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WEBINAR #5
INTEGRATED PRODUCT INFORMATION MANAGEMENT
A pragmatic approach towards interoperability
20 March, 2018
Introductions and objectives
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Lunyan Zhu
Lunyan Zhu
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Rens van den Boomen
Adnan Jamil
Consultant
• IDMP SME and business
architect
• Focus on system and business
process integration, Regulatory
Information Management,
system development, evaluation
and implementation
Consultant & Marketing
Lead
• IDMP consultant specialized
in IDMP iteration 2
• Successfully executed
several IDMP assessments
Associate Director
• > 13 years experience in the
Life Sciences Industry
• IDMP SME, program manager
with focus on Regulatory
Compliance, PV, Business
process improvement &
Strategy Implementations
Today’s speakers
Objectives of today’s webinar
• To provide you with our perspective
• To introduce our Maturity Model
• To share practical examples
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The common thread throughout our webinar series
was integrated product information management
RIMS, IDMP, SCA and ERP-RIMS as enablers of your business processes
RA as product information advisor and broker
Interoperability is a marathon, not a sprint
Structured Product Information as an asset
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Introducing the Maturity Matrix
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Rens van den Boomen
Today’s pharmaceutical industry is facing a multitude
of product information related challenges
Annual increase Volume • Product data and information volumes
Necessity and availability Quality • High quality structured product information
Scrutiny Regulatory • Data consistency, quality and reporting requirements
Information Sharing Organisation • E2E cross silo processes
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To increase organisational effectiveness a fundamental
change of thinking is required
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What are our
governance needs e.g.
roles, definitions, data
quality, data security…?
How can I distillate and
maintain high value data of
an ever growing information
stream?
How can I manage,
facilitate and influence
cross functional
processes?
Is our technology
capable of supporting
our business needs?
Providing the right people with the right info in the
right format at the right time to make the right decision
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Integrated Product Information
Management
Implementing Integrated Product Information
Management is a marathon, not a sprint
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Info
rmat
ion
Man
agem
ent M
atu
rity
Exchange of PI
between systems,
functions a/o
processes
Transition to
structured PI
Structured Product
Information (PI) as
an asset
Exchange of PI
between
organisations
Time
Global
interoperability
1
2
3
4
5
1. Structured Product Information as an asset
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Typical questions to be asked:
- Balance organizational, procedural, technological & information requirements?
- Real value of structured product information?
- Business strategy towards interoperability?
- Stakeholder perspectives?
- How to use enablers (RIMS, SCA, IDMP)?
Info
rmat
ion
Man
agem
ent M
atu
rity
1
Enterprise
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Info
rmat
ion
Man
agem
ent M
atu
rity
1
2
Typical questions to be asked:
- Which primary processes can be optimized using data instead of documents?
- What structured PI do we need for our operations?
- What does the transition mean for our organization?
- Which technologies do we need?
Departmental
2. Transition from document-based to data-based
operations
3. Exchange of structured product information between
systems, functions a/o processes
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Info
rmat
ion
Man
agem
ent M
atu
rity
1
2
3
Typical questions to be asked:
- What is our role as RA in the cross-functional process landscape?
- What are the (internal) customer needs?
- Efficiency gains?
Cross-
Departmental
4. Exchange of structured product information between
organisations
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Info
rmat
ion
Man
agem
ent M
atu
rity
1
2
3
4
Cross-
Company
Typical questions to be asked:
- How can I use this information?
- What does the transition mean for our company?
- What are the (external) customer needs?
- Which technologies do we need?
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Info
rmat
ion
Man
agem
ent M
atu
rity
1
2
3
4
5
Global
Typical questions to be asked:
- Future use cases and new organizational structures?
- Emerging / disruptive technologies (A.I., blockchain, etc.)
- Emerging rules & regulations, advances in medicines, politics, etc.
5. Global Interoperability
With each step business benefits are unlocked and
compliance improved
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Low Medium Medium High
Limited Functional Cross Functional Cross Industry
Single
Processes Functional Cross Functional Cross Industry
High Medium Medium Low
Processing
Efficiencies
Data Driven Informed
Decision making
Compliance
Oversight
Data Duplication
Info
rmat
ion
Man
agem
ent M
atu
rity
Time
1
2
3
4
5
A general positioning of the industry
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Adnan Jamil
Plotting agency initiatives helps us to understand
relationships, prerequisites and likely next steps
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Info
rmat
ion
Man
agem
ent M
atu
rity
Exchange of PI
between systems,
functions a/o
processes
Transition to
structured PI
Structured Product
Information (PI) as
an asset
Exchange of PI
between
organisations
Time
Global
interoperability
1
2
3
4
5
Telematics
MDM
roadmap
OMS / RMS Go-
live + Expansion
EMA initiatives plotted onto the maturity curve
eAF, CESSP,
Clinical Trial
Portal xEVMPD
reporting
SPOR
reporting
FMD reporting
E-Healthcare
EU SRS
Strategic
continuation of
SPOR during
relocation to
Amsterdam
SMS & PMS
Go-Live
Plotting our client initiatives on the same curve helps
to understand common gaps and advised next steps
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Info
rmat
ion
Man
agem
ent M
atu
rity
Exchange of PI
between systems,
functions a/o
processes
Transition to
structured PI
Structured Product
Information (PI) as
an asset
Exchange of PI
between
organisations
Time
Global
interoperability
1
2
3
4
5
Product Data
Governance xEVMPD/OMS/
RMS reporting
Iperion’s client initiatives plotted onto the maturity curve
ERP–RIMS
ScA implementation
RIMS
Implementation
CVM
CCMS–RIMS
Maturity
Assessment
FMD reporting
SPOR
reporting
Supplier
management
Majority of our clients
How Iperion can help your organisation
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Adnan Jamil
The model allows us to ask and answer the right
questions, and to put these into the right perspective
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POTI Assessment
2.
3.
1.
Maturity & Vision
Observations
Company A: Stage 1 maturity
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Advised focus
Willing to change
PI maintained in spreadsheets
Control, traceability and oversight
not automated
Core PI not embedded into
primary process
Data governance
Business critical data,
its availability and consistency
RIMS strengths and weaknesses
RIMS use starting with
business core processes
Roadmap +
detailed plan
Company B: Stage 2 maturity
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Observations Advised focus
Cross-functional data ownership,
reg. information broker
Use cases identification for
available information
RIMS and ScA implemented
After the fact information storage,
not utilized for core processes
Globalisation of organisational setup and
agreed procedures
Cross-functional information management
ERP-RIMS integration
End-to-end definition of RIM and
RA responsibilities
Key take-aways
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Rens van den Boomen
Key take-aways
• This is a marathon, not a sprint
• Understand your maturity and ambitions
• Always consider Process, Information, Technology and Organisation
• Find the right help
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Integrated Product Information Management
Providing the right people, with the right
information, in the right format, at the right
time, to make the right decision
Don’t miss our questionnaire!
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For more information visit our website at http://iperion.nl/webinar-series/
Online Questionnaire - Easy to fill in
- Just 10 questions to answer
- Provides you with an indication of your
organisation’s maturity
For more information visit our website at http://iperion.nl/webinar-series/
Questions & Answers
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Contact us, if you want to know more about: - RIMS
- ScA
- IDMP
- ERP-RIMS alignment
- Data Governance
For more information visit our website at http://iperion.nl/webinar-series/
About Iperion
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Reading Material
Iperion is a life sciences consulting and pharma IT
company, based in The Netherlands with a global focus
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http://iperion.nl/
RIM STRUCTURED
AUTHORING
IDMP QMS GXP CLOUD COMPUTING
Readiness Assessment
ISO IDMP Implementation
Project Management
IT Strategy and Information Architecture
ISO IDMP Training
Iperion is a life sciences consulting and pharma IT
company, based in The Netherlands with a global focus
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http://iperion.nl/
System, Data and Process Assessment
RIM STRUCTURED
AUTHORING
IDMP QMS GXP CLOUD COMPUTING
IT Strategy and Solution Architecture
RIM System Evaluation, Selection and Validation
RIM Data Strategy and Information Architecture
Regulatory Operational Excellence
RIM System and Business Integration
RIM Business and Quality Reporting
Iperion is a life sciences consulting and pharma IT
company, based in The Netherlands with a global focus
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http://iperion.nl/
RIM STRUCTURED
AUTHORING
IDMP QMS GXP CLOUD COMPUTING
Awareness and Training
Vendor Selection
Program Development, Setup and Execution
Strategy and Solution Architecture
Structured Authoring Implementation
Why our clients chose Iperion?
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Standardized RIMS maturity assessment
Rapid onboarding of relevant stakeholders
Focus on key RIM processes
Experienced data management professionals
Guidance via our extensive networks
Pragmatic, hands on & fit for purpose solutions
Accelerators
>>>
Our extended regulatory network keeps you informed
on all latest developments
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NEN / ISO
EMA
SPOR (IDMP) Taskforce
FDA
IDMP roundtable
Your business
IRISS
CBG / MEB
Industry Reps
Abbreviation List
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Abbreviation List (1/2)
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(x)EVMPD (Extended) Eudravigilance Medicinal Product Dictionary
AMP Authorised Medicinal Product
CAP Central Authorisation Procedure
CBG-MEB College Ter Beoordeling van Geneesmiddelen - Medicines Evaluation Board
CRO Contract Research Organisation
CESSP Common European Single Submission Portal
CT Site Clinical Trial Site
CTR Clinical Trial Regulation
CV Controlled Vocabulary
CVM Controlled Vocabulary Management
eAF Electronic Application Form
EMA European Medicines Agency
eQMS Electronic Quality Management System
ERP Enterprise Resource Planning
FDA Food and Drug Administration
FMD Falsified Medicines Directive
GDP Good Documentation Practice
GMP Good Manufacturing Practice
G-SRS Global-Substance Registration System
GVP Good Pharmacovigilance Practice
HL7 Health Level 7
IDMP Identification of Medicinal Product
IMP Investigational Medicinal Product
Abbreviation List (2/2)
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IRISS Implementation of Regulatory Submission Standards
ISO International Organisation for Standardization
MAA Marketing Authorisation Application
MAH Marketing Authorisation Holder
MDM Master Data Management
MedDRA Medical Dictionary for Regulatory Activities
MFG Manufacturing
NAP National Authorisation Procedure
NCA National Competent Authority
NEN Dutch Organization for Standardization
OMS Organisation Management Services
PMDA Pharmaceuticals and Medical Devices Authority (Japanese Competend Authority)
PMS Product Management Services
PV Pharmacovigilance
QP Qualifid Person
RA Regulatory Affairs
RIMS Regulatory Information Management System
SME Subject Matter Expert
SMS Substances Management Services
SOP Standard Operating Procedure
SPL Structured Product Labeling
SPOR Substances Products Organisations Referentials
Thank you for your attention!
IPERION® ▪ Consultancy ▪ Cloud computing ▪ Information systems
Guided by the slogan ‘systems and services that work for life sciences’, Iperion’s team of skilled professionals
is focused on the development, delivery and integration of systems and technology that help our life sciences
clients to innovate and improve business processes and supply chains.
Our clients are pharmaceutical, medical devices and biotech companies as well as organizations operating in
the healthcare and regulatory sector.
For more information about our organization, please visit iperion.nl.
© 2018 IPERION® All Rights Reserved.
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Contact information Address
www.iperion.nl
+31 73 6488000
Achterstraat 27
5251 CS Vlijmen
The Netherlands