The document outlines the identification of medicinal products (IDMP) and the benefits of a master data-driven approach, detailing Cuneso GmbH's regulatory software solutions and project methodologies. It highlights the complexities of IDMP implementation, the required data management, and the company's ramp-up program aimed at facilitating compliance by using integrated software tools. Additionally, it emphasizes the necessity of centralized master data management to ensure regulatory compliance and streamline submissions.

1. www.cuneso).com
sales@cuneso).com
©
2015
Cuneso-
GmbH
IDMP
–
Iden8fica8on
of
Medicinal
Products
A
master
data
driven
approach
and
it‘s
benefits
Rainer
Schwarz
Daniel
Koppers
May
7th,
2015

2. ©
2015
Cuneso-
GmbH
2
Increased
Data
Scope
xEVMPD
-­‐
30
-­‐
IDMP
-­‐
250
to
500
-­‐
July
2012
July
2016
Due
Date
Structured
Informa<on
items/product
100
200
300
400
500
16x
more
data

3. ©
2015
Cuneso-
GmbH
3
IDMP
–
A
master
data
driven
approach
and
it‘s
benefits
§ Introduc8ons
§ IDMP
Summary
&
Status
§ Regulatory
Master
Data
Concept
§ Case
Study:
So-ware
based
IDMP
§ Cuneso-
IDMP
Ramp
Up
Program
§ Q&A

4. ©
2015
Cuneso-
GmbH
4
Company
Overview
Venture
Partners:
Rainer
Schwarz
CEO
§ More
than
14
years
experience
with
compliant
so-ware
solu8ons
for
regulated
processes
§ Senior
management
posi8ons
at
CDC
Solu8ons,
Liquent
and
NextDocs
§ Business
experience
in
Europe,
USA
and
Asia
§ Master
of
Social
Sciences
of
the
University
of
Innsbruck
and
Hong
Kong
University
!
Daniel
Koppers
CTO
§ More
than
7
years
experience
with
so-ware
development
and
project
management
§ Deep
knowledge
of
life
sciences
and
regulated
industries.
Regula8ons
know-­‐how
such
as
CFR
21
Part
11
and
GxP
valida8on
§ Expert
in
Microso-
technologies
§ Degree
in
Business
Informa8cs
!
Recogni<on
and
Cer<ficates:
ISO
27001/27002
„Regulatory
processes
done
right“
Headquarters:
Munich,
Germany
Regional
Office:
Paris,
France
Established:
2013
Team
Size:
15
Business:
Provides
pioneering
regulatory
so-ware
Technology
Partner:
Microso-
Website:
www.cuneso-.com

5. ©
2015
Cuneso-
GmbH
5
Integrated
Regulatory
SoXware
cune-­‐
RDMS
cune-­‐Portal
cune-­‐
IDMP
cune-­‐
Track
cune-­‐
eCTD
Ø cune-­‐RDMS
Create,
review,
approve
and
sign
submission
related
documents
according
to
FDA
21CFR
part
11
requirements.
Ø cune-­‐eCTD
Create
new
or
import
exis8ng
electronic
submissions
and
compile
all
types
of
eCTD
submissions
including
eCTD
lifecycle
management.
Ø cune-­‐Track
Create
a
submission
data
base,
track
all
regulatory
events
and
include
authority
correspondence
in
one
comfortable
system.
Ø cune-­‐SOP
Manage
Standard
Opera8ng
Procedures
(SOP’s)
from
beginning
to
end.
Distribute
to
employees
and
automa8cally
track
training
records.
Ø cune-­‐IDMP
-­‐
new
Holis8c
Regulatory
Master
Data
Management
to
manage
pharmacovigilance
related
submissions
such
as
xEVMPD,
IDMP
based
on
HL7
output
standards.
Integrated
Regulatory
SoXware
-­‐
What
we
do
cune-­‐
SOP

6. ©
2015
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6
Introduc<ons
IDMP
–
Iden8fica8on
of
Medicinal
Products
ISO
11615
ISO
11616
ISO
11238
ISO
11239
ISO
11240
Medicinal
product
informa<on
Pharmaceu<cal
product
informa<on
Pharmaceu<cal
dose
forms,
units
of
presenta<on,
routes
of
administra<on
and
packaging
Substances
Units
of
measurement
Five
ISO
standards
define
the
framework
(approved
in
2012)

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2015
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7
Dossier
Manufacturing
Pharmaceu8cal
Product
Packaged
Product
Medicinal
Product
MPID
(S)SID
PhPID
PCID
IDMP
codes
IDMP
Gateway
Mandatory
(July
2016
for
EU)
Introduc<ons
IDMP
–
Iden8fica8on
of
Medicinal
Products
MPID
–
Medicinal
Product
ID
(S)SID
–
Substance
ID
PhPID
–
Pharmaceu8cal
Product
ID
PCID
–
Packaged
ID

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2015
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8
Introduc<ons
IDMP
–
Iden8fica8on
of
Medicinal
Products
Some
helpful
known
facts:
1. Legisla8ve
requirement
for
all
European
MAH
from
July
1st
of
2016
2. ISO
IDMP
guidelines
provide
a
complete
data
model
framework
3. Implementa8on
guides
(IG)
have
not
been
defined
as
of
today
4. IG‘s
will
provide
instruc8ons
mandatory/op8onal
fields/
business
rules/
data
types
5. ISO
11238
-­‐
Global
Ingredient
Archival
System
(GInAS)
will
be
used
6. ISO
11239
-­‐
Pharmaceu8cal
dose
forms
/
units
of
presenta8on
/
routes
of
administr.
(EDQM)
will
be
used
7. ISO
11240
-­‐
Unified
Code
for
Units
of
Measure
(UCUM)
will
be
used
8. Submission
format
will
be
based
on
the
norma8ve
messaging
standards
i.e.
HL
7
standard

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IDMP
–
Substance
Data
Model
–
Part
I
*
Source:
ISO
11616
-­‐
PhPID
model:
GLUBRAVA®
(pioglitazone
and
memormin)
Sources
GInAS
EDQM
UCUM
Manual
Defini8on

10. ©
2015
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10
IDMP
–
Substance
Data
Model
–
Part
II
*
Source:
ISO
11616
-­‐
PhPID
model:
GLUBRAVA®
(pioglitazone
and
memormin)
Sources
GInAS
EDQM
UCUM
Manual
Defini8on

11. ©
2015
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IDMP
–
Challenges
resul<ng
from
the
data
model
1.
Complex
data
model
• IDMP
is
much
more
than
just
an
extension
to
xEVMPD
• It
is
a
detailed
descrip8on
of
o Substances
o Produc8on
procedures
o Other
ingedrients
o Packaging
2.
Distributed
sources
of
informa<on
• ERP
System(s)
• Regulatory
Opera8ons
System
(Submissions,
RIM
etc.)
• Proprietary
legacy
data
such
as
Excel
• External
partners
(CMO,
CRO
etc.)
• External
data
repositories
(such
as
EVWeb)
• Paper
documenta8on
3.
Required
ini<al
change
management
• Consolida8ng
data
sources
• Cleaning
data
• Centralizing
data
into
one
summary
IDMP
repository
4.
Required
on-­‐going
data
accuracy
• Con8nuous
data
updates
• Tracking
of
data
changes
• Upda8ng
exis8ng
submissions

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2015
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Alterna<ves
on
how
to
approach
IDMP
challenges
1. Manual
data
collec8on
and
data
entry
into
EVWEB
2. Outsource
to
a
service
provider
3. Tac8cal
use
of
a
(simple)
so-ware
tool
4. Strategic
approach
via
seeing
it
as
a
chance
for
change
5. Use
a
combina8on
of
the
above
§ Does
manual
data
management
scale
for
more
than
one
product
?
§ Since
IDMP
is
not
just
an
extension
to
xEVMPD,
is
there
a
tac8cal
way
at
all
?
§ How
effec8ve
can
outsourcing
be,
to
gather
complex
internal
data
?
§ If
a
„simple“
so-ware
tool
is
being
used,
how
much
manual
work
remains
?
§ What
would
be
the
benefits,
if
IDMP
is
seen
as
chance
for
change
?
§ Since
the
data
requirements
are
complex,
what
else
besides
the
IDMP
submission
can
be
done
with
all
the
data
?
§ What
would
be
the
detailed
solu8on,
if
IDMP
is
approached
strategically
Possible
solu<ons
alterna<ves:
Ques<on
that
might
help
to
decide:

13. ©
2015
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13
Strategic
Approach
-­‐
Regulatory
Master
Data
Management
(R-­‐MDM)
Requirements
for
an
IDMP
compliant
R-­‐MDM
Regulatory
single
source
of
truth
• Centralized
database
containing
latest
informa8on
• Synchronized
automa8cally
• Federated
into
one
well
defined
data
core
–
automa8cally
Include
external
systems
• Connect
external
systems
and
reuse
exis8ng
data
• Well
defined
concise
API‘s
supported
by
most
modern
systems
• Direct
database
connec8ons
into
clear
database
schemas
Reports
and
Sta<s<cs
• Limit
unnecessary
data
redundancies
• Standard
reports
for
daily,
weekly,
monthly
regulatory
repor8ng
• Re-­‐use
exis8ng
repor8ng
systems
to
capitalize
on
data
mining
"With
the
increasing
focus
on
digitaliza8on
of
enterprises,
management
of
their
key
master
data
is
also
becoming
more
important.
The
ability
to
achieve
and
maintain
a
single,
seman8cally
consistent
version
of
product
master
data
is
crucial
for
customer-­‐centric
organiza8ons."
Source:
The
Gartner
Group
IDMP
submission
crea<on
and
maintenance
• Produce
compliant
IDMP
data
output
• Reduce
manual
work
via
gateway
connec8ons
• Business
rules
func8ons
for
automa8c
data
updates
Federated
Share
Synchronise
Core

14. ©
2015
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IDMP
–
Data
Ecosystem
Regulatory
Master
Data
„Single
Source
of
Truth“
UCUM
EDQM
GInAS
Contract
Manufact
urers
CRO‘s
API
Supplier
Data
Input
Processing
Data
Output
Submissions
Ø IDMP
Ø Other
HL7
Output
Ø eCTD
Ø eCTD
4.0
Ø Adverse
Events
Ø ICSR
Regulatory
Infoma<on
Ø Submission
Planning
Ø Renewal
No8fica8ons
Ø Early
Warning
Ø Overdue
No8fica8ons
Task
Management
Ø Task
Distribu8on
Ø Resource
Manageement
Ø Affiliates
Management
Regulatory
Reports
Ø Repor8ng
Ø Regulatory
KPI
Tracking
eCTD
Excel
xEVMPD
ERP
Regulatory
Archive
Ø Submissions
Archive
Ø Documents
Archive
CTMS

15. ©
2015
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IDMP
–
Data
Ecosystem
Regulatory
Master
Data
Manager
Data
Input
Processing
Data
Output
cune-­‐
RDMS
cune-­‐Portal
cune-­‐
IDMP
cune-­‐
Track
cune-­‐
eCTD
cune-­‐
SOP
Submissions
Ø IDMP
Ø Other
HL7
Output
Ø eCTD
Ø eCTD
4.0
Ø Adverse
Events
Ø ICSR
Regulatory
Infoma<on
Ø Submission
Planning
Ø Renewal
No8fica8ons
Ø Early
Warning
Ø Overdue
No8fica8ons
Task
Management
Ø Task
Distribu8on
Ø Resource
Manageement
Ø Affiliates
Management
Regulatory
Reports
Ø Repor8ng
Ø Regulatory
KPI
Tracking
Regulatory
Archive
Ø Submissions
Archive
Ø Documents
Archive

16. ©
2015
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cune-­‐RDMS
Import
Documents
Regulatory
Templates
Review
and
Approve
Electronic
Signature
cune-­‐eCTD
Import
or
New
eCTD’s
Auto
Compile
Check
Compliance
Submit
to
Gateway
cune-­‐Track
Track
registra8on
tasks
Assign
regulatory
tasks
Monitor
via
workflows
Automa8c
no8fica8on
cune-­‐SOP
SOP
Management
Training
Records
FORMS
Management
Change
Control
Regulatory
Master
Data
Management
External
Data
Import
Repor<ng
Submission
Prepara<on
• User
friendly
regulatory
• Based
on
xEVMPD
and
ISO
IDMP
models
• Includes
smart
access
to
external
databases
• Integrated
with
GInAS
• Integrates
with
UCUM
• Integrates
with
EDQM
cune-­‐IDMP
cune-­‐IDMP
Master
Data
xEVMPD
Submissions
IDMP
Submissions
HL7
Support
• Imports
historical
EVMPD’s
and
xEVMPD’s
• Connects
your
external
business
partners
(i.e.
CRO’s,
CMO’s
etc.)
via
a
secure
data
management
portal
to
have
them
share
their
IDMP
relevant
data
• Gains
you
unprecedented
regulatory
data
insight
via
dynamic
reports
and
by
u8lizing
rich
filtering
capabili8es.
• Shapes
regulatory
data
based
on
needs
by
applying
sor8ng,
filtering,
grouping
and
adding
addi8onal
meta
data
fields.
• Facilitates
automated
business
rules
based
on
a
variety
of
triggers
such
as
external
or
internal
data
changes,
regula8on
changes
or
other
external
factors.
• Publishes
xEVMPD,
IDMP
HL7
compliant
submissions
and
other
(future)
submission
formats.

17. ©
2015
Cuneso-
GmbH
17

18. ©
2015
Cuneso-
GmbH
18
IDMP
–
A
master
data
driven
approach
and
it‘s
benefits
§ Introduc8ons
§ IDMP
Summary
&
Status
§ Regulatory
Master
Data
Concept
§ Case
Study:
So-ware
based
IDMP
§ Cuneso-
IDMP
Ramp
Up
Program
§ Q&A

19. ©
2015
Cuneso-
GmbH
19
IDMP
–
CunesoX
Ramp
Up
Program
–
email:
info@cuneso8.com
Step
1
Data
Analysis
1.
IDMP
Test
System
Access
2.
Delta
Data
Workshop
(xEVMPD
versus
IDMP)
3.
Analyse
Data
Sources
§ xEVMPD
§ Pharmaceu8cal
Product
§ Manufacturing
§ Packaged
Product
Result:
Data
Analysis
Summary
Free
–
Register
Now
Step
2
Data
Collec<on
&
Entry
1.
IDMP
Test
System
Access
2.
Data
Assembly
§ GiNAS,
UCUM,
EDQM
§ External:
CMO,
CRO,
API
etc.
§ Internal
Submission
Import
§ Internal
Legacy
Import
(Excel)
§ Internal
Paper
Based
Data
§ Internal
Manual
Data
Entry
Result:
IDMP
Data
Report
Services
Fees
Step
3
IDMP
Submission
Prepara<on
1.
IDMP
System
Rollout
§ Configura8on
§ API
connec8ons
§ Valida8on
§ User
Training
2.
Cc‘d
Data
Collec8on
&
Entry
3.
Regulatory
Repor8ng
Result:
IDMP
Submission
So-ware
License
&
Services
Fees
May-­‐June
Jul-­‐Sep
From
Oct

20. ©
2015
Cuneso-
GmbH
20
IDMP
–
A
master
data
driven
approach
and
it‘s
benefits
§ Introduc8ons
§ IDMP
Summary
&
Status
§ Regulatory
Master
Data
Concept
§ Case
Study:
So-ware
based
IDMP
§ Cuneso-
IDMP
Ramp
Up
Program
§ Q&A

21. ©
2015
Cuneso-
GmbH
21
Become
a
happy
customer
!
Rainer
Schwarz
Email:
info@cuneso-.com
Tel:
+49
(0)89
235
14
741