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Mission3 electronic Promotional Materials Management (eMPM) Webinar April, 23 2014

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Mission3 electronic Promotional Materials Management (eMPM) Webinar April, 23 2014

  1. 1. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Mission3 Promotional Materials Management Adair Turner, MS, RAC Director of Clinical and Regulatory Operations
  2. 2. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Learn how Promotional Materials Management technology can help you: • Gain visibility into your process • Obtain the current status of each piece of promotional material at any given moment • Ensure your claims are current across the globe • Simplify Medical, Legal, and Regulatory review • Reduce costs • Improve quality and Regulatory compliance • Respond quickly to Agency requests
  3. 3. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Challenges Incomplete processes and technology Lack of compliance New communications channels Costs Collaboration
  4. 4. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com The Office of Prescription Drug Promotion (OPDP)
  5. 5. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com • "To protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers.“ • http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsan dTobacco/CDER/ucm090142.htm OPDP Mission
  6. 6. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Compliance
  7. 7. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.comhttp://pharmamkting.blogspot.com/2012_11_01_archive.html
  8. 8. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Example – Social Media • With the rapid increase of promotion through real-time social media outlets, pharmaceutical companies have wondered how to properly follow the regulations in the digital age. • Promotions via tweet or Facebook post, for example, can be uploaded instantly, in large quantities, and, on Twitter at least, in a maximum 140 characters.
  9. 9. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Social Media Guidance Document Released
  10. 10. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com At the time of initial display, a firm should submit in its entirety all sites for which it is responsible on FDA Form 2253 or Form FDA 2301. For example, the firm should submit the comprehensive static product with the addition of the interactive or real-time components. Once every month, a firm should submit an updated listing of all non-restricted sites for which it is responsible or in which it remains an active participant and that include interactive or real-time communications. Firms need not submit screenshots Any subsequent changes should be annotated and resubmitted to the Agency on Form FDA 2253 or Form FDA 2301 at the time of initial display (i.e., resubmission). = a LOT of submissions Social Media Guidance Overview
  11. 11. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com
  12. 12. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Benefits of a Cloud based system designed specifically for Life Sciences • Collaborate with your colleagues globally • Approve and disseminate information • Simple, efficient, and validation-ready • Easily configurable to support the varied Codes of Practice in countries around the world • Provide access to key people, track versions and repurpose assets across multiple channels • Search and find assets easily
  13. 13. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Begin With the End in Mind Planning Review and Approval 2253 and/or Finalization Submission Archival Metrics and Reporting
  14. 14. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Review Review Review Execution of process Create Review Medical Review Legal Review Regulatory Approve Submit eCTD or Media
  15. 15. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Endpoints Released Source Use locally Instance Instance Instance Instance Instance Instance Instance Use Locally Instance Instance Instance Instance Instance Instance Use Locally Instance Instance Instance Upstream • Review • Approval • Release • Review • Approval • Release
  16. 16. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Technology Requirements • Regulatory submission capabilities • Track relevant metadata such as associated package insert version date, dosage form, indication, supply classification, etc. • Organize materials by campaign (launch, non- launch), claim, product, date, market (country/region), media format, etc. • Create assets • Find assets easily • Report on expiration, usage, where used
  17. 17. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com What’s Coming and When? 2014 Module 1 Implementation 2016 Mandatory eCTD Marketing Applications 2017 Mandatory eCTD INDs
  18. 18. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Full eCTD and Non-eCTD submission support • New FDA Module 1 supports Promotional Materials 4th Qtr. 2014
  19. 19. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Module 1 Update • Provide additional functionality – Promotional submissions for CDER – Grouped Submissions • Additional submission metadata to facilitate submission processing • Contact Information (e.g. regulatory, technical) • Submission Type – Submission ID • Submission Sub-Type – Sequence Number • Review and update M1 Headings and Hierarchy – Major changes to 1.15 Promotional Material – Heading attributes for 1.1 Forms and 1.15 • Provide flexibility to reduce possibility of DTD changes – Attribute values (e.g. submission-type, submission-sub-type) • Alignment with CDER/CBER business requirements and eCTD Version 4
  20. 20. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Updated Module 1
  21. 21. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Granularity
  22. 22. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com • Reduce time to review and approve materials by tracking every item through every step • Reduce costs associated with interactions with outside agencies, such as courier costs • Improve quality and compliance by ensuring processes and association of current supporting materials • Collect process metrics and improve the total process time through application of business intelligence • Collaborate internally and externally for faster and fewer cycles • Submit electronically with eCTD software • Manage all media types Promo Materials Management Technology
  23. 23. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Promotional Materials Document Management Media Production Software Collaboration Workflow Claims RepositoryeCTD Submission Management Solution Regulatory Information Management Solution Marketing and Sales Analytics Project Management Website and Web Content Management Systems associated with Promotional Materials Management (not necessarily discreet systems)
  24. 24. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Utilize Technology Request materials Assign tasks Track against milestones Assign resources Workflow Review and comment Track expected document due dates Report on expired assets Link to eCTD System Submit to FDA Track and Report on status of claims and assets
  25. 25. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Document Management Capabilities and Requirements • Metadata management – Submission Required – Release dates – Media outlet targets – Budget • Version control – Manage development and approved versions – Manage change • Workflow – Route – Review – Approve – Submit • Where Used – Track one to many uses of materials thus track back to claims etc • Referential Integrity
  26. 26. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Outside of the eCTD •Pieces must be developed to adequately communicate to the reviewer •See all sides of a 3D piece •Be able to open video format •Provide links directly to reference material eCTD submission capability •Latest US regional XML support (and support within the interface) •Ability to support file types supported by the FDA Submission Management Requirements
  27. 27. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com • System should have predefined search / reporting capabilities – Impact of label change – Slice and dice of • Campaigns • Materials • Usage • Issues • Reviews / Approvals Automatic Surveillance
  28. 28. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com Repository Configuratio n eDMS Electronic Document Management System eTMF Electronic Trial Master File VDR Virtual Data Room Project Management - Import MS Project plans to populate the folder configuration. Submissions Regulatory Submissions eMPM Electronic Management of Promotional Materials ToolsFeatures Audit Trail Configurabl e System Admin Single Sign- On (Claims-based authenticatio n) Full System Backup & Export Multiple Security Levels Cloud Storage Bulk UploadVersion Control (Check-in / out) Workflow & Email Notification s Digital and Electronic Signature Support HIPAA compliant BAA Multiple geographic copies Software & Hardware monitoring NSProtect Security Independently audited facilities and equipment CFR 21 Part 11 Compliance Security Best Practices Upgrade on demand Scanning Import & PDF Conversion Metadata Search & Full-Text Search Graphical & Exportable Reporting Configured to support DIA EDM RM
  29. 29. +1 602 957 2150 2198 E. Camelback Rd #205 Phoenix, AZ 85016 www.mission3.com DIA 29 Adair Turner Director of Clinical and Regulatory Operations 2198 E. Camelback Rd. Phoenix, AZ 85016 aturner@mission3.com 602.957.2150 x1004 office

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