1. Promotional Materials
- Business Process
and Technology
Dirk K Beth
CEO, Mission3
October 10th – 8:30 – 10:00

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. Promotional Material
Defined

4. Promotion
Means any activity undertaken, organized or
sponsored by a member company which is
directed at healthcare professionals to promote the
prescription, recommendation, supply,
administration or consumption of its
pharmaceutical product(s) through all methods of
communications, including the internet.
IFPMA (International Federation of Pharmaceutical Manufacturers – Code of Practice
Drug Information Association www.diahome.org 4

5. Consistency of Product Information
It is understood that national laws and regulations usually
dictate the format and content of the product information
communicated on labeling, packaging, leaflets, data sheets
and in all promotional material. Promotion should not be
inconsistent with locally approved product information.
Respecting the requirement that promotion should be
consistent with the label and approved uses locally,
healthcare professionals in developing countries should
have access to similar data to those being communicated
in developed countries.
Drug Information Association www.diahome.org 5

6. Accurate and Not Misleading
Promotional information should be clear, legible, accurate,
balanced, fair, and sufficiently complete to enable the recipient to
form his or her own opinion of the therapeutic value of the
pharmaceutical product concerned. Promotional information
should be based on an up-to-date evaluation of all relevant
evidence and reflect that evidence clearly. It should not mislead
by distortion, exaggeration, undue emphasis, omission or in any
other way. Every effort should be made to avoid ambiguity.
Absolute or all-embracing claims should be used with caution
and only with adequate qualification and substantiation.
Descriptions such as “safe” and “no side effects” should
generally be avoided and should always be adequately qualified.
Drug Information Association www.diahome.org 6

7. Substantiation
Promotion should be capable of substantiation either by
reference to the approved labeling or by scientific evidence.
Such evidence should be made available on request to
healthcare professionals. Companies should deal
objectively with requests for information made in good faith
and should provide data which are appropriate to the
source of the inquiry.
Drug Information Association www.diahome.org 7

8. The Challenge

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-mobile
Drug Information Association
Print Otherwww.diahome.org 9

10. 38,000 pieces in 2000
79,000 pieces in 2010
1. Decrease in the number of sales
representatives pounding the pavement from
an all-time high of 100,000+ in 2006
2. Proliferation of new communications channels
3. Significant shift in the way that people prefer to
consume information.
Just hitting stride of social media
Drug Information Association www.diahome.org 10

11. Costs of promotional materials
Drug Information Association www.diahome.org 11

12. Drug Information Association www.diahome.org 12

13. Processes and costs related to
management of promotional
materials
Technology and resources that can
reduce time and cost of
promotional materials
management
Drug Informationwww.diahome.org
Association 13

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 al
Drug Information Association www.diahome.org 14

15. eCTD - Promotional Material Types
Document / Digital Asset Audio Promotional Labeling Regulatory
Management Book Radio
Marketing (internal)
Carrier Reply Card
½ Million Review Touch Points
Media Production Software
Carton Reprint Marketing (external)
Collaboration Catalog Sales Aid
CD-ROM Sales
100s
Promotional Slides
Workflow
Millions of Records
Claims Repository / Archive
Direct Mail
Drug Sample
Telephone Medical
TV
Exhibit Legal
10 1000s
Video News Release
eCTD Submission File Card
10s of Millions of External Exposures
Management Solution
Form Econ
Form Kit
Video
www-banner
Executive Management
Regulatory Information R&D
www-ecomm
Management Solution Giveaway
House Organ www-links Health Authorities
100s
Marketing and Sales www-other
Kit
Analytics Patients
Monograph www-soc-med
Website &Web Content Other www-website Prescribers
Management Press Release www-video
Print Ad www-mobile
Project Management
Print Other

16. Execution of process
Review Review
Review
Submit Create
eCTD or Media
Review
Approve
Medical
Review Review
Regulatory Marketing

17. Organizational structure
• Campaign Oriented Projects
– Product
– Market
– Release Date
– Media format

18. Technology to Optimize
Promotional Materials Management

19. How does technology help
Promotional 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 types
Drug Information Association www.diahome.org 19

20. Systems associated with Promotional Materials
Management (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
Solution
Drug Information Association www.diahome.org 20

21. Document Management Capabilities and
Requirements
• 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 Integrity
Drug Information Association www.diahome.org 21

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 material
Drug Information Association www.diahome.org 22

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. 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. • 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
• .vob
Drug Information Association www.diahome.org 25

26. Endpoints
Instance Instance
Upstream
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
Instance
Drug Information Association www.diahome.org 26

27. Dirk’s Contact Info
Dirk Karsten Beth | Chief Executive Officer | Mission3, Inc.
@dirkbeth
@regtrack
Group: Registration Tracking
www.mission3.com
dirk@mission3.com
Drug Information Association
27 www.diahome.org