Learn why RIM is becoming software no.1 to life science companies and how cune-RIM can help you with increasing number of requirements from regulatory authorities, increasing submission complexity and burden, increasing costs and inefficient work. You grew out of spreadsheets long time ago - it's now time for Regulatory Information Management (RIM)! Watch our webinar recording here: https://cunesoft.com/en/downloads/webinar-library/ or visit cune-RIM page directly: https://cunesoft.com/en/products/rim/

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TRUTH
RIM
RIMEverybody
deserves the

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Q&A Session
What is the TRUTH?
The Promise of Regulatory Information
Management (RIM)
The Path to the Truth
How RIM Addresses True Needs
You Deserve the Truth
Conclusion
Introducing Cunesoft
Index
RIM3
2
1

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„Regulatory peace of mind“
Jim
Nichols
VP, Life
Sciences NA
Introducing Cunesoft
Headquarters: Munich, Germany
Regional Offices: Paris, Bangalore, Princeton
Industry Focus: Regulatory Software for Life Sciences
Venture Partners: HTGF, Bayern Kapital, Occident Group
Corporate Facts Global Life Sciences Customer

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What is ‘Truth’?
Truth is most often used
to mean being in accord
with fact or reality

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Some Key Realities
More requirements by regulatory authorities
Increasing submission burden and complexity
Inefficient processes increase costs
Unclear ownership creates confusion

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Today’s Truth for Regulatory Information
is often not connected to relevant information
Important
regulatory
information
lacks clear ownership
is often duplicated
is missing
is out of date
is not globally available
2x
Best
before

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Yet Everybody Deserves the Truth
Having a ‘single source of the truth’
has many benefits
Enables
greater
efficiencies
Improves
organizational
compliance
Improves
Your
business
Creates a
single and
commonly
understood
collection of
information

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The Promise of Regulatory Information Management (RIM)
Comprehensive Regulatory Information Management (RIM)
will help life sciences organizations effectively and efficiently
drive the development, capture, dissemination, control and
management of regulatory-focused content throughout the
product lifecycle.
Examples of addressable challenges:
Affiliate
Engagement
Managing Product
Changes
Current & Accurate
Registration Status
Compliance With
New Requirements

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Let’s Describe FirstRIM

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Our View of RIM
RIM
Products
Registrations
Submissions
DocumentsLifecycle
Management
Clinical
Commitments &
Correspondence
Do I have the Clinical
Study information I
need for my
submissions?
When are my product
renewals and updates
due?
How am I capturing and
responding to HA
requests?
Which documents are
approved for use?
What am I submitting
to achieve and
maintain registration?
Where are my products
registered?
What are my product
families and products?

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The Path to the Truth

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Documents, Workflows, Tasks
RIM means Relationships
Product Family
Product
Registration 1 Registration 2

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Documents, Workflows, Tasks
INSULIN GLARGINE RECOMBINANT
Registration 1 @ FDA
Lantus Solostar Lantus
An Example
05/01/2003 SUPPL-5 Efficacy-New Dosing Regimen 04/20/2000 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD
300 UNITS/3ML (100 UNITS/ML) INJECTABLE 100 UNITS/ML INJECTABLE

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Follow the Path to Find
the Truth

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Products
You will want to…
– Be able to group your products logically
– Capture all of the product details needed to support submission
requirements such as xEVMPD and eventually IDMP
– Leverage controlled vocabularies to ensure consistency across
products

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You will want to…
–Associate your registration details with one or more products
–Capture key registration information for ongoing maintenance
–Provide comprehensive reports on product registration status on demand
Registrations

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You will want to…
–Understand your submission workload across the organization
–Enable your affiliates to engage in the submission and registration process
–Track task assignments for those involved in the submission process
Submissions

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You will want to…
–Create and manage documents related to your products
–Leverage product information for document metadata
–Seamlessly provide documents to the submission compilation process
Documents

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You will want to…
– Have a central view of all PLM activities such as variations, PSURs, Renewals and Periodic
Reports
– Leverage automated notifications and reminders for upcoming deadlines
– Build upon prior activities to ensure compliance and efficiency
Lifecycle Management

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You will want to…
–Capture correspondence artifacts and associate them to actions and tasks
–Track all commitments to regulatory authorities centrally
–Utilized task assignments and notifications to ensure timely responses are provided
Commitments & Correspondence

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You will want to…
–Have key study details
available for use in
submissions
–Be able to associate
study information with
relevant documents
–Update regulatory
authorities with new
study data as studies
complete
Clinical

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Addressing True Needs

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Realtime Product Registration Information

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Better Enable Affiliates with Information Sharing

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Manage Product Changes Globally

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Comply with New Requirements
Substance management service (SMS):
harmonized data and definitions to uniquely
identify the ingredients and materials that
constitute a medicinal product
Product management service (PMS):
harmonized data and definitions to uniquely
identify a medicinal product based on
regulated information (e.g. marketing
authorization, packaging and medicinal
information)
Organizations management service (OMS):
data comprising organization name and
location address, for organizations such as
marketing authorization holders, sponsors,
regulatory authorities and manufacturers
Referentials management service (RMS): lists
of terms (controlled vocabularies) to describe
attributes of products, e.g. lists of dosage
forms, units of measurement and routes of
administration
Benefits of SPOR services
• Implementing the SPOR data management services
offers a number of key benefits for the regulation of
medicines:
• increased data quality and simplification of data
management practices, since data will be reviewed,
assessed and approved as part of the new data
operating model;
• more efficient regulatory action and decision-
making, thanks to improved data integrity and
reliability;
• regulatory requirements can be met more
effectively, by reducing data silos and improving
interoperability across EU systems;
• operational savings and efficiencies can be
achieved, as pharmaceutical companies need
to supply regulatory data only once, which will be
re-used across different procedures and regulators.
These operational benefits should have a positive
impact on public health and safety.

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xEVMPD – Automate the truth
It is a simple process
1. You download all your data from EV
Web and import that into an xEVMPD
data management software
2. You register for the free gateway
connection
3. You start receiving and sending
xEVMPD data automatically
With the help of customers we
calculated that you start
saving money
if you have more than
25 products
that you maintain under Article 57.
RIM EMA

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Boost your database with the IDMP data model
The Truth Today
– We are at least 2 years away from IDMP submissions. But data preparation cannot start early
enough. As mentioned before, SPOR and controlled vocabulary management will be required as
interim data management.
– You have some type of Article 57 data management process in place. Worst case it is in a
spreadsheet only. Best case you have an automated software that connects to the EMA gateway.
Most likely, you have something in the middle, semi automated.
– Whatever you have in place right now, it should be expandable with the IDMP data model. The
IDMP data model requires significant additional data capturing. Even if IDMP submissions are not
due yet to be submitted, you can start preparing the data.
If you have a spreadsheet-based approach, then it’s probably the right time to consider moving to a
software-based approach. If you have an Article 57 data management system in place, then we
recommend you to ask your technology provider, whether he can upgrade your current database with
IDMP relevant data.

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You Deserve the Truth

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Change the systems
for managing health
authority
interactions
Market overview – Gens Report 2016
Reference
Gens and Associates, Pursuing World Class Regulatory Information Management (RIM); Strategy, Measures, and Priorities (September 2016).
Implement end-to-
end process
ownership and
governance roles
41% 65% 86%73%45%
Embark on a
transformational
change
Change the
submissions content
management
systems
Change the
submission
planning
systems
Future trendsProven benefits
more likely to realize
business benefits
2.5x 18%3.5x
more efficientmore confidence in the
data quality

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Dissolve data silos and create your regulatory single source of truth
The Truth Today
– You have many other databases and sources
within your organization. Substances might be
stored in your substance system, your submission
system and are part of your Article 57 data in a
third database.
– Maybe your MedDRA coding is based on another
version than the latest available version.
– You are probably unsure that the indications in
your SMPC’s match the indication information
submitted to the health authorities.
– There are data silos and departmental ways of
thinking which evolved as requirements came
into place. Piece by piece, point solutions have
been put in place.
Compliance requirements will grow further and the
risk of being non-compliant will increase with the
level of point solutions and data silos that you might
have in place. Creating the regulatory single source
of truth can help to reduce daily work and increases
compliance.
RIM
FDA
EMA

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The Truth Is…
At its core, RIM means having a central, unified and meaningful
collection of information that ensures and enables operational
efficiency and organizational compliance
RIM
There are several definitions of RIM right now – find the right one for you
Attempting to manage via disparate systems and spreadsheets is high-risk and
inefficient – centralize your information
No matter the size of your organization, the burden and needs are the same –
ignoring the problem is not an option

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Your Questions

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Regulatory Information Management
Connect Your Truth
Become A Happy Customer !
Email: info@cunesoft.com
DE-Tel: +49 (0)89 235 14 741
US-Tel: +1 (609) 955-3468