In this presentation, we will be exploring how technology can be leveraged to improve submission readiness and the quality of your electronic submissions. Discover why planning submissions is important, and examine some of the key components of a successful submission readiness plan. Follow along via webinar format: https://info.montrium.com/webinar-automating-the-regulatory-submission-process

1. Automating the
Regulatory
Submission
Process:
Reducing Time &
Increasing Quality
1

2. 2
Agenda
LIVE WEBINAR
• Introduction to Montrium
• Keys to Submission Readiness Success
• Regulatory Submissions: Where we are today
• How Does Technology Empower Submissions
• Overview of RegDocs Connect

3. House Keeping
3A B O U T T H E C O M P A N Y

4. 4
House
Keeping
L I V E W E B I N A R
• This webinar is being recorded and
will be made available after this
session
• Feel free to use the chatbox to
submit your questions at anytime
• Q&A will take place at the end of the
webinar
• We will send these slides to your
email at the end of the webinar

5. • Montrium was founded in 2005
• Headquartered in Montreal, Canada
• EU HQ in Luxembourg
• Clients in North America, Europe & Asia
• Work exclusively in the Life Sciences Industry
• We have over 8000 Users in 20+ Countries
• Leading Content Management Platform
• Experienced Professional Services Group
5
About
Montrium
Connecting People,
Processes & Technology
A B O U T T H E C O M P A N Y

6. 6
Electronic Content
Management & Business
Intelligence for Clinical
Trials
C O N N E C T P L A T F O R M
Regulatory Document
Management & Submission
Planning for Drugs and
Devices
Integrated and Data Driven
Quality Management
Solutions for Life Sciences

7. 7
Meet Your
Speaker
Paul Fenton—
President and CEO,
Montrium

8. Regulatory Submissions
Where we are today
S E C T I O N # 1
8A B O U T T H E C O M P A N Y

9. 9
Overview
Submission Process & Key Intersections of Submission Readiness
Templates
Submission
Plan
Training Tracking
Task
Management
Integration
with eCTD
Communications
&
Correspondance

10. 10
Submission Readiness Challenges
• The regulatory landscape is complex
o Often requiring submission to multiple countries,
multiple times
• Content readiness is challenging
o Getting content in a submission ready format and
on time is still challenging
• The complications of managing resources
o Managing the many resources to produce the
content can be time consuming and complex.
• Version control is problematic
• Lack of system integration

11. 11
Submission Readiness Strategy
DEFINE
Formally defining the
complete submission
management process is key.
INTEGRATE
Make sure that external
stakeholders can access or
integrate with your
technology stack.
IDENTIFY
Identify how each step of the
process will be managed and
establish clear standards and
metrics.
TRAIN
Train (train and train) all
stakeholders on the process.
LEVERAGE
Leverage technology to help
manage the process from A-Z.

12. Submission Readiness
Key to success
S E C T I O N # 2
12A B O U T T H E C O M P A N Y

13. 13A B O U T T H E C O M P A N Y
eSubs Globally: Changes in Regulations
eSubs in US eSubs in EU
Beginning May 5, 2017
submission types NDA,
ANDA, BLA and
Master Files must be
submitted in eCTD
format
Commercial IND
submissions must be
submitted in eCTD
format beginning May
5, 2018
In centralized
procedure the EMA
now only accepts
submissions received
in eCTD format
Since March 2014, all
eCTD submissions
must be submitted
through eSubmission
Gateway

14. The Industry Today
0
20
40
60
80
100
120
2006 2015 2017
% of NDAs Submitted Electronically to FDA
Most companies are submitting electronically
RIM implementation is on the rise
Integrating all systems is the next priority
Systems are not necessarily integrated

15. Technology
Empowering the regulatory submission
process
S E C T I O N # 3
15A B O U T T H E C O M P A N Y

16. The Trinity of Systems
RIM
System
eCTD
Submission Building
System
Content
Management
System
Submission
Planning
Content Tracking
Communication
and Commitments
Submission
viewing
eCTD Builder
Sequence Publishing
Backbone generation
Submission through
gateway
Template Management
Metadata
Review Workflows
Authoring
Approval
Publishing
Storage and Archiving

17. 17
Impact of Integrated Technology: Before
Planning
Content
Creation Publishing Submission

18. 18
Impact of Integrated Technology: After
Planning
Content
Creation Publishing Submission

19. Leveraging Technology

20. • Submissions are (most) often time
critical
• Many stakeholders are often
involved
• Developing submission plans
electronically has significant
benefits
• Leveraging workflows to automate
collaboration around content is key
• Leveraging metrics to better plan
and communicate status provide
clarity
20A B O U T T H E C O M P A N Y
Submission
Planning
Why is
submission
planning
important

21. An Advanced Regulatory EDMS
and Submission Solution

22. Key Features
RegDocs Connect
Configurable & Intuitive
Workflows
Centralized Document
Collaboration
eCTD Mapping & Regulatory
Tracking Tools
PDF/A Rendering & Publishing
File Plan & Template Center
Compliant, Embedded
Digital Signatures

23. Planning Content
How to plan content with RegDocs Connect

27. Planning Content Benefits
What are the benefits of content planning?
Aligned with eCTD
Allows you to assign content to individuals with due dates across
applications and sequences
Assignable content
Provides clear status of each document contained within the plan
Clear status report
Initiates a workflow for each document to manage its lifecycle
Workflow creation
Allows you to easily assign existing content to new applications in different
regions
Content integration

28. Template Management
How to manage templates with RegDocs Connect

31. Permits the management of
template lifecycles
Can be integrated with metadata to
autofill templates
Allows you to publish ICH compliant
templates centrally
Ensures that authors are always
using the latest template
Template Management Benefits
What are the benefits of template management?
Improves overall quality of content and
reduces burden on Regulatory
Operations

34. Authoring & Review Benefits
What are the benefits of authoring and reviewing?
Automated Review
Automates the review process through
system generated tasks
Avoids Trackers & Nestled Folders
Avoids using trackers and nestled folder
structures to manage versions
Collaborative Authoring
Allows for collaborative authoring on
single document in real-time
Reduced Review Time
Significantly reduces review time through
parallel review cycles
Provides for a Review Hierarchy
Facilitated Review Tracking
Facilitates review tracking and multiple
rounds of review
Maintains Version History

35. Automated Publishing
How to auto-publish with RegDocs Connect

37. Automated Publishing Benefits
What are the benefits of automated publishing?
Allows regulatory operations to
focus on more critical tasks
Ensures that underlying source
document is always up to date
Ensures that proper format is
generated (PDF/A)
Automates many regulatory
publishing tasks

38. Electronic Approval
How to approve electronically with RegDocs Connect

40. Electronic Approval Benefits
What are the benefits of electronic approval?
Eliminates need for paper
copies & scans
Embeds signatures
directly in documents
Provides for audit trail directly
in document
Controls sequence of approval

41. eCTD Mapping & Integration
eCTD mapping & integration with RegDocs Connect

43. eCTD Mapping & Integration Benefits
What are the benefits of electronic approval?
Easy to see content of a particular type or from a
particular section across applications and
sequences
All content is linked to a module and
section
Significantly facilitates integration with eCTD
tools to produce submissions
Documents can be pulled directly into the correct
sequence, module and section within the eCTD tool

44. Version Control
How to control versions with RegDocs Connect

48. Version Control Benefits
What are the benefits of version control?
Can go back in time to see and compare different versions
Version comparison
Revision control can be enforced requiring proper rationale and
authorization
Revision control
Records of revisions are generated and can be used to
demonstrate proper process
Demonstrate proper process
Systematic versioning
All documents are systematically versioned by the system

49. Managing Correspondence
& Commitments
Managing correspondences & commitments with RegDocs Connect

51. Managing Correspondence & Commitments
Benefits
What are the benefits of managing correspondence and commitments?
No need to maintain a
tracker
Workflows assign tasks and
automate the commitment
process
Due dates can be
tracked
One central location for
recording correspondence
Allows different
commitments to be defined
and allocated

52. In Conclusion
Its not just about
technology, but also
process and people
Automating the
submission process is
key to speeding up
electronic
submissions and
reducing time to
market
The earlier you start
the easier it is
Implementing a
submission readiness
plan combined with a
strong technology
stack can have a
positive effect on
time to market
Look for integrated
technology stacks
which can be used
internally and
externally

53. Are you interested in receiving
more information about
Montrium’s RegDocs Connect?
1) Yes, could be useful
2) No, not interested
53
POLL
A B O U T T H E C O M P A N Y

54. QUESTIONS?
54A B O U T T H E C O M P A N Y

55. INFO@MONTRIUM.COM
Thank You!