This document provides information about Mission3 and their promotional materials management technology. It discusses challenges with current processes and compliance, and how their cloud-based system can help gain visibility, ensure claims are up to date, simplify reviews, and improve quality. Their technology includes capabilities like document management, media production, collaboration tools, and eCTD submission to help manage the promotional materials process.
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
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
Whether you've already implemented a clinical trial management system (CTMS) or are in the process of evaluating one, there are several commonly-requested system enhancements that can help streamline your team's operations.
Perficient’s Param Singh, director of clinical trial management solutions, discussed the top 5 CTMS enhancements requested by clients:
-Advanced investigational product tracking
-Electronic signatures on trip reports
-Protocol progress reports
-Protocol expenses
-Site selection
The webinar included a live demonstration of several enhancements.
Leveraging Your Security System to Impact Your Bottom lineguidepostsolutions
Guidepost Solutions, Nick Miller discusses “Leveraging your System to Operationalize your Business and Improve Processes to Impact Bottom Line” and is joined by Kurt Takahashi – AMAG, Andrew Campion – Comcast, Bret DuChateau – Northwest Mutual.
Mac McMillan on how to prepare your organization for an OCR HIPAA AuditIatric Systems
In this session, Mac McMillan provided several key takeaways that healthcare providers and vendors need to know before they receive an OCR audit letter.
Optimizing Product Realization Costs Across the Value ChainCognizant
Across a range of industries, realization of cost optimization requires a holistic approach throughout the product lifecycle - requirements, design, manufacture and post-launch - in order to weed out cost overruns and ensure the highest quality process and products.
Conflict Mineral Compliance Toolkit For Executives Matt Whitteker
Assent Compliance was the only software vendor that the SEC consulted with when passing the Conflict Minerals legislation. Assent has been on the ground floor and has been able to work with over 20% of S&P 500 companies in scope of the law. We've compiled this Ebook to assist with companies that need to comply. This is a play book with everything you need to know. If you want more information visit http://www.assentcompliance.com or email info@assentcompliance.com
Geographic diversification across different North American countries and the presence of major aircraft manufacturers, such as Bell Textron Inc., Joby Aviation, and Kitty Hawk, are the major factors driving the sales of eVTOL aircraft in North America.
There is a lot of competition seen among the key players of the structural health monitoring market. For instance, some of them are investing heavily into developing innovative products with improvising the existing technologies.
Increase Profits with Better Vehicle Listing DataConnotate
Auto dealers and providers of dealer support systems face big challenges obtaining vehicle listing data at an affordable price. Licensed data feeds are very expensive, and using internal IT resources to “do it yourself” creates operational headaches. Connotate’s Vehicle Listings webinar presents an innovative solution.
Best Practices for Implementing a Product Information Management (PIM) SystemNuxeo
This slide deck covers:
- Why “homegrown” systems and spreadsheets simply cannot serve as an effective PIM
- Winning use cases for PIM, by business function and industry, and how a PIM is critical for establishing a strong digital presence
- Key features and functionalities essential for a successful enterprise PIM application
Best Practices for Implementing a Product Information Management SystemMelinda Cormier
Improve productivity and time to market with an agile PIM solution. Organizations that share duplicate, “stale” or even obsolete product information with customers and partners inflict harm to their brand, incur hefty, needless costs and inevitably lose revenue. The most successful companies eliminate these risks by investing in product information management (PIM) technology and better product content publishing processes.
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
More Related Content
Similar to Mission3 electronic Promotional Materials Management (eMPM) Webinar April, 23 2014
Whether you've already implemented a clinical trial management system (CTMS) or are in the process of evaluating one, there are several commonly-requested system enhancements that can help streamline your team's operations.
Perficient’s Param Singh, director of clinical trial management solutions, discussed the top 5 CTMS enhancements requested by clients:
-Advanced investigational product tracking
-Electronic signatures on trip reports
-Protocol progress reports
-Protocol expenses
-Site selection
The webinar included a live demonstration of several enhancements.
Leveraging Your Security System to Impact Your Bottom lineguidepostsolutions
Guidepost Solutions, Nick Miller discusses “Leveraging your System to Operationalize your Business and Improve Processes to Impact Bottom Line” and is joined by Kurt Takahashi – AMAG, Andrew Campion – Comcast, Bret DuChateau – Northwest Mutual.
Mac McMillan on how to prepare your organization for an OCR HIPAA AuditIatric Systems
In this session, Mac McMillan provided several key takeaways that healthcare providers and vendors need to know before they receive an OCR audit letter.
Optimizing Product Realization Costs Across the Value ChainCognizant
Across a range of industries, realization of cost optimization requires a holistic approach throughout the product lifecycle - requirements, design, manufacture and post-launch - in order to weed out cost overruns and ensure the highest quality process and products.
Conflict Mineral Compliance Toolkit For Executives Matt Whitteker
Assent Compliance was the only software vendor that the SEC consulted with when passing the Conflict Minerals legislation. Assent has been on the ground floor and has been able to work with over 20% of S&P 500 companies in scope of the law. We've compiled this Ebook to assist with companies that need to comply. This is a play book with everything you need to know. If you want more information visit http://www.assentcompliance.com or email info@assentcompliance.com
Geographic diversification across different North American countries and the presence of major aircraft manufacturers, such as Bell Textron Inc., Joby Aviation, and Kitty Hawk, are the major factors driving the sales of eVTOL aircraft in North America.
There is a lot of competition seen among the key players of the structural health monitoring market. For instance, some of them are investing heavily into developing innovative products with improvising the existing technologies.
Increase Profits with Better Vehicle Listing DataConnotate
Auto dealers and providers of dealer support systems face big challenges obtaining vehicle listing data at an affordable price. Licensed data feeds are very expensive, and using internal IT resources to “do it yourself” creates operational headaches. Connotate’s Vehicle Listings webinar presents an innovative solution.
Best Practices for Implementing a Product Information Management (PIM) SystemNuxeo
This slide deck covers:
- Why “homegrown” systems and spreadsheets simply cannot serve as an effective PIM
- Winning use cases for PIM, by business function and industry, and how a PIM is critical for establishing a strong digital presence
- Key features and functionalities essential for a successful enterprise PIM application
Best Practices for Implementing a Product Information Management SystemMelinda Cormier
Improve productivity and time to market with an agile PIM solution. Organizations that share duplicate, “stale” or even obsolete product information with customers and partners inflict harm to their brand, incur hefty, needless costs and inevitably lose revenue. The most successful companies eliminate these risks by investing in product information management (PIM) technology and better product content publishing processes.
Similar to Mission3 electronic Promotional Materials Management (eMPM) Webinar April, 23 2014 (20)
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Best Ayurvedic medicine for Gas and IndigestionSwastikAyurveda
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
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The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
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Mission3 electronic Promotional Materials Management (eMPM) Webinar April, 23 2014
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. +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. +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. +1 602 957 2150
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The Office of Prescription Drug Promotion
(OPDP)
5. +1 602 957 2150
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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
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Compliance
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www.mission3.comhttp://pharmamkting.blogspot.com/2012_11_01_archive.html
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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. +1 602 957 2150
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Social Media Guidance Document Released
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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. +1 602 957 2150
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www.mission3.com
12. +1 602 957 2150
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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. +1 602 957 2150
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Begin With the End in Mind
Planning
Review and
Approval
2253
and/or
Finalization
Submission Archival
Metrics and
Reporting
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Review
Review
Review
Execution of process
Create
Review
Medical
Review
Legal
Review
Regulatory
Approve
Submit
eCTD or Media
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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. +1 602 957 2150
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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
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Full eCTD and Non-eCTD submission
support
• New FDA Module 1 supports Promotional
Materials
4th Qtr. 2014
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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. +1 602 957 2150
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Updated Module 1
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Granularity
22. +1 602 957 2150
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• 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. +1 602 957 2150
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Phoenix, AZ 85016
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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. +1 602 957 2150
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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. +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. +1 602 957 2150
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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. +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. +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. +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
Editor's Notes
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