europe Drug Master File

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1 : The SNM Centralized IND & Clinical Trials Network Enabling Implementation Investigational & Approved PET Imaging in Large Multicenter Clinical Trials George Q. Mills, MD, MBA September 9, 2009
2 : PET imaging desired for Multicenter Therapeutic Trials …but…numerous deficiencies… Lack of… Limited supply of investigational PET agents Standardized PET imaging acquisition protocols Harmonized PET imaging report output Qualified & experienced imaging centers large (200+ sites) multicenter clinical trials Industry could not effectively implement PET imaging in multicenter therapeutic clinical trials Therapeutic Drug Developers Comments
3 : SNM – Assessment Efforts Therapeutic Developers Participating PET Imaging Centers FDA – Pre-IND Process Results - Design solutions Centralized Investigational PET Imaging IND to Enable Therapeutic Developers’ Multicenter Therapeutic Clinical Trials Distributed Manufacturing Investigational PET imaging Agents
4 : SNM Centralized IND Demonstration Project - Future development INDs F-18 FLT – first choice – available – broad potential Regulatory CMC Imaging Standardization
5 : Investigator international site registry Forming “Pick List” - therapeutic developers Enrollment & qualifications Location Geography Patient population access Equipment – hardware & software Personnel Access to investigational imaging agents Participation – phantom program – clinical trials Clinical Trials Sites Network - Registry
6 : World wide interest - imagers & manufacturers
7 : Regulatory – multicenter IND manufacturing Multicenter INDs - “Single source” – investigational product CMC – Investigational F-18 FLT sources Multiple production sites & multiple methods “Distributed manufacturing” = multiple end-product specs SNM Centralized IND F-18 FLT FDA CMC review of all sources – acceptable ranges for end-product specifications
8 : Review through submission to IND file directly or through Drug Master File (DMF) “a submission tool of efficiency for manufacturers” Information concerning the Chemistry, Manufacturing and Controls (CMC) of a drug product or a component of a drug product to permit the FDA to review this information upon request in support of a submission
9 : Types of DMFs Five Types I: Plant information II: Drug substance, drug product, intermediates and material used in their manufacture III: Packaging IV: Excipients V: Other clinical, tox
10 : Who must file a DMF? CMC information must be available for IND review: CMC must be in an IND submission or in a DMF There is no legal or regulatory requirement to file a DMF (submission by Holder,…ref by applicant or authorized party) Applicant submits a Letter of Authorization (LOA) from the Holder with their IND submission
11 : Letter of Authorization (LOA) – Enabling review of DMF The DMF will be reviewed ONLY when it is referenced in a submission or another DMF (initially receives an administrative review) The Holder MUST submit an LOA (2 copies) to the DMF and send a copy to the Applicant The Applicant submits LOA in their submission… the mechanism to trigger review of the DMF by FDA In Europe, the LOA is called a Letter of Access
12 : DMF Advantages Maintains proprietary information/trade secrets (e.g. manufacturing procedure) belonging to the Holder, from being revealed to the Applicant while permitting review by FDA Permit review of information referenced by a number of applicants & will be used to support submissions from many sponsors Time efficient – cost effective
13 : Imaging standardization Pre-clinical Imaging Standardization - Imaging Phantom Program Oncology – CNS - Cardiovascular Clinical imaging - Standardized protocol International imaging clinical site registry (217 sites) documentation of equipment & demonstrated capabilities Clinical Trials Educational programs – Multicenter Trials
14 : F-18 fillable phantoms Qualitative & Quantitative (SUV) VA system Torso – Oncology ? Head – CNS Cardiac SNM Imaging Phantom Program
16 : Topics Overview – Key Elements – Centralized IND Clinical Trials Network Resources Sites Registry Phantom Program Education & Training Program F-18 FLT selection
17 : Thank you George Mills, MD, MBA Vice President, Medical & Regulatory Relations Perceptive Informatics
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