This document discusses promotional materials for pharmaceutical companies. It begins with definitions of promotional materials and promotion, noting that promotion aims to promote prescription and use of pharmaceutical products. It emphasizes that promotional information must be accurate, balanced, and not misleading, and any claims must be substantiated. Finally, it discusses the large number and types of promotional materials companies must manage, and the processes, costs, and technologies involved in managing and reviewing all these materials to ensure they meet compliance standards.
Presented by Antoinette Azevedo, e-SubmissionsSolutions.com at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
Life sciences regulatory authorities in North America, Europe and Japan have been developing standards for drug and biologic registration submissions in electronic format for over ten years. The current version of the format—electronic Common Technical Document (eCTD)—has been the recommended format since 2005 and is on the way to becoming mandatory. This presentation will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review.
A California biotech submitted an eCTD to the US FDA in summer 2005. This company used commercial-off-the-shelf publishing software, experienced consultants, and in-house staff to compile this eCTD. This drug was the biotechs first candidate for commercialization. The biotech was partnered with big Pharma to assist with sales and marketing after the FDA authorized the drug for marketing. The biotech hired a sales force of nearly 200 in anticipation of FDA approval.
The FDA issued a refuse-to-file on this eCTD in fall 2005, due to problems with the PDF files and navigability of the content of the submission. The company’s market capitalization dropped 50% overnight. The company had to recompile the submission, by reworking the source files and rebuilding the XML backbone. The new version of the eCTD was resubmitted in early 2006. The FDA accepted the resubmission for review.
However, in May 2006 the FDA issued an approvable letter, that meant the drug could be approved in the future if certain conditions were met (meaning yet another delay in being able to market the product, plus additional expense to conduct further clinical studies). In June, 2006, the big pharma company terminated the partnership with the biotech. In July 2006, the biotech laid off their sales force. In August, 2006, the biotech laid off 100 more employees. In September 2006, the biotech had a meeting with FDA to discuss what additional studies and analysis was needed. Finally, in January 2007, the biotech announced plans to resubmit its NDA by end of second quarter 2007.
This presentation will describe:
* Regulatory and business drivers behind the eCTD format
* Technical components of an eCTD
* Practical implications of collecting documents and data over the discovery, development, application review, and post-marketing lifecycle phases of a drug or biological product
* Global picture for adoption of the eCTD format
* Future direction for the eCTD format
* Role of electronic document management in the eCTD lifecycle
* Top 12 Issues FDA Has with eCTD and how to avoid them
* Preparing submission-ready source documents and data for submission in eCTD
* Whether to purchase an eCTD publishing system or to outsource.
* How to prepare for the technical challenges of eCTD
ISO IDMP: Practical considerations from XEVMPD experienceQdossier B.V.
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabularies
Presented by Antoinette Azevedo, e-SubmissionsSolutions.com at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
Life sciences regulatory authorities in North America, Europe and Japan have been developing standards for drug and biologic registration submissions in electronic format for over ten years. The current version of the format—electronic Common Technical Document (eCTD)—has been the recommended format since 2005 and is on the way to becoming mandatory. This presentation will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review.
A California biotech submitted an eCTD to the US FDA in summer 2005. This company used commercial-off-the-shelf publishing software, experienced consultants, and in-house staff to compile this eCTD. This drug was the biotechs first candidate for commercialization. The biotech was partnered with big Pharma to assist with sales and marketing after the FDA authorized the drug for marketing. The biotech hired a sales force of nearly 200 in anticipation of FDA approval.
The FDA issued a refuse-to-file on this eCTD in fall 2005, due to problems with the PDF files and navigability of the content of the submission. The company’s market capitalization dropped 50% overnight. The company had to recompile the submission, by reworking the source files and rebuilding the XML backbone. The new version of the eCTD was resubmitted in early 2006. The FDA accepted the resubmission for review.
However, in May 2006 the FDA issued an approvable letter, that meant the drug could be approved in the future if certain conditions were met (meaning yet another delay in being able to market the product, plus additional expense to conduct further clinical studies). In June, 2006, the big pharma company terminated the partnership with the biotech. In July 2006, the biotech laid off their sales force. In August, 2006, the biotech laid off 100 more employees. In September 2006, the biotech had a meeting with FDA to discuss what additional studies and analysis was needed. Finally, in January 2007, the biotech announced plans to resubmit its NDA by end of second quarter 2007.
This presentation will describe:
* Regulatory and business drivers behind the eCTD format
* Technical components of an eCTD
* Practical implications of collecting documents and data over the discovery, development, application review, and post-marketing lifecycle phases of a drug or biological product
* Global picture for adoption of the eCTD format
* Future direction for the eCTD format
* Role of electronic document management in the eCTD lifecycle
* Top 12 Issues FDA Has with eCTD and how to avoid them
* Preparing submission-ready source documents and data for submission in eCTD
* Whether to purchase an eCTD publishing system or to outsource.
* How to prepare for the technical challenges of eCTD
ISO IDMP: Practical considerations from XEVMPD experienceQdossier B.V.
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabularies
DRA (Drug Regulatory Affairs) , RA (Regulatory Affairs)Naman Ruhela
A Brief Introduction about the Regulatory Affairs / Drug Regulatory Affairs (DRA). Introduction to Drug Regulatory Affairs. Why Drug Regulatory Affairs?. Role of Regulatory Affairs Experts. Types of the company hiring RA professionals. RA professional can get employment. Regulatory Bodies.
The introduction of Identification of Medicinal Products (IDMP), as developed by the International Organization for Standardization (ISO), marks the next phase of evolution for the European drug dictionary project under Article 57.
The European Medicines Agency (EMA) will issue guidance based on five documents published by the ISO, which will require life sciences companies to use a "set of common global standards for data elements, formats, and terminologies for the unique identification and exchange of information on medicines."
Complying with IDMP represents a massive increase in scope and complexity, in addition to previous iterations. The EMA has divided the timeline for meeting the new requirements into several phases, making this a multi-year project.
Perficient’s expert in IDMP and the EudraVigilance Medicinal Product Dictionary, Mark Thackstone, reviewed everything you need to know in order to successfully comply with IDMP by the fast-approaching deadline:
-Latest information and timelines
-Steps to take meet regulatory requirements
-Challenges and factors to consider
-What IDMP means in the real world of a typical pharma company
Advantages of Pharma in India, Market Share and Economic Drivers, Structure of Pharma Sector, Evolution of Pharma, Revenue %, Market Share, Porter 5 Force Model, BCG Matrix, Government Policies, Opportunities.
The IDMP Challenge - Whitepaper on ISO IDMP by CunesoftV E R A
The updated whitepaper on ISO IDMP - learn what you need to know during this transition. And how Cunesoft's cune-IDMP can help your organization: https://cunesoft.com/en/products/idmp/
This generally deals with ANDA litigation in United states with Paragraph iv litigation generally. It also emphasizes on Cost involved in ANDA litigation with different methods for reducing the cost.and how many million or billion at stake when Generic and Branded drugs. It also covers the litigation part of District New Jersey that how and in what manner litigation with respect to Hatch-waxman act an is done along with the timelines and CAFC timelines.
The coming era of digital therapeutics nrc live - sept 2018Chris Hogg
Thoughts on the past, present and future of digital therapeutics and digital medicines. Presentation for NRC Live Zorgtech Conference in Amsterdam, September 2018.
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
Spread over more than 1,05,000 sq. ft. area, Cadila Pharmaceuticals’ R & D facilities, recognized by the Department of Science & Technology, Government of India, are manned by more than 300 scientists. A centralized Quality Control & Analytical Research Laboratory has been set up to meet the domestic and international quality standards. The Company has expanded operations by building further on already existing set-up by investing in new premises, to include modern, state-of-the-art amenities. One of the few companies in the country carrying out collaborative research, Cadila Pharmaceuticals taps the best scientific talent in the country and has collaborations with more than 30 leading Research and Development centers in India.
To know more about Cadila Pharmaceuticals visit: http://cadilapharma.com/
How Oracle Argus Safety 8.x Supports Product Safety NeedsPerficient, Inc.
Pharmaceutical, biotechnology, medical device, and contract research organizations (CROs) have many reasons to use a safety and pharmacovigilance system, such as Oracle's Argus Safety. From capturing adverse events and product complaints to reporting individual case safety reports (ICSRs) to regulatory authorities, a comprehensive solution can address most needs.
In our webinar, Perficient’s Dr. Rodney Lemery, Director of Safety and Pharmacovigilance, reviewed the newest release of Argus Safety. This presentation demonstrated both the basic and complex needs of life sciences companies that can be supported through the implementation or upgrade of the system.
DRA (Drug Regulatory Affairs) , RA (Regulatory Affairs)Naman Ruhela
A Brief Introduction about the Regulatory Affairs / Drug Regulatory Affairs (DRA). Introduction to Drug Regulatory Affairs. Why Drug Regulatory Affairs?. Role of Regulatory Affairs Experts. Types of the company hiring RA professionals. RA professional can get employment. Regulatory Bodies.
The introduction of Identification of Medicinal Products (IDMP), as developed by the International Organization for Standardization (ISO), marks the next phase of evolution for the European drug dictionary project under Article 57.
The European Medicines Agency (EMA) will issue guidance based on five documents published by the ISO, which will require life sciences companies to use a "set of common global standards for data elements, formats, and terminologies for the unique identification and exchange of information on medicines."
Complying with IDMP represents a massive increase in scope and complexity, in addition to previous iterations. The EMA has divided the timeline for meeting the new requirements into several phases, making this a multi-year project.
Perficient’s expert in IDMP and the EudraVigilance Medicinal Product Dictionary, Mark Thackstone, reviewed everything you need to know in order to successfully comply with IDMP by the fast-approaching deadline:
-Latest information and timelines
-Steps to take meet regulatory requirements
-Challenges and factors to consider
-What IDMP means in the real world of a typical pharma company
Advantages of Pharma in India, Market Share and Economic Drivers, Structure of Pharma Sector, Evolution of Pharma, Revenue %, Market Share, Porter 5 Force Model, BCG Matrix, Government Policies, Opportunities.
The IDMP Challenge - Whitepaper on ISO IDMP by CunesoftV E R A
The updated whitepaper on ISO IDMP - learn what you need to know during this transition. And how Cunesoft's cune-IDMP can help your organization: https://cunesoft.com/en/products/idmp/
This generally deals with ANDA litigation in United states with Paragraph iv litigation generally. It also emphasizes on Cost involved in ANDA litigation with different methods for reducing the cost.and how many million or billion at stake when Generic and Branded drugs. It also covers the litigation part of District New Jersey that how and in what manner litigation with respect to Hatch-waxman act an is done along with the timelines and CAFC timelines.
The coming era of digital therapeutics nrc live - sept 2018Chris Hogg
Thoughts on the past, present and future of digital therapeutics and digital medicines. Presentation for NRC Live Zorgtech Conference in Amsterdam, September 2018.
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
Spread over more than 1,05,000 sq. ft. area, Cadila Pharmaceuticals’ R & D facilities, recognized by the Department of Science & Technology, Government of India, are manned by more than 300 scientists. A centralized Quality Control & Analytical Research Laboratory has been set up to meet the domestic and international quality standards. The Company has expanded operations by building further on already existing set-up by investing in new premises, to include modern, state-of-the-art amenities. One of the few companies in the country carrying out collaborative research, Cadila Pharmaceuticals taps the best scientific talent in the country and has collaborations with more than 30 leading Research and Development centers in India.
To know more about Cadila Pharmaceuticals visit: http://cadilapharma.com/
How Oracle Argus Safety 8.x Supports Product Safety NeedsPerficient, Inc.
Pharmaceutical, biotechnology, medical device, and contract research organizations (CROs) have many reasons to use a safety and pharmacovigilance system, such as Oracle's Argus Safety. From capturing adverse events and product complaints to reporting individual case safety reports (ICSRs) to regulatory authorities, a comprehensive solution can address most needs.
In our webinar, Perficient’s Dr. Rodney Lemery, Director of Safety and Pharmacovigilance, reviewed the newest release of Argus Safety. This presentation demonstrated both the basic and complex needs of life sciences companies that can be supported through the implementation or upgrade of the system.
Clireo eTMF Solution by Arivis
What is Clireo?
• Comprehensive Software and Service enabling the Trial Master File
• Compliant with the DIA Trial Master File Reference Model Version 3
• Assign access and maintain control of Sites, Vendors, and Auditors for content.
• Eliminate CRA need to reconcile the Investigator Site File against the Sponsor TMF.
• Part 21 CFR 11 Digital signatures allow for faster turn around time on documents.
• Ability to quickly disseminate new information to users that the information is relevant to.
• Vendors and Sites can upload documentation and data directly into Clireo.
• Unlimited storage capacity assures that all documentation can be held in one location.
• No additional hardware required to implement.
• Dashboard reports on the status of sites and documents to easily identify missing or lagging information.
• Protect documents against unauthorized modification.
• Supports single or multiple file uploads with single screen metadata tagging.
• Centralized Documentation-Access from Anywhere.
• Resolve document issues faster.
• Ability to search documents in many ways.
• Dramatic Reduction in the need to print, scan, and store multiple copies in several locations.
• Link documents together to create a complete document package.
We have been serving eTMF customers since 2007.
Email now to schedule a demonstration and see how Clireo and Arivis can help you with your eTMF needs.
Tricia McQuarrie
Clinical Operations Manager tricia.mcquarrie@arivis.com
Arivis, Inc.
2198 E. Camelback Road
Phoenix, AZ 85016
Tel. 602-957-2150
www.m3.arivis.com
See the script for this presentation at this link:
http://www.slideshare.net/CommunicationCompliance/slide-notes-from-ccc-presentation-at-zinc-forum-prt-efficiency-turbocharging-commercial-and-compliance-effectiveness-sept-2013
Turacoz Skill Development Program tells you about the medico-marketing, its objectives, ethics followed, and the unethical marketing practices in the healthcare industry.
PhillyCooke eCTD Submissions for Ad-PromoDale Cooke
This presentation was initially delivered at the NJ/NY RAPS chapter on November 19, 2015. It reviews the FDA guidance on providing ad-promo submissions in electronic and print formats, explains the complex nature of the guidance and its scope, and includes the latest from FDA on how the guidance is being implemented.
The Other Agency: An introduction to Pharma MarketingDale Cooke
This presentation helps people understand FDA's regulation of the marketing and promotion of prescription products. Included are the most prominent regulations that promotion of prescription products must meet.
CRM Metrix presented: "IS SOCIAL MEDIA THE ALMIGHTY CONSUMER TOUCHPOINT?"
Where: Chicago WAW at the Hard Rock Chicago
When: June 9, 2010
Who: Hemen Patel
3.0 Project 2_ Developing My Brand Identity Kit.pptxtanyjahb
A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations.
CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
Personal Brand Statement:
As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
Recruiting in the Digital Age: A Social Media MasterclassLuanWise
In this masterclass, presented at the Global HR Summit on 5th June 2024, Luan Wise explored the essential features of social media platforms that support talent acquisition, including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok.
Top mailing list providers in the USA.pptxJeremyPeirce1
Discover the top mailing list providers in the USA, offering targeted lists, segmentation, and analytics to optimize your marketing campaigns and drive engagement.
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Vat Registration is a legal obligation for businesses meeting the threshold requirement, helping companies avoid fines and ramifications. Contact now!
https://viralsocialtrends.com/vat-registration-outlined-in-uae/
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An introduction to the cryptocurrency investment platform Binance Savings.Any kyc Account
Learn how to use Binance Savings to expand your bitcoin holdings. Discover how to maximize your earnings on one of the most reliable cryptocurrency exchange platforms, as well as how to earn interest on your cryptocurrency holdings and the various savings choices available.
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
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
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
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
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
Editor's Notes
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.