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Mastering Regulatory Information

Integrating Content Management Across the Enterprise

Veeva R&D Global Summit

Deloitte Consulting LLP

October 21, 2014

1 Copyright © 2014 Deloitte Development LLC. All rights reserved.

The Evolving Life Sciences LandscapeEmerging models and industry trends

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Industry trends

• Many companies moving to SaaS/cloud

• Emerging governance models to validate cloud solutions

• Increasing breadth, complexity of regulatory requirements

• Communication among health authorities

• Expectations for global control and transparency

• Innovation is stifled by traditionally poor knowledge-sharing and access to

thought leadership within a company

• Interest around industry collaboration to design future shared tools

• Significant M&A activity in life sciences

• Multiple companies have split company operations along product lines

Cloud platforms are supporting trends in regulatory oversight and global partnerships

Regulatory

Challenges

SaaS / Cloud

Innovation &

Collaboration

Structural Change

(e.g. M&A, Splits)


Risks and OpportunitiesImpact of Integration


Ineffective document control can be a significant factor in compliance and quality-related costs

“The real cost of poor quality is often hidden

but can be as much as 15-25% of total costs”

Case Studies: Costs of Poor Quality

Juran Institute, ‘Tip of the Iceberg’, May 2001

Rework

• Product Recall

Incorrect versioning, poor document management and lack of visibility lead to a pan-Asia product recall

• Withdrawal from Market

One company’s inability to locate documentation led to over $1 Million in consulting costs and eventual forced withdrawal of the product


Effective document management provides opportunities to streamline submissions and increase submissions quality

Case Studies: Opportunities

• Speed to Market – Streamlined Submission

Integrating knowledge management and effective use of templates contributed to reduction of submissions development times

• Speed to Market – Data Quality

The technical quality of the submission can have a direct impact on review times

NDA Approvals:

Avg. Review

Time(Months)

20 101517 1112

121418

16

16

One Company’s US Product Approvals (2007-2012)Average NDA Review Times

All NDA Approvals 16.4 Months

Approvals without CRL 9.4 months

Approvals with CRLs 35 months

Global submissions: First market to last

90 Days 9 Years

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Performance Drivers

• Global repository provides opportunities for leveraging leading practice

• Global submissions is input for Regulatory Intelligence

• Reuse of content from source documentation such as the TMF to speed

submissions development

• Global access to validated documents for market-to-market consistency

• Document templates drive consistency, enforce content expectations

• Templates reduce the need for rework, including reformatting

• Enterprise taxonomy / control vocabulary improves search quality

• Supports linking to broad-based RIM solutions

Effective document management can have measureable impact on performance

Content Reuse

Knowledge

Sharing

Templates

Master Data

Management

• Enterprise approach to submissions metrics drives compliance

• Performance measures allow early detection of issues, bottlenecks

Performance

Measurement


Leveraging QbD to drive submissions speed and quality

Quality by Design


Regulatory’s RoleCross-functional engagement


Meetings

Q&A KM

Inspections

Planning &

Tracking

Content

Development

Registration

Management

Po

rtfo

lio

Publishing

& Submission

Review

Period Q&A

Variations &

Supplements

Change

Assessments

& Filing

Submissions

Commitments

Inspections

Periodic Reports

Authoring

Assembly

Dossier

Review &

Approval

Translations

Contributors

Safety

CMC

Clinical

Non-

Clinical

External

Stakeholders

Affiliates &

Distributors

Health

Authorities

Partners

Local Updates

Translations

Archiving

Renewals

Registries

Periodic Reporting

Assessment

Filing

Notification

Knowledge Management supports the entire RIM lifecycle, leveraging data, documents, metrics and experience

Indications

Changes

Regulatory drives or supports key processes throughout the product lifecycle

Ap

pro

va

l

Internal Stakeholders

Supply

ChainQuality

Labeling

Q

Safety


Content Management is Core to Labeling Management and Compliance

Labeling processes center around content development, review, approval and deployment.Leading companies leverage global access to current, official content

to drive quality, efficiency, and CCDS compliance


IntegrationIntegrating Regulatory Documentation across the Value Chain


Access to information is critical for stakeholders across the extended enterprise

Regulatory Handoffs – Functional Intersections

VisibilityVersioning

QualityComplianceSpeedSafety


Document management sits at the core of an effective RIM capability

The Regulatory Ecosystem – Cross-functional, Global, Complex

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