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Transcript of Schlaps_Final
IT-Consulting
Life Science
From the IDMP Readiness Assessment and Gap Analysis to the selection of an IDMP Solution Architecture
Dr. Dieter Schlaps
IT-Consulting Life Science
1
Introduction
What is IDMP?
The ISO standards that represent IDMP
The IDMP data submodels and their
Interrelationships
Onboarding of Stakeholders
Identification of Stakeholders
Creating Stakeholder Awareness about the
Upcoming IDMP Standard
Agenda
2D.Schlaps; From IDMP Readyness Assessment...
What is IDMP*?
• Next wave in the pharmacovigilance legislation after xEVMPD
• Requiring data integration from the entire company
• The five ISO standards referred to as "ISO IDMP" were
approved in 2012
• Has a global scope and in Europe / US it will take effect by
2016.
* Identification of Medicinal Products
3D.Schlaps; From IDMP Readyness Assessment...
Goals of IDMP
• Clear mapping of international terminologies (Routes of administration, dosage forms, etc.) for accurate analysis and comparison
• Cross-border identifiability of medicinal products despite of different naming conventions
• Identifiability of all product’s component substances (not only those that are contained in a given safety report)
• Support the activities of medicines regulatory agencies worldwide (development, registration, life cycle management, pharmacovigilance and risk management)
4D.Schlaps; From IDMP Readyness Assessment...
The five ISO standards
ISO11615:2012 Health Informatics – Identification of medicinal products – Data elements and
structures for the unique identification and exchange of regulated medicinal product information
ISO11616:2012 Health informatics – Identification of medicinal products – Data elements and
structures for the unique identification and exchange of regulated pharmaceutical product
information
ISO11238:2012 Health Informatics — Identification of medicinal products – Data elements and
structures for the unique identification and exchange of regulated information on substances
ISO11239:2012 Health Informatics — Identification of medicinal products — Data elements
and structures for the unique identification and exchange of regulated information on
pharmaceutical dose forms, units of presentation, routes of administration and packaging
ISO11240:2012 Health informatics — Identification of medicinal products – Data elements and
structures for the unique identification and exchange of units of measurement
5D.Schlaps; From IDMP Readyness Assessment...
Implementation Guidelines for the ISO
standards have had 2-month Ballots now
prCEN ISO/DTS 20443 Health Informatics – Identification of medicinal products – Implementation Guide
for ISO 11615 for data elements and structures for the unique identification and exchange of regulated
medicinal product information
prCEN ISO/DTS 20451 Health informatics – Identification of medicinal products – Implementation Guide
for ISO 11616 for data elements and structures for the unique identification and exchange of regulated
pharmaceutical product information
prCEN ISO/DTS 19844 Health Informatics — Identification of medicinal products – Implementation Guide
for ISO 11238 for Data Elements and Structures for the Unique Identification and Exchange of Regulated
Information on Substances
prCEN ISO/DTS 20440 Health Informatics — Identification of medicinal products — Implementation
Guide for ISO 11239 for Data elements and structures for the unique identification and exchange of
regulated information on pharmaceutical dose forms, units of presentation, routes of administration and
packaging
No Implementation Guide for ISO 11240:2012: Unified Code for Units of Measure (UCUM) will be used
6D.Schlaps; From IDMP Readyness Assessment...
IDMP at a Glance
7D.Schlaps; From IDMP Readyness Assessment...
Identifiers and Terminologies
Slide Courtesy of Sabine Brosch, EMA (modified)
Terminology
Concepts
Packaging
Measurement Units
Dose Forms
Routes of
Administration
Presentation Units
By Jurisdiction
Across
Jurisdictions
Across
Jurisdictions
By Jurisdiction
By Jurisdiction
Across
Jurisdictions
Medicinal Product + Identifier
(MPID)
Substance/
Specified
Substance
+ Identifier
(SID & SSID)
Package + Identifier
(PCID)
Batch + Identifier
(BAID)
8D.Schlaps; From IDMP Readyness Assessment...
PhPID – MPID
Japan
Branded
Product
A
MPID 1
USA
Branded
Product
B
MPID 2
France
Branded
Generic
C
MPID 3
France
Generic
D
MPID 4
Germany
Generic
E
MPID 5
Germany
Generic
F
MPID 6
Canada
Branded
Product
G
MPID 7
Common
PhPID
Set
9D.Schlaps; From IDMP Readyness Assessment...
10
MPID 1
PhPID 1
MPID 2
MPID 3
MPID 4D.Schlaps; From IDMP Readyness Assessment...
MPID High Level Model
11D.Schlaps; From IDMP Readyness Assessment...
Introduction
What is IDMP?
The ISO standards that represent IDMP
The Medicinal Product according to IDMP
Onboarding of Stakeholders
Identification of Stakeholders
Creating Stakeholder Awareness about the
Upcoming IDMP Standard
Agenda
12D.Schlaps; From IDMP Readyness Assessment...
Why Six-Sigma-based Approach?
• Six Sigma is a systematic methodology
that utilizes information (management
by facts) and statistical analysis to
measure and improve a company’s
operational performance, practices and
systems by identifying and preventing
‘DEFECTS’ in business processes.
• It is a way of thinking about processes
where the focus is on proactive control
of process inputs rather than reactive
look at process outputs
13D.Schlaps; From IDMP Readyness Assessment...
14
6Sigma Methodology - DMAIC
D.Schlaps; From IDMP Readyness Assessment...
The Define/Measure phase is
crucial to the project's success
Activities
Define the problem, the
goal, and the process
Analyze stakeholders
Evaluate the performance of
the current process
Identify causes of poor
performance
Deliverables
Project charter and project plan
Business case
High-level (SIPOC) and detailed process
map
Customer requirements
Stakeholder Analysis
Long list of potential root causes
Data collection plan
Baseline performance
Quick wins
ControlImproveAnalyzeDefine/
Measure
15D.Schlaps; From IDMP Readyness Assessment...
The Define phase
Develop the Business Case
Translate the Voice of the Customer
High-level map the process
Create a Project Charter
16D.Schlaps; From IDMP Readyness Assessment...
17
SIPOC: High Level Process Mapping
SIPOC is a high-level process map identifying the Suppliers, Inputs,
Process Steps, Outputs, and Customers involved in the project
The aim of a high-level process map is to identify the process boundaries
for the project (start/stop) and create a common understanding
The process map is created starting from the customers of the process and
the outputs that they are demanding. Thereby, the SIPOC map provides a first
overview of customers
A SIPOC map should be high-level containing about 5-8 process steps
Customer
ProcessInput Output
Supplier
D.Schlaps; From IDMP Readyness Assessment...
Creating a SIPOC according to
the Snake method
Process:
S I P O CSuppliers Inputs Process Outputs Customers
Sta
rt b
ou
nd
ary
Sto
p b
ou
nd
ary
The List method considers the link between Suppliers and Inputs and Outputs
and Customers, respectively.
Using the Snake method you take into account that the Output / Customer of a
specific process step can be an Input / Supplier for the following process step. 18D.Schlaps; From IDMP Readyness Assessment...
Application of SIPOC Charts to identify
roles and responsibilities in IDMP
a.) New Product Scenario
Who creates IDMP- relevant data in which stage (Draft, Final, Official) when and
for whom:
Identification of stakeholders
Identification of deliverables
Collection of „Critical- to-Quality“ Factors and high-level Business Requirements
Identification of source systems
SIPOC
b.) Product Maintenance/ Change Scenario
19D.Schlaps; From IDMP Readyness Assessment...
New Product
SIPOC Example (1)Process:
S I P O CSuppliers Inputs Process Outputs Customers
Global Project
Management, Regulatory
Management Responsible
Feasibility Study
Global Project
Management, Regulatory
Management Responsible
Project Plan and Budget
Global Project
Management, Regulatory
Management Responsible
Definition of Project Characteristics
Regulatory Management
ResponsibleDevelopment application strategy
Regulatory Management
ResponsibleScientific/ Regulatory Advice
? Decision for New Application
Regulatory Management
ResponsibleCommunicate deadline and scope
Regulatory
Submissin
Mgr
Submitting Unit
ResponsibleCompile project plan
Reg. Subm.
Authors and
various actors
Submitting Unit
Responsible
Communicate PP and request
documents
Requested documentation,
timelines
Various
actors,
External
providers
Various actors, External
providers
requested
documentationCreate/ provide documents M1-M5 documents
Submitting
Unit
Responsible
Submitting Unit
ResponsibleM1-M5 documents
Check completeness and plausibility
on single-document level
Flagged documents with
comments
Various
actors,
External
providers
Submitting Unit
ResponsibleM1-M5 documents
Check-in documents, dossier
compilationAccepted docs in DMS
Submitting Unit
Responsible
Accepted cosuments
in DMS, Dossier
(parts)
Check completeness, carry out gap
analysis and plausibility on single-
document level
Gap analysis,
complete dossier
Regulatory
Management
Responsible
Regulatory Management
ResponsibleCompleted dossier
Carry out publishing and technical
validationValidated package
Submitting
Unit
Responsible
Submitting Unit
Responsible
Finalized and
validated packageSubmit package to HA Electronic Submission HA
Submitting Unit
Responsible
Finalized and
validated package
Request (corr.) translation of product
informationProduct Information Various actors
Various actors Product Information Translate/correct Product InformationTranslated product
information
Submitting
Unit
Responsible
(Local/
Maintenance)
Submitting Unit
Responsible (Local
Affiliate/ Maintenance)
Translated Product
Information
Check translation of product
information
Revised/ corrected product
informationVarious actors
Submitting Unit
Responsible (Local
Affiliate/ Maintenance)
Corrected Product
Information
Finalize National Product Information
and submit package to National HA
Final National Product
InformationNational HA
Submitting Unit
ResponsibleTrack application status
Submitting Unit
ResponsibleDeficiency Letter Receive and analyze Deficiency letter
Submitting Unit
ResponsibleRequest response (with deadline)
Various internal/ external
authors
Various internal/ external
authorsinformation request Create/ rework response documents Submitting Unit Responsible
Submitting Unit
Responsibleresponse document
Check completeness and plausibility
on single-document level
Flagged document with
comments
Various
actors,
External
providers
Submitting Unit
Responsible
Corrected response
document
(If needed:) Compile and submit draft
responseDraft response HA
Regulatory Management
Responsible
Corrected response
document
(If needed:) Publishing and technical
validationValidated package
Submitting
Unit
Responsible
Submitting Unit
ResponsibleValidated package
(If needed:) Complete and submit
packageValidated package HA
Submitting Unit
Responsible
Deadlines, tracking
dataUpdated tracking data
New Product
Subm
issio
n t
o H
A o
f appro
ved p
ackage w
ith p
relim
inary
transla
tion o
f pro
duct
info
rmation
Subm
issio
n o
f finaliz
ed N
ational P
roduct
Info
rmation
Pro
ject
Pro
posal
Decis
ion f
or
New
Applic
ation
Subm
issio
n t
o H
A
Decis
ion f
or
New
Applic
ation
Subm
issio
n t
o H
A
HA
Accepta
nce
20
Product Maintenance and Change
SIPOC Template (2)Process:
S I P O CSuppliers Inputs Process Outputs Customers
Management of post-approval
commitments
Conduct of post-approval studies
and patient-related activities
Provision of product information
for Healthcare Professionals,
public and patients
Regulatory management of
marketed products and regulatory
life cycle managementSafety management of marketed
products and life cycle
managementProduct Quality Management
Production and Production
Change Management
Decision to carry out a variation
for the envisaged change
Prepare modified documentation
and justification
Prepare and submit updated
information to HA
Negotiation and approval of
requested changes
Execution of approved changes
(label translation, release of new
BOM, etc.)
Ma
rke
t L
au
nc
h
Te
rmin
ati
on
of
Ma
rke
t S
up
ply
IDMP Data
Product Maintenance
21D.Schlaps; From IDMP Readyness Assessment...
Stakeholder Analysis:
Perceived Challenges, Benefits, Prerequisites and
Requirements
Your feedback
Potential Challenges Potential Benefits
Essential
Prerequisites
Perceived
Requirements
22D.Schlaps; From IDMP Readyness Assessment...
The Measure/ Analyze phases
Identify potential causes
Develop a data collection plan
Verify the measurement system
Identify patterns in data
Determine baseline process capability
Count
Percent
C4Count
32.4 9.7 6.8 5.3 2.4
Cum % 43.5 75.8 85.5 92.3
90
97.6 100.0
67 20 14 11 5
Percent 43.5
OtherAEGBC
200
150
100
50
0
100
80
60
40
20
0
Cpk=0.36
Yield=86.2%
Process
Sigma=2.6
Prioritize potential causes
23D.Schlaps; From IDMP Readyness Assessment...
The Gap Analysis
Understanding the IDMP Data Requirements
Creating a Data Collection Plan
Verifying the Data Collection Approach with
Selected Products
Defining the Selection Strategy
Manual Collection of IDMP Data
Revisiting the Critical-to-Quality Factors
Agenda
24D.Schlaps; From IDMP Readyness Assessment...
IDMP Data
Model
25
Closer look at the IDMP data, where it is originating from
and where it is used
26D.Schlaps; From IDMP Readyness Assessment...
Example Results
27D.Schlaps; From IDMP Readyness Assessment...
Example:
Outcomes from Define phase
As-Is Process to acquire IDMP Data:
- Only a few databases are relevant for IDMP; many data is only
contained in documents
- Substance data not available in the (Generics) company
- Regulatory Affairs, Drug Safety, Medical Affairs, Supply Chain
and Affiliates are the main stakeholders to be involved
- IDMP data acquisition tests are necessary because of product
variabilities
- XML data structure to be used for the data acquisition process
28D.Schlaps; From IDMP Readyness Assessment...
The Gap Analysis
Understanding the IDMP Data Requirements
Creating a Data Collection Plan
Verifying the Data Collection Approach with
Selected Products
Defining the Selection Strategy
Manual Collection of IDMP Data
Revisiting the Critical-to-Quality Factors
Agenda
29D.Schlaps; From IDMP Readyness Assessment...
Selection Criteria for Products to be included in
IDMP Sample RunP1 P2 P3 P4 P5 P6 P7 P8 P9 P10
Medicinal Product Variations
Combination Product
Single Strength
Multiple Strengths
Manufacturer
Single Manufacturer
Multiple Manufacturers with different manufacturing tasks
Production
Internally produced
Externally produced
Marketing
Marketed by Internals
Marketed externally
Packaged Medicinal Product
Tablets
Liquid
Gel/ Cream
Aseptical Preparation
Active Ingredients
Only 1 Active Ingredient
Multiple Active Ingredients
Devices
Included
Without Device
Priorities
"Bread and Butter"
"Potential Blockbuster"
"Old/ New Products"
Products from Portfolio
30
Pros and Cons of using xml as the format
for the Data Acquisition
xml schema for IDMP had to be created that represents the IDMP data model
Example xml files can be created from the schema and taylored to match the customer‘s
products profile
Data groups (e.g. another CMO for a given product) can be added easily, copy and paste is
much easier in general
Data grouping is according to the IDMP data model (e.g. „Medicinal Product“)
Before a product xml file is stored, it can be validated against the IDMP data model
Graphical and text-based editing support
„Intelligent“ comparisons of xml files of different products
By copying xml files and modifying e.g. the medicinal product name registration data
multiple registrations can be handled easily
31D.Schlaps; From IDMP Readyness Assessment...
Why xml is also a useful basis for the further
implementation work
As long as there is no dictionary database used for the vocabularies, CV data needs to be
entered again and again
but:
Based on the xml schema, a database can be created that holds the data being created as
well as the dictionaries („Identity constraints“, resp. „key/ keyref“ attributes to be added to
xml structure)
Data that was captured in xml can be uploaded to the database and the database can be
used to acquire the IDMP data
Test data for the pilot can be collected
Substance data downloaded from GInAS can be mapped to the IDMP data model
Valuable material and data for the Requirements and Implementation Phase
32D.Schlaps; From IDMP Readyness Assessment...
The XML Schema used for the Analysis
33D.Schlaps; From IDMP Readyness Assessment...
The
Data
Collection
Process (1)
34
The Data
Collection
Process (2)
35
The Data Collection Process(3)
36D.Schlaps; From IDMP Readyness Assessment...
From Example: The Data Collection Process
Reevaluation of CTQs
37
Towards IDMP Implementation
Defining the Future Processes
Defining a High-Level Solution Architecture
Collecting User Requirements and RFP
Agenda
38D.Schlaps; From IDMP Readyness Assessment...
Future Process Design
• Based on Use Cases (see below)
• For each Use Case, the following description is provided:
- Goal of UC
- Scope
- Pre- and post conditions
- Process flowchart
- Actors and their interests
- Open issues
- Numbered, tabulated Requirements relating to the UC (with priorities and
CTQ references)
• Other requirements (Data, Organization etc.)39D.Schlaps; From IDMP Readyness Assessment...
High-Level Solution Architecture
Identification of Use Case Document
&
Structured
Content-
Manage-
mentSubstance
Data Base
(e.g.
GInAS)
ERP
Plat-
form(s) to
exchange
data with
Ext. P.
Drug
Safety
SystemMaster
Data
Manage-
ment
IDMP/ RIMS
Solution
EMA/ FDA
Substance
Databases
CROs,
CMOs
Public
Dictionaries
Health Autho-
rities
UC3
UC2UC4
UC1
UC1:
Create, update, review
and approve IDMP
data
UC2:
Submit IDMP data
UC3:
Maintain Controlled
Vocabularies
UC4:
Collect IDMP data from
other systems
40D.Schlaps; From IDMP Readyness Assessment...
Characteristics of New Process
• To be triggered by Product Submission process
• Departments are responsible for the provision for their parts of
the IDMP data
• Solutions will be provided to support the process of data
collection
• External manufacturers and affiliates need to be involved, too
• Master data/ Dictionary management needs to be implemented
• Product Responsible carries over-all responsibility
41D.Schlaps; From IDMP Readyness Assessment...
Questions?
42D.Schlaps; From IDMP Readyness Assessment...
IT Consulting Life ScienceHaider Straße 3082405 WessobrunnGermany
email: [email protected]: +49 (0) 160 96067530fax: +49 (0) 8809 163091
Your Contact
Dr. Dieter Schlaps
Thank you very much for your Attention!
D.Schlaps; From IDMP Readyness Assessment... 43