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


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


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Challenges

Incomplete processes and technology

Lack of compliance

New communications

channelsCosts

Collaboration

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The Office of Prescription Drug Promotion (OPDP)

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• "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

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090142.htm

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090142.htm

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Compliance

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www.mission3.comhttp://pharmamkting.blogspot.com/2012_11_01_archive.html

http://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.

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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

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+1 602 957 2150


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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

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Begin With the End in Mind

Planning Review and Approval

2253 and/or

FinalizationSubmission Archival Metrics and

Reporting

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Review

Review

Review

Execution of process

Create

ReviewMedical

ReviewLegal

ReviewRegulatory

Approve

Submit eCTD or Media

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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

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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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What’s Coming and When?

2014

Module 1 Implementation

2016

Mandatory eCTD Marketing Applications

2017

Mandatory eCTD INDs

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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

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Updated Module 1

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Granularity

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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


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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)

+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

+1 602 957 2150


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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

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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 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

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• System should have predefined search / reporting capabilities– Impact of label change– Slice and dice of

• Campaigns • Materials• Usage• Issues• Reviews / Approvals

Automatic Surveillance

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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


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DIA 29

Adair Turner Director of Clinical and Regulatory Operations

2198 E. Camelback Rd.Phoenix, AZ 85016

[email protected] x1004 office

Mission3 electronic Promotional Materials Management (eMPM) Webinar April, 23 2014

Health & Medicine

camelback rd

regulatory review

fda form

form fda

example social media

mind planning review

regulatory compliance

social media outlets