Mission3 electronic Promotional Materials Management (eMPM) Webinar April, 23 2014
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Transcript of Mission3 electronic Promotional Materials Management (eMPM) Webinar April, 23 2014
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Mission3 Promotional Materials Management
Adair Turner, MS, RACDirector of Clinical and Regulatory Operations
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, 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
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Challenges
Incomplete processes and technology
Lack of compliance
New communications
channelsCosts
Collaboration
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
The Office of Prescription Drug Promotion (OPDP)
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, 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/OfficeofMedicalProductsandTobacco/CDER/ucm090142.htm
OPDP Mission
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Compliance
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2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.comhttp://pharmamkting.blogspot.com/2012_11_01_archive.html
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Example – Social Media
• With the rapid increase of promotion through real-time social media outlets, pharmaceutical companies have wondered how to properly follow the regulations in the digital age.
• Promotions via tweet or Facebook post, for example, can be uploaded instantly, in large quantities, and, on Twitter at least, in a maximum 140 characters.
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Social Media Guidance Document Released
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
At the time of initial display, a firm should submit in its entirety all sites for which it is responsible on FDA Form 2253 or Form FDA 2301. For example, the firm should submit the comprehensive static product with the addition of the interactive or real-time components.
Once every month, a firm should submit an updated listing of all non-restricted sites for which it is responsible or in which it remains an active participant and that include interactive or real-time communications. Firms need not submit screenshots
Any subsequent changes should be annotated and resubmitted to the Agency on Form FDA 2253 or Form FDA 2301 at the time of initial display (i.e., resubmission).
= a LOT of submissions
Social Media Guidance Overview
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Benefits of a Cloud based system designed specifically for Life Sciences • Collaborate with your colleagues globally• Approve and disseminate information• Simple, efficient, and validation-ready• Easily configurable to support the varied Codes of
Practice in countries around the world• Provide access to key people, track versions and
repurpose assets across multiple channels• Search and find assets easily
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Begin With the End in Mind
Planning Review and Approval
2253 and/or
FinalizationSubmission Archival Metrics and
Reporting
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Review
Review
Review
Execution of process
Create
ReviewMedical
ReviewLegal
ReviewRegulatory
Approve
Submit eCTD or Media
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Endpoints
Released Source
Use locally
Instance Instance
Instance Instance
InstanceInstance
Instance
Use Locally
InstanceInstance
Instance
InstanceInstance
Instance
Use LocallyInstance Instance
Instance
Upstream• Review• Approval• Release
• Review• Approval• Release
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Technology Requirements• Regulatory submission capabilities• Track relevant metadata such as associated package
insert version date, dosage form, indication, supply classification, etc.
• Organize materials by campaign (launch, non-launch), claim, product, date, market (country/region), media format, etc.
• Create assets• Find assets easily• Report on expiration, usage, where used
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
What’s Coming and When?
2014
Module 1 Implementation
2016
Mandatory eCTD Marketing Applications
2017
Mandatory eCTD INDs
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Full eCTD and Non-eCTD submission support• New FDA Module 1 supports Promotional
Materials
4th Qtr. 2014
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Module 1 Update• Provide additional functionality
– Promotional submissions for CDER – Grouped Submissions
• Additional submission metadata to facilitate submission processing • Contact Information (e.g. regulatory, technical)• Submission Type – Submission ID• Submission Sub-Type – Sequence Number• Review and update M1 Headings and Hierarchy
– Major changes to 1.15 Promotional Material– Heading attributes for 1.1 Forms and 1.15
• Provide flexibility to reduce possibility of DTD changes – Attribute values (e.g. submission-type, submission-sub-type)
• Alignment with CDER/CBER business requirements and eCTD Version 4
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Updated Module 1
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Granularity
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2198 E. Camelback Rd #205Phoenix, AZ 85016
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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
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Promotional Materials
Document Management Media
Production Software
Collaboration
Workflow
Claims RepositoryeCTD
Submission Management
Solution
Regulatory Information
Management Solution
Marketing and Sales Analytics
Project Management
Website and Web Content Management
Systems associated with Promotional Materials Management (not necessarily discreet systems)
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Utilize Technology
Request materials Assign tasks Track against
milestones Assign resources
Workflow Review and comment
Track expected document due
dates
Report on expired assets
Link to eCTD System Submit to FDA
Track and Report on status of
claims and assets
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, 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
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Outside of the eCTD•Pieces must be developed to adequately
communicate to the reviewer•See all sides of a 3D piece•Be able to open video format•Provide links directly to reference materialeCTD submission capability• Latest US regional XML support (and support
within the interface)•Ability to support file types supported by the FDA
Submission Management Requirements
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, 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
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
Repo
sito
ryCo
nfigu
rati
on
eDMSElectronic Document
Management System
eTMFElectronic Trial
Master File
VDRVirtual Data
Room
Project Management - Import MS Project plans to populate the folder configuration.
SubmissionsRegulatory
Submissions
eMPMElectronic
Management of Promotional
Materials
Tool
sFe
atur
es Audit Trail Configurable System Admin
Single Sign-On(Claims-based authentication)
Full System Backup & Export
Multiple Security Levels
Cloud Storage
Bulk Upload Version Control (Check-in / out)
Workflow & Email Notifications
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
+1 602 957 2150
2198 E. Camelback Rd #205Phoenix, AZ 85016
www.mission3.com
DIA 29
Adair Turner Director of Clinical and Regulatory Operations
2198 E. Camelback Rd.Phoenix, AZ 85016
[email protected] x1004 office