Scientific Advice Application Form Home Collaboration and Outreach Scientific Advice Application Form About Who We Are Board of Directors Executive Team How We Do It Methods & Guidelines Planning Documents Conflict of Interest Inclusion, Diversity, Equity, and Accessibility Statement Statement of Reconciliation What We Do 2025–2028 Strategic Plan 2022-2025 Strategic Plan Programs and Services Reimbursement Review Health Technology Review Horizon Scan Scientific Advice Program Scientific Advice Application Scientific Advice Application Form About the Scientific Advice Program Scientific Advice Offered at Different Time Points Scientific Advice Program Offerings Standard Scientific Advice Process Parallel Scientific Advice Expert Involvement in Scientific Advice Patient Involvement in Scientific Advice Confidentiality Conflict of Interest Security of Information Fee for Scientific Advice Frequently asked Questions How Are We Doing? Annual Reports Financial Statements Evaluation Reports Collaboration / Outreach Pan-Canadian Collaborative Advisory Bodies Appropriate Use Advisory Committee Canadian Drug Expert Committee (CDEC) Patient and Community Advisory Committee PCAC Meeting Summaries Pharmaceutical Advisory Committee Pharmaceutical Advisory Committee Formulary Working Group for Health Technology Assessments The pCODR Expert Review Committee (pERC) Provincial Advisory Group (PAG) Pharmaceutical Advisory Committee Formulary Working Group Formulary Management Expert Committee (Interim) Device Advisory Committee (DAC) Health Technology Expert Review Panel Post-Market Drug Evaluation Advisory Committee PMDE Industry Task Force (September 2023 – April 2024) Call for Applicants Patient / Community Impact of Patient Involvement Become Involved Common Acronyms Framework for Engagement Patient Involvement in Organizational Governance Careers Contact Holiday Schedule 1. Information about the Applicant Name of pharmaceutical company Contact Name Contact Title Contact Email Contact Phone Number Billing Information (name, address, phone number, email) 2. Product Description Name of product (include chemical name, generic, and trade names) Product description and mechanism of action Intended indication and target population Expected place in therapy Dosage form and route of administration Dosing regimen (dose, frequency, duration) Type of drug product Type of drug product - Select -Chemically synthesizedBiologicRadiopharmaceuticalGene therapyCell therapy (e.g., chimeric antigen receptor T cells)Therapeutic vaccineOther… Enter other… Does the drug have a companion diagnostic test? Yes No 3. Stage of Development Describe the stage of development of the product Please indicate the stage of development Pre-pivotal trial (pivotal trial planning stage) Post-pivotal trial (pivotal trial protocols finalized) After a ‘do not reimburse’ recommendation from Canada’s Drug Agency (CDA-AMC) Phase I results expected to be included in the Briefing Book Yes No Unsure at this point Comment Phase II results expected to be included in the Briefing Book Yes No Unsure at this point Comment 4. Purpose of Application Reason for seeking our Scientific Advice 5. Scientific Advice Process Please indicate the type of Scientific Advice process being requested * Please indicate the type of Scientific Advice process being requested Standard Scientific Advice with CDA-AMC alone✓ Scientific Advice – Flexible Service (i.e., Customized Process)✓ Scientific Advice after a Do Not Reimburse recommendation from CDA-AMC✓ Parallel Scientific Advice with CDA-AMC and Health Canada with INESSS participating in an observatory role (note: this is available on a case-by-case basis)✓ Parallel Scientific Advice with CDA-AMC and the National Institute for Health and Care Excellence (NICE,UK)✓ 6. Proposed Scientific Advice Meeting Request a date for Scientific Advice meeting. Please contact us in advance to confirm preferred meeting availabilities. 7. Briefing Book Content Indicate specific questions or general topics of key questions that you plan to include in your Briefing Book (if known). Do you anticipate including questions related to economic evaluation in your Briefing Book? Yes No Unsure at this point If yes, please indicate the estimated number of economic questions and general topic(s) of planned questions (if known). 8. Declaration for the Scientific Advice Program at CDA-AMC Disclaimer for Scientific Advice✓ Read. Confidentiality Guidelines for our Scientific Advice✓ Read. Fee Schedule for Scientific Advice✓ Read. Parallel Scientific Advice (if applicable): agree to the disclosure and exchange of project information between participating organizations✓ Read. 9. Permission to Share Information With Patient Representatives Patient involvement is part of the Scientific Advice process for every application; however, confidential information from the applicant will be shared with patient representative(s) only with permission of the applicant, as provided below. The applicant hereby agrees that CDA-AMC may share the Briefing Book and / or the information in the Briefing Book with patient representative(s) involved in the application. Yes No For parallel Scientific Advice with CDA-AMC and NICE, the applicant hereby agrees that the patient representative(s) involved in the application to CDA-AMC may attend and participate in the Scientific Advice meeting. Yes No Not applicable 10. Person Providing Authorized Consent Name and title of person providing authorized consent on behalf of the applicant. Providing your name here indicates that you have authority to bind the applicant. Name and Title
