Significant change is underway in Regulatory Affairs as life science companies re-evaluate their global operating capabilities in light of today's data-driven standards and newly available technologies. Mounting pressure to operate more efficiently worldwide is driving companies to optimize and harmonize processes, improve data usage and management, and adopt shared global systems. In this presentation, Cary Smithson will discuss potential ways to leverage the latest technologies to address today's business challenges in Regulatory and provide a practical approach for driving transformation and enabling greater efficiency.

1. February 5-7 | Bethesda North Marriott
Hotel and Conference Center
Regulatory Submissions, Information,
and Document Management Forum
Achieving Digital Transformation in
Regulatory
Cary Smithson
Principal Consultant
OpenText Life Sciences Professional Services
csmithso@opentext.com

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Disclaimer
Page 2

3. Agenda
Current challenges in Regulatory
Leveraging technology to address these
challenges
A practical approach for driving transformation
and greater efficiency
Conclusions / Q&A
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4. “Why don’t these systems talk to each other?”
“Who has the master version of the tracking spreadsheet?”
“There has got to be a more efficient way to manage our
submissions and registrations!”
© 2018 DIA, Inc. All rights reserved.
Is this familiar?
Page 4
“How can I get the data I need to
produce a report on the quality of
our submissions?”
“I can’t believe we still use email to
collaborate with CROs and
partners!”
“And now we need to comply
additional data standards (e.g.,
SPOR, UUID, PQ/CMC)?!”
“The technology I use at home
works so much better than at work!”

5. From To
Multiple, stand-alone systems and
fragmented, inefficient business
processes
End-to-end, integrated systems and
streamlined, optimized processes
Not knowing where data is or not
having the correct data
Well-governed data, defined sources
of record and established metrics
Tracking spreadsheets Capturing key data as part of the
process
Manual reporting efforts Automated report generation and
user-friendly analytics capabilities
Lack of visibility Data and process transparency and
predictive analytics
Collaboration via email Collaboration integrated into business
processes
© 2018 DIA, Inc. All rights reserved.
Addressing Regulatory Challenges
Page 5

6. Systems of
Engagement
Artificial
Intelligence
Analytics
Master Data
Management
Cloud and
Others
Enabling the Business with Technology

7. What it is:
• An intuitive user experience on top of existing systems
– an abstraction layer
• Quick to adapt to process change
• Includes mobile and social capabilities
Example uses:
• CMC Change Management across content
management, RIM, QMS and manufacturing systems
• Regulatory Intelligence to evaluate new regulations
and manage follow-up actions across RIM, analytics
and content management
© 2018 DIA, Inc. All rights reserved.
Systems of Engagement
Page 7

8. © 2018 DIA, Inc. All rights reserved.
Sample Uses for Artificial Intelligence
Page 8
• Further automate
document classification
and simplify search with
natural language
processing
• Quality checking of
submission document
formats
• Handle initial submissions

9. © 2018 DIA, Inc. All rights reserved.
Master Data Management
Page 9
Core of business
process
Define sources of
record
Implement a data
governance model
Plan for continuous
data
Key action after
mergers &
acquisitions

10. • Extract IDMP and other
data from unstructured
documents
• Understand and act on:
• Global regulatory intelligence
& submission requirements
• Business process metrics to
drive greater efficiency and
quality
• E.g., trends in agency
inquiries to improve
submission quality
• Product safety signals
Uses for Analytics

11. Move to cloud-based
systems over time
Key Benefits
• Lower cost
• Disaster recovery
• Simpler software updates
• Capital-expenditure free
Other technologies (e.g.,
Blockchain)
© 2018 DIA, Inc. All rights reserved.
Cloud, etc.
Page 11

12. Assess
Current
State
Envision
Future
State
Analyze
Gaps
Establish
Priorities
Develop
Roadmap
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Driving Regulatory Transformation
Page 12
The following high-level approach help you understand your challenges in
Regulatory and develop a plan for addressing them and transforming your
business

13. Assess
Current
State
Envision
Future
State
Analyze
Gaps
Establish
Priorities
Develop
Roadmap
© 2018 DIA, Inc. All rights reserved.
Assess Current State
Page 13
• Define the scope and goals for your
analysis
• Gather information on the current state
of people, process, technology and data
in Regulatory
• Seek to understand where you have the
biggest pain points
• Watch out for analysis paralysis! Time
box this!
Current
State
People
Process
Tech
Data

14. Example Current Regulatory Process
Plan
Assembly
Author and
Approve
Documents
Assemble
Submission
Publish and
Submit
Store and
View
Track and
Manage
•Create
document
outline for
upcoming
submission
• New Approvals
(NDA, MAA)
• Recurring (Periodic
and Safety Reports
• Change
(Amendments and
Variations)
•Create, review,
and approve
documents to
be included in
submission
• Cross functional
documentation
(Nonclinical,
Clinical, Quality,
and Regulatory)
• Highly structured
content based on
guidance
regulations
•Assign
documents to
submission
outline
•Create XML
based Table of
Contents based
on regional
guidances
required by
health
authorities
•Encrypt PDFs
• Assemble PDFs for
Paper output
•Submit to
agency
•Save submitted
version for
record keeping
•Search for and
navigate
archived
submission
•Save and
manage
correspondence
•Track approvals
from regional
health authority
•Conduct impact
assessment
and manage
submissions for
changes
Spreadsheets
Manually in
Publishing Publishing
Spreadsheets
or Reg Tracking
DMS File Share
…and a separate set of systems and manual processes are typical for
Regulatory Intelligence

15. Assess
Current
State
Envision
Future
State
Analyze
Gaps
Establish
Priorities
Develop
Roadmap
© 2018 DIA, Inc. All rights reserved.
Envision Future State
Page 15
• Define a future vision for
Regulatory
• What are leading firms doing?
• What are other industries doing?
• What capabilities are needed to
support the business?
Future
State
People
Process
Tech
Data

16. A Sample Future Vision for Regulatory
Simplify the user experience by supporting end-to-end business flows
Intuitive,role-basedsystemwithworkflow
DataStorage
Regulatory
Intelligence
Regulatory
Strategy &
Planning
Submission
Planning &
Management
Authoring
Publishing,
Submitting &
Archival
Standards
Compliance
(e.g., SPOR,
XEVMPD)
Registration
Management
Management of
CMC Changes
Correspondence
& Commitment
Management
Data
Management &
Analytics
Artificial
Intelligence
Content
Management &
Archiving
Regulatory
User
Technical Capabilities
Business Capabilities

17. Assess
Current
State
Envision
Future
State
Analyze
Gaps
Establish
Priorities
Develop
Roadmap
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Analyze Gaps
Page 17
• How does the current state
compare with your vision?
• What gaps need to be closed?
• What initiatives do you need to
execute to achieve the vision?
Future
State
Current
State
GAPS
Initiatives
and Projects

18. Assess
Current
State
Envision
Future
State
Analyze
Gaps
Establish
Priorities
Develop
Roadmap
© 2018 DIA, Inc. All rights reserved.
Establish Priorities
Page 18
• Which gaps should you close first?
• Any quick wins?
• Where do you get the greatest business
benefits?
• Is there a logical order to the initiatives
you have defined?
Prioritized Initiatives and Projects
1
2
3
4

19. Assess
Current
State
Envision
Future
State
Analyze
Gaps
Establish
Priorities
Develop
Roadmap
© 2018 DIA, Inc. All rights reserved.
Develop Roadmap
Page 19
• Up to 3 year time horizon
• Lay-out prioritized initiatives to
achieve your future vision
• Include business change
management in your plans

20. Experiment with innovative ways to leverage
technology to optimize Regulatory processes
Focus on the process and user experience
Defining and governing your master data is
essential
A solid strategy and roadmap definition
approach is key to transforming your business
Don’t forget about business change
management
Conclusions