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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
2 Copyright © 2014 Deloitte Development LLC. All rights reserved.2Deloitte
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)
3 Copyright © 2014 Deloitte Development LLC. All rights reserved.
Risks and OpportunitiesImpact of Integration
4 Copyright © 2014 Deloitte Development LLC. All rights reserved.
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
5 Copyright © 2014 Deloitte Development LLC. All rights reserved.
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
6 Copyright © 2014 Deloitte Development LLC. All rights reserved.6Deloitte
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
7 Copyright © 2014 Deloitte Development LLC. All rights reserved.
Leveraging QbD to drive submissions speed and quality
Quality by Design
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Regulatory’s RoleCross-functional engagement
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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
10 Copyright © 2014 Deloitte Development LLC. All rights reserved.
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
11 Copyright © 2014 Deloitte Development LLC. All rights reserved.
IntegrationIntegrating Regulatory Documentation across the Value Chain
12 Copyright © 2014 Deloitte Development LLC. All rights reserved.
Access to information is critical for stakeholders across the extended enterprise
Regulatory Handoffs – Functional Intersections
VisibilityVersioning
QualityComplianceSpeedSafety
13 Copyright © 2014 Deloitte Development LLC. All rights reserved.
Document management sits at the core of an effective RIM capability
The Regulatory Ecosystem – Cross-functional, Global, Complex
14
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accounting.
Copyright © 2013 Deloitte Development LLC. All rights reserved.
Member of Deloitte Touche Tohmatsu Limited