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

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  • Pharmaceutical companies selling in the US must carefully and completely manage the creation, approval, and submission of promotional material in order to comply with federal regulations.Companies often have incomplete processes and technology that leave them exposed to strict regulatory remediation. Ensuring compliance with both process and technology mitigates companies’ exposure and lays the foundation for a more efficient and future-proof Promotional Materials Management infrastructure.
  • Incomplete processes and technology that leave them exposed to strict regulatory remediation. Ensuring compliance with both process and technology mitigates companies’ exposure and lays the foundation for a more efficient and future-proof Promotional Materials Management infrastructure.Proliferation of new communications channels (social media, promotional videos on CNN.com and toutube.com, iPad, etc.)Costs related to management of promotional materialsCollaboration - Organizations are relying more on external people
  • As part of business practice, life science companies disseminate advertising materials and engage in activities that are promotional in nature. Promotional materials target either consumers or health care professionals and are disseminated via different types of media and forms of communication.The OPDP, a department of the US FDA, is responsible for the surveillance and enforcement of prescription drug advertising.The Food and Drug Administration, Department of Justice, Federal Trade Commission, state attorneys general and other agencies are increasingly taking pharmaceutical, medical device, and food and cosmetics companies to task for advertising and promotion practices deemed or suspected of being false, misleading or otherwise unlawful. In response, many FDA-regulated businesses are taking a defensive approach to minimizing risk.
  • What do they do?Provide written commentsReview complaints about alleged promotional violationsPolicy and guidance developmentReview labeling and promotional materialsCore launch review and TV ad reviewsEnforcementTraining and communications
  • Pharmaceutical companies are being fined over billions of dollars due to a drug manufacturer practices of improper marketing and failure to warn. If companies want to reduce the risk of massive fines, litigation costs, misconduct charges, guilty pleas, negative publicity and more, they need to have strict controls over their processes related to promotional materials management.
  • In 2013, OPDP received approximately 85,000 promotional pieces. The FDA has "zero tolerance" for companies who mislead patients or healthcare professionals (HCPs).High Priority Areas for OPDP's "Risk-Based Approach" to enforcement include (1) new products; (2) products with significant risks; (3) products cited for violations in past; (4) products cited in complaints; and (5) products with far reaching campaigns.The most common violation in 2013 was for companies who omitted or minimized the risk of their product.
  • Many stakeholders worried that the FDA would require companies to submit "interactive promotional material" as if it were a traditional printed advertisement. Should a company have to submit real-time reports for every tweet or Linkedin message it sends out? This would not only be impossible for some social media advertising (and highly burdensome for the rest), but the FDA would have to work around the clock to process each submitted social media post.
  • The guidance states that any material posted to a social media site controlled either directly or indirectly by a firm, must be submitted to FDA's Office of Prescription Drug Promotion (OPDP).
  • When new regulations are introduced that affect current promotional pieces in the field, companies need to know the status of each promotional piece that’s been affected. Companies need to keep strict version control on items to ensure that the most current item is being updated or used. People need to be able to access the materials from anywhere at any time. The related product approvals need to be tracked.
  • Efficiently plan campaigns and review content in real-time with colleagues across the globe.Securely approve all types of content, with full reference library and complete audit trail.Quickly distribute materials to affiliates across the globe and expire or withdraw content.allowing users to collaborate, approve, and share their way to powerful, credible materials, via a simple, efficient, and validation-ready process.
  • To ensure that promotional materials and activities comply with industry guidance and regulations, pharmaceutical companies usually establish promotional review committees (PRCs), which are cross-functional groups that include members from Medical Affairs, Legal, and Regulatory in order to take legal considerations and medical accuracy into account.The PRC is responsible for ensuring scientific accuracy, relevance, and completeness of clinical data; ensuring that claims are adequately supported by data; ensuring that claims and materials are consistent with current approved labeling; and determining the acceptability of references used to support claims.
  • When change happens it’s critical to KNOW where it will impactWhere used is criticalSystems and process to control the upstream development and release of information are only half of the battleEnsuring old and outdated information is replaced EVERYWHERE wins the war.
  • 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. Life sciences companies simply can no longer rely on file sharing or spreadsheets to keep track of the many versions of the dozens upon dozens of promotional pieces and supporting documentation produced to market their products. Legal, Regulatory,and Medical Information (MI) departments have many different responsibilities within the organization. In addition to the traditional roles of theseprofessionals, promotional review is a growing responsibility.
  • Since adoption of the eCTD standard, it has become necessary to update the administrative portion of the eCTD (Module 1) to reflect regulatory changes, to provide clarification of business rules for submission processing and review, to refine the characterization of promotional marketing and advertising material, and to facilitate automated processing of submissions
  • 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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