Promotional Materials- Business Processand TechnologyDirk K BethCEO, Mission3October 10th – 8:30 – 10:00
The views and opinions expressed in the following PowerPoint slides are      those of the individual presenter and should ...
Promotional MaterialDefined
PromotionMeans any activity undertaken, organized orsponsored by a member company which isdirected at healthcare professio...
Consistency of Product InformationIt is understood that national laws and regulations usuallydictate the format and conten...
Accurate and Not MisleadingPromotional information should be clear, legible, accurate,balanced, fair, and sufficiently com...
SubstantiationPromotion should be capable of substantiation either byreference to the approved labeling or by scientific e...
The Challenge
Promotion is marketing                                       Audio      Promotional Labeling                              ...
38,000 pieces in 200079,000 pieces in 20101. Decrease in the number of sales   representatives pounding the pavement from ...
Costs of promotional materialsDrug Information Association     www.diahome.org   11
Drug Information Association   www.diahome.org   12
Processes and costs related to               management of promotional               materials               Technology an...
Cost of managing promotional materials• “Medical is increasingly spending time  reviewing promotional materials”        – ...
eCTD - Promotional Material TypesDocument / Digital Asset              Audio    Promotional Labeling               Regulat...
Execution of process  Review   Review      Review                             Submit          Create                      ...
Organizational structure• Campaign Oriented Projects    – Product    – Market    – Release Date    – Media format
Technology to OptimizePromotional Materials Management
How does technology helpPromotional Materials Management technology• Reduce time to reviewed and approved materials by tra...
Systems associated with Promotional MaterialsManagement (not necessarily discreet systems)                                ...
Document Management Capabilities andRequirements• Metadata                                • Workflow  management          ...
Submission Management Requirements• eCTD submission                        • Outside of the eCTD  capability              ...
Full eCTD and Non-eCTD submission support• New FDA Module 1 supports Promotional  Materials   – Support for Audience      ...
eCTD - Promotional Material Types                              Audio    Promotional Labeling                              ...
•     MPEG-2-HD (High Definition Video)•     WMV-HD (High Definition Video)•     DVD-VR•     DVD+VR•     DVD-Video•     Mi...
Endpoints                                                               Instance   InstanceUpstream                       ...
Dirk’s Contact Info                     Dirk Karsten Beth | Chief Executive Officer | Mission3, Inc.                     @...
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Management of Life Science Promotional Material

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  • 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.
  • Management of Life Science Promotional Material

    1. 1. Promotional Materials- Business Processand TechnologyDirk K BethCEO, Mission3October 10th – 8:30 – 10:00
    2. 2. The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.Drug Information Association www.diahome.org 2
    3. 3. Promotional MaterialDefined
    4. 4. PromotionMeans any activity undertaken, organized orsponsored by a member company which isdirected at healthcare professionals to promote theprescription, recommendation, supply,administration or consumption of itspharmaceutical product(s) through all methods ofcommunications, including the internet. IFPMA (International Federation of Pharmaceutical Manufacturers – Code of PracticeDrug Information Association www.diahome.org 4
    5. 5. Consistency of Product InformationIt is understood that national laws and regulations usuallydictate the format and content of the product informationcommunicated on labeling, packaging, leaflets, data sheetsand in all promotional material. Promotion should not beinconsistent with locally approved product information.Respecting the requirement that promotion should beconsistent with the label and approved uses locally,healthcare professionals in developing countries shouldhave access to similar data to those being communicatedin developed countries.Drug Information Association www.diahome.org 5
    6. 6. Accurate and Not MisleadingPromotional information should be clear, legible, accurate,balanced, fair, and sufficiently complete to enable the recipient toform his or her own opinion of the therapeutic value of thepharmaceutical product concerned. Promotional informationshould be based on an up-to-date evaluation of all relevantevidence and reflect that evidence clearly. It should not misleadby distortion, exaggeration, undue emphasis, omission or in anyother way. Every effort should be made to avoid ambiguity.Absolute or all-embracing claims should be used with cautionand only with adequate qualification and substantiation.Descriptions such as “safe” and “no side effects” shouldgenerally be avoided and should always be adequately qualified.Drug Information Association www.diahome.org 6
    7. 7. SubstantiationPromotion should be capable of substantiation either byreference to the approved labeling or by scientific evidence.Such evidence should be made available on request tohealthcare professionals. Companies should dealobjectively with requests for information made in good faithand should provide data which are appropriate to thesource of the inquiry.Drug Information Association www.diahome.org 7
    8. 8. The Challenge
    9. 9. Promotion is marketing Audio Promotional Labeling Book RadioControlling the Carton Reply Card conversation Reprint CarrierStaying on message Aid Slides Catalog Sales CD-ROM Promotional – The marketingSample Telephone Direct Mail Drug message TV – The “accurateFile Card VideoandRelease product News therapeutic Exhibit benefit” message Video Form Econ www-banner Form Kit Primarily when Giveaway message changes that www-ecomm House Organ www-links Kit www-other Monograph www-soc-med Other www-website Press Release www-video Print Ad www-mobileDrug Information Association Print Otherwww.diahome.org 9
    10. 10. 38,000 pieces in 200079,000 pieces in 20101. Decrease in the number of sales representatives pounding the pavement from an all-time high of 100,000+ in 20062. Proliferation of new communications channels3. Significant shift in the way that people prefer to consume information.Just hitting stride of social mediaDrug Information Association www.diahome.org 10
    11. 11. Costs of promotional materialsDrug Information Association www.diahome.org 11
    12. 12. Drug Information Association www.diahome.org 12
    13. 13. Processes and costs related to management of promotional materials Technology and resources that can reduce time and cost of promotional materials managementDrug Informationwww.diahome.org Association 13
    14. 14. Cost of managing promotional materials• “Medical is increasingly spending time reviewing promotional materials” – While spending less time on other activities vs the previous year Bonk et alDrug Information Association www.diahome.org 14
    15. 15. eCTD - Promotional Material TypesDocument / Digital Asset Audio Promotional Labeling RegulatoryManagement Book Radio Marketing (internal) Carrier Reply Card½ Million Review Touch PointsMedia Production Software Carton Reprint Marketing (external)Collaboration Catalog Sales Aid CD-ROM Sales 100s Promotional SlidesWorkflowMillions of RecordsClaims Repository / Archive Direct Mail Drug Sample Telephone Medical TV Exhibit Legal 10 1000s Video News ReleaseeCTD Submission File Card10s of Millions of External ExposuresManagement Solution Form Econ Form Kit Video www-banner Executive ManagementRegulatory Information R&D www-ecommManagement Solution Giveaway House Organ www-links Health Authorities 100sMarketing and Sales www-other KitAnalytics Patients Monograph www-soc-medWebsite &Web Content Other www-website PrescribersManagement Press Release www-video Print Ad www-mobileProject Management Print Other
    16. 16. Execution of process Review Review Review Submit Create eCTD or Media Review Approve Medical Review Review Regulatory Marketing
    17. 17. Organizational structure• Campaign Oriented Projects – Product – Market – Release Date – Media format
    18. 18. Technology to OptimizePromotional Materials Management
    19. 19. How does technology helpPromotional Materials Management technology• Reduce time to reviewed and approved 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• Collaboration internally and externally ensures faster and fewer cycles• Electronic submission enablement• Management of all media typesDrug Information Association www.diahome.org 19
    20. 20. Systems associated with Promotional MaterialsManagement (not necessarily discreet systems) Document Website and Management Media Web Content Production Management Software Project Collaboration Management Promotional Marketing Materials and Sales Workflow Analytics Regulatory Information Claims Management eCTD Repository Solution Submission Management SolutionDrug Information Association www.diahome.org 20
    21. 21. Document Management Capabilities andRequirements• Metadata • Workflow management – Route – Submission Required – Review – Release dates – Approve – Media outlet targets – Submit – Budget • Where Used• Version control – Track one to many – Manage development uses of materials thus and approved versions track back to claims – Manage change etc • Referential IntegrityDrug Information Association www.diahome.org 21
    22. 22. Submission Management Requirements• eCTD submission • Outside of the eCTD capability – Pieces must be – Latest US regional developed to XML support (and adequately support within the communicate to the interface) reviewer – Ability to support file • See all sides of a 3D piece types supported by the • Be able to open video FDA format • Provide links directly to reference materialDrug Information Association www.diahome.org 22
    23. 23. Full eCTD and Non-eCTD submission support• New FDA Module 1 supports Promotional Materials – Support for Audience • Consumer • Professional – Promotional Material DocType • Promotional 2253 • Request For Advisory Launch • Request For Advisory Non-Launch • Presubmission Accelerated Launch • Presubmission Accelerated Non-launch • Promotional 503b
    24. 24. eCTD - Promotional Material Types Audio Promotional Labeling Book Radio Carrier Reply Card Carton Reprint Catalog Sales Aid CD-ROM Promotional Slides Direct Mail Telephone Drug Sample TV Exhibit File Card Video News Release Form Econ Video Form Kit www-banner Giveaway www-ecomm House Organ www-links Kit www-other Monograph www-soc-med Other www-website Press Release www-video Print Ad www-mobile Print Other
    25. 25. • MPEG-2-HD (High Definition Video)• WMV-HD (High Definition Video)• DVD-VR• DVD+VR• DVD-Video• Mini-DVD• CD-R and CD-RW• VHS• Please Note: the following file formats are acceptable: – .iso files – Audio_ts/video_ts folders that include the following formats: • .bup • .ifo • .vobDrug Information Association www.diahome.org 25
    26. 26. Endpoints Instance InstanceUpstream Instance Instance• Review Use locally• Approval Instance• Release Instance Instance Instance Instance Released Source Instance Use Locally Instance• Review Instance Instance• Approval• Release Instance Instance Use Locally InstanceDrug Information Association www.diahome.org 26
    27. 27. Dirk’s Contact Info Dirk Karsten Beth | Chief Executive Officer | Mission3, Inc. @dirkbeth @regtrack Group: Registration Tracking www.mission3.com dirk@mission3.comDrug Information Association 27 www.diahome.org
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