent medical education grant funding from Genentech?What is the process for requesting independent medical education grant funding from Genentech? What tools and resources are available to me? Q & A

10 Medical Education Grant Process 1234 Grant Application Grant Eligibility IMED Application Review Activity Execution  Providers must ensure that grant requests meet IMED criteria  Grant requests must be submitted via 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 56 Grant Decision Reconciliation  IMED will approve or deny the grant request  Providers will be notified of the grant decision via  IMED will require reconciliation reports within 90 days of the end date

Grant Application Grant Eligibility IMED Application Review Activity Execution 56 Grant Decision Reconciliation Medical Education Grant Process

12 Grant Eligibility Charitable and Patient Programs IMED Research and Development Other Support For information on all types of grant requests considered by Genentech, please visit the all- grants portal at  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 Providers  Firewall requirements  Accreditation Eligible Audiences  HCPs in training Therapeutic Areas of Interest Educational Format Ineligible Grant Requests Grant Criteria c d e b a

14 Grant Criteria: Eligible Providers a Community Hospitals / Health Systems Professional Societies and Associations Academic Institutions Medical Education and Communication Companies OtherOther

15 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  Monitoring of compliance policies *Including parent or sister companies **List is not all-inclusive. Please see for complete list of criteria a

16 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 a

17 Grant Criteria: Eligible Audiences* Physicians (Primarily specialist- focused) Physicians (Primarily specialist- focused) Nurses / Nurse Practitioners Pharmacists Physician Assistants b Medical Directors, Case Managers, Pharmacy Directors Practice Managers Other Allied HCPs HCPs in Training (i.e., fellows and residents) HCPs in Training (i.e., fellows and residents) *Varies by therapeutic area

18 Grant Criteria: Eligible Audiences Education 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: 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. b

19 Grant Criteria: Therapeutic Areas 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 Immunology General  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. c

20 Grant Criteria: Educational Format Eligible activity formats include: d Live Society & Association Educational Support Enduring Material  Symposia  Multi-speaker meetings  Grand rounds  Web casts/online programs  Teleconferences  Print  CD ROM  Web-based activities  Educational sessions at annual meeting  Not general support of the overall meeting

21 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 e

22 Medical Education Grant Process 1234 Grant Application Grant Eligibility IMED Application Review Activity Execution 56 Grant Decision Reconciliation

23 To 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

24 Applying 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 –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 will be sent to the provider. –Users should check their 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  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 For  Needs assessment and learning objectives  Appropriate activity format/instructional design for the intended target audience  Activity content aligned with needs assessment and learning objectives  Creative and interactive concepts  Fair-balance  Scientific rigor  Provider expertise in activity’s therapeutic area  Overall quality of activity and implementation plan  Compliance Grant requests are reviewed using the following criteria:

27 Grant Requestor and 3 rd 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 3 rd 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 indicating that they have been named as the accredited provider  If the grant is approved, the accredited provider receives a second 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 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 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 ExamplesExamples 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 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… 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 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 and upload where indicated request.  Total amount and Genentech total should be entered in the grant application where indicated

32 Budget Template IntroductionDefinitions2 – Budget Enduring or Web 1 – 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 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 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  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 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 Process 1234 Grant Application Grant Eligibility IMED Application Review Activity Execution 56 Grant Decision Reconciliation

37 Decision and Letter of Agreement (LOA) Timeline and Rationale Wk 1 Wk 2 Wk 3 Wk 4 Wk 5 Wk 6 Wk 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 days after the date the approval was communicated * Assuming approval of grant **Assuming acceptance by provider

38 Reasons 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 IME Grant Process 1234 Grant Application Grant Eligibility IMED Application Review Activity Execution 56 Grant Decision Reconciliation

40 Decision and LOA Timeline and Rationale Wk 1 Wk 2 Wk 3 Wk 4 Wk 5 Wk 6 Wk 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** 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 days after the date the approval was communicated * Assuming approval of grant **Assuming acceptance by provider

41 Grant Decision Application Review ApprovalDenial Provider requesting the grant is notified via that grant is approved, pending acceptance of the LOA A link to the LOA is included in the 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 . 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 IME Grant Process 1234 Grant Application Grant Eligibility IMED Application Review Activity Execution 56 Grant Decision Reconciliation

43 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 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.

45 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.

46 Clinical 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) Note: Not all requests for assistance will be fulfilled. All requests must be submitted in writing to IMED only.

47 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

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 Logo Genentech 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 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 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.

50 Scientific Data Dissemination Requests  Genentech personnel may not provide presentations or other materials for use by a third-party speaker in an independent medical education activity  Development personnel may provide a third-party speaker specific scientific slides from a presentation provided that:  The speaker independently selected the content and the specific information requested, AND  The speaker independently determines how to use such graphs or data in his/her presentation, AND  Genentech personnel do not make independent judgments about what material is appropriate for such third-party speaker presentations Note: Authorized Genentech personnel may distribute other non-promotional materials in response to an unsolicited request regarding Genentech products, in compliance with internal policy guidelines.

51 Medical Education Grant Process 1234 Grant Application Grant Eligibility IMED Application Review Activity Execution 56 Grant Decision Reconciliation

52 Reconciliation  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/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) / blasts 4.Final handout materials/screenshots of Web activity 5.Participant evaluation summary 6.Faculty evaluation summary (if available) Future Components All current components, plus: 1.Financial reconciliation a.Unused funds ≥ $250 to be returned 2.Educational effectiveness

53 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?What tools and resources are available to me? Q & A

54 Contact Information Contact IMED by phone, fax, or online: Phone  (866)  Live Staff Hours of Operation: Monday - Friday 7:00 am – 5:00 pm PST  Majority of calls returned within 24 hours  Fax  (866)  Online   Further information and FAQs can be found at:  for a description of all grants and contributions that Genentech supports

55 Additional Resources The following websites provide information that will be helpful while completing a grant application:  Office of Inspector General (OIG) Guidelines (  Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support (  Pharmaceutical Research and Manufacturers of American (PhRMA) Code on Interactions with Healthcare Professionals (  American Medical Association (AMA) Ethical Guidelines for Gifts to Physicians from Industry (  FDA Guidance on Industry-Supported Scientific and Educational Activities (

56 Grant Process Recaptured 1234 Grant Application Grant Eligibility IMED Application Review Activity Execution  Providers must ensure that grant requests meet IMED criteria  Grant requests must be submitted via 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 56 Grant Decision Reconciliation  IMED will approve or deny the grant request  Providers will be notified of the grant decision via  IMED will require reconciliation reports within 90 days of the end date

57 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 & AQ & A

58 “Independent Medical Education Support from Genentech 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 Gisela Paulsen Director, Independent Medical Education Department Trudi Bloom Medical Education Grants Manager