RIM - Roundtable Presentations - 2016 · RIM - Roundtable Presentations - 2016 Created Date:...

© Copyright 2016 Veeva Systems Inc., all rights reserved veeva.com |

Transforming Regulatory Processes


Transforming Regulatory Processes: What Needs to Change and How to Do It

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Jim ReillyDirector, Product StrategyVault RegulatoryVeeva Systems


The Need to Change§ Regulatory is at the tip of the spear of realizing market potential and getting therapies to patients

§ Opportunity to enhance our operations through:§ Process Adjustments§ Technology Centralization§ Data Consistency§ Focus on Operational Learning

§ With adjustments, we can realize the vision of working smarter, not harder

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© Copyright 2016 Veeva Systems Inc., all rights reserved veeva.com | 4

Biggest Pain Points

Average efficiency of integrated RIM processes

9% 6%Average efficiency of manufacturing

change control processes

Source: Steve Gens & Associates, Winter Edition, 2015.


Processes and Systems are Misaligned

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Ø Process made complex by technologyØ Redundancy of information

Ø Limited connectivity of informationØ Difficult to report on progress


Common Challenge: No Standardization or Tracking

Lack of Standardization

No Central Tracking

§ Multiple systems § Multiple spreadsheets§ No consistency across systems or spreadsheets

§ No consistent terminology or dictionary

§ No consistency of what to capture§ No consistent ownership

Lack of Traceability

Lack of Metrics

§ No holistic view§ No connections between documents and data

§ No ability to assess impact

§ Can’t aggregate or compare across products or regions

§ No input to process improvements

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The Result: Data Black Hole

Lack of Visibility• No data summarization or reporting

Communication Breakdowns• Lack of regional info sharing• Status/Progress not shared


Common Challenge: Manual Processes

No automation / facilitation• No alerts, parallel reviews, auto-updates on state change

Reliance on email and calls• Information black hole

Manual plans• Struggle to keep current

Single point of contact• Human foibles, e.g. delays when passing along correspondence


Ideal State: A Holistic View with Clear Connections

Application Chronology for Restolar IND 0123456


Ideal State: Automation to Minimize Errors and Effort


Alert@


How does it look at your company?

What would you like to change?

A pause for discussion…


How Do We Get There?

Laying a Foundation

Getting Started

Advanced Capabilities

• Roles & responsibilities• Common definitions• Common systems

• Working in a system• Clean consistent data• Automation

• Reporting• Metrics• Traceability

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Lay the foundation: Roles & Responsibilities

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Owner

Project Manager

Contributors

Partners


Lay the Foundation: Common Definitions

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What constitutes a commitment?

What gets tracked?

Who manages which type?

What gets reported on?


Lay the Foundation: Common Systems

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Headquarters

Affiliates

External parties

Other departmentsGlobal/central use of

systems


Getting Started: Work Within a System

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Internally Driven Change

Externally Driven Change

New ApplicationAnnual reportLabel changeShelf life extension

• Create regulatory events

• Define related activities• Assign ownership

• Plan submissions• Develop deliverables

• Track due dates• Link to HA correspondence

• Finalize submissions• Report

Additional information requestIncremental study requestManufacturer problems


!

Getting Started: Automation

Calendaring Workflows Notifications

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Getting Started: Prioritize Clean and Consistent Data

Centralize or standardize data entry

Establish a governance process for dictionary management

Designate data owners responsible for quality

Usage of a standardized dictionary

• Product Information• Application• Submission

• Study Information• Manufacturer(s)• Vocabularies

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Advanced Capabilities: Reporting

Report across related elements for global registration insights

Allocate work to local teams and track

activities

Global Registration Status

Local Market Activities

Which are open, closed, have due date

approaching

Track within and across applications

CommitmentsCorrespondence

Capture expected activities, submissions, and commitments

Calendar

Content PlanProgress

Deliverable Status

Submissions

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Advanced Capabilities: MetricsDocument Status

Clinical Non Clinical Quality Regulatory

Record Count

Days until Planned Submission

Documents Approved This Month

192 days

23 documents

Overdue Approval Tasks Average Time to Approval

• Receipt dates• Due dates• Time to respond• Plan vs. actual• Region or area• Response targets


Advanced Capabilities: Traceability

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Creating relationships enables you to trace the impact of business changes.

PRODUCT

REGISTRATION

SUBMISSION(S)

APPLICATION(S)

CORRESPONDENCE

COMMITMENT(S)

EVENT(S)

CHANGE REQUESTS

ACTIVITIESDOCUMENT(S)

A Manufacturing Process Changed: Now What?


Thank You

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Wrap-up


A Long List of What’s Wrong

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Lack of standardizationLack of automationLack of central trackingLack of automated trackingLack of traceabilityLack of metricsLack of visibilityLack of communication


Ideal State: A Holistic View with Automation


Alert@

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Solution

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§ Approach Pharma with a manufacturing discipline§ Approach Reg Ops as a critical path activity, strategically

§ Address core Reg Ops document-centric processes to shorten time to market and improve quality


The Power of Metadata

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Enabling Search & Filters

Driving content plans

Auto-Naming

Driving Reporting


Have Process and Technology Sing

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BINDERS TEMPLATES & DOCUMENT TEMPLATES

BINDER STRUCTURE& METADATA

PLANNED DOCUMENTS

VIEWABLE RENDITIONS

BINDER EXPORT FOR SUBMISSION VENDOR

Content Planning

Templates / Documents Initialized

Content Authoring and Review

Final Formatting (Limited)

Publishing, QC &

DispatchArchiveContent

Approval

RAPID ENHANCED CHECK OUT / IN VIA SUBMISSION BINDER*


How Do We Get There?

Laying a Foundation

Getting Started

Advanced Capabilities

• Roles & responsibilities• Common definitions• Common systems

• Working in a system• Clean consistent data• Automation

• Reporting• Metrics• Traceability

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Thank You

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RIM - Roundtable Presentations - 2016 · RIM - Roundtable Presentations - 2016 Created Date:...

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