how to optimize the use of your rim system? - iperion · how to optimize the use of your rim system...
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HOW TO OPTIMIZE THE USE OF YOUR RIM SYSTEM?
Our experiences with RIMS business implementations
17th October
Welcome to our webinar!
Topics that will be covered today
Recent EMA events within the IDMP arena
What is RIM(S)?
RIM-related trends at the regulators and in industry
How to optimize the use of your RIM system
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Lunyan Zhu
• M.Sc. Economics
• Consultant and Marketing Lead at Iperion Life Science Consultancy
Today’s Speaker: Frits Stulp
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• M.Sc. In Pharmacochemistry
• Managing Director at Iperion Life Science Consultancy
• IRISS IDMP Topic Group Lead
• IDMP SME and trusted client program advisor for several IDMP
initiatives
• Active speaker on IDMP and regulatory conferences
• Project manager in IT projects for Reg. Compliance, Business
Intelligence related to IDMP/XEVMPD
Over 15 years of experience within the Life Sciences Industry
Worked for several Regulatory / PV software suppliers
IDMP SME / Practical advisor / lead consultant / project manager
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Agenda
• Iperion’s perspective on current IDMP environment
• RIMS business implementations – Experiences & lessons learned
• Want to know more?
– About us
– About the case study
– About the next webinars
• Q&A
Iperion’s perspective on recent EMA events* within the
IDMP arena
• Transitioning from paper driven to data driven operations on such a scale is
difficult and is a big change!
• Challenges of a paper driven industry were exposed by IDMP and still
remain
• More importantly, the challenges are neither defendable nor sustainable in the
new data driven era we call the 21st century
• Other industries have already undergone this transition
• Data driven operations are key for
• Effective pharmacovigilance and benefit-risk assessments
• Increased speed of regulatory review
• Efficient inter- and intra-company communication
• Research & development
*Latest timelines (e.g. EMA SPOR, FDA PQ CMC) will be presented and discussed during our next webinar!
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Agenda
• Iperion’s perspective on current IDMP environment
• RIMS business implementations – Experiences & lessons learned
• Want to know more?
– About us
– About the case study
– About the next webinars
• Q&A
What is a Regulatory Information Management System
or RIMS?
Description:
RIMS is a system that facilitates and supports business processes for
the collection, organization (planning), storage and communication of
regulatory information.
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RIMS
Compliance
& Reporting xEVMPD / SPL IDMP UDI
Quality
Reporting
Business
Reporting
Dossier
Management
Label
Management Publishing Reg. Archive
R&D
Documents
Management Content
Submission
Planning &
Tracking
Product
Lifecycle
Mgt.
HA
Interactions
Product
Release
Labeling &
Translation
Mgt.
Process
Data License
Information
Product
Information Organizations Substances
Controlled
Vocabularies
Typical Functionalities of current RIMS
Compliance
& Reporting
A business integrated RIMS should facilitate business
process and better informed decision making
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1. Golden source of structured regulatory information
2. Enables reporting on business critical information
3. Facilitates planning of (regulatory) activities
4. Maximizes efficiency of resources
1. Golden source of structured regulatory information
2. Enables reporting on business critical information
3. Facilitates planning of (regulatory) activities
4. Maximizes efficiency of resources
Improved Decision Making PV
MFG
Clin
RA
QA
We also see RIM-related trends at regulators and in industry
Regulatory trend shows increased regulations, scrutiny
and complexity
• Inspections with regulatory focus and
pre-informed inspectors
• Global communication and
transparency requests
• Requirement for data submission
formats
• IDMP, CDISC, PQ CMC, etc.
• Legislation
• Clinical Trials, SPOR, Falsified
Medicines
• Benefit/Risk assessments
• Fulfilling Commitments
• Referrals
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What are the consequences for RA?
Diminished silo boundaries, to increase effective
collaboration across the lifecycle
New technological possibilities enable integrated cross-
functional information management allowing business
to cope with external and internal requirements
Transparency pushes need for consistent PI in public
domain and increased oversight of contractors/3rd
parties
Increased complexity in working environment results in
workload, resource, budget increases
Efficiency drives for offshoring/outsourcing routine
tasks
Industry trend shows various RIM discussions taking
place
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Structured
Authoring
Regulatory
MDM
ERP/RIMS
Integration
OMS/RMS IDMP
Industry trend shows various RIM discussions taking
place
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Structured
Authoring Webinar 04
Regulatory
MDM Webinar 02
OMS/RMS Webinar 02
ERP/RIMS
Integration Webinar 03
IDMP Webinar 02
What is a Regulatory Information Management System
or RIMS?
Description:
RIMS is a system that facilitates and supports business processes for
the collection, organization (planning), storage and communication of
regulatory information.
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RIMS
Compliance
& Reporting xEVMPD/SPL IDMP UDI
Quality
Reporting
Business
Reporting
Dossier
Management
Label
Management Publishing Reg. Archive
R&D
Documents
Management Content
Submission
Planning &
Tracking
Product
Lifecycle
Mgt.
HA
Interactions
Product
Release
Labeling &
Translation
Mgt.
Process
Data License
Information
Product
Information Organizations Substances
Controlled
Vocabularies
Example RIMS 1
Compliance
& Reporting
What is a Regulatory Information Management System
or RIMS?
Description:
RIMS is a system that facilitates and supports business processes for
the collection, organization (planning), storage and communication of
regulatory information.
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RIMS
Compliance
& Reporting xEVMPD IDMP UDI
Quality
Reporting
Business
Reporting
Dossier
Management
Label
Management Publishing Reg. Archive
R&D
Documents
Management Content
Submission
Planning &
Tracking
Product
Lifecycle
Mgt.
HA
Interactions
Product
Release
Labeling &
Translation
Mgt.
Process
Data License
Information
Product
Information Organizations Substances
Controlled
Vocabularies
Example RIMS 2
Compliance
& Reporting
Observations made when working with our clients and
talking about their RIMS experiences
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Clients
RIMS capabilities not
extensively used and
weaknesses not properly
managed
Information
Process
Organization
Technology
RIMS not perceived by the
business as source of truth
for regulatory information
RIMS does not support
business processes but is
used solely as tracking tool
and repository
RIMS is not facilitating
functions within the
organisation
Iperion proposes four basic improvements to start
optimizing the usage of your RIM System
Information: Ensure high quality and consistent data is
available at all times
Process: Use RIMS to facilitate business processes, starting
with your core processes
Organization: Serve your internal and external customers
Technology: Utilize system strengths and proactively manage its
weaknesses
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1. Information – Ensure high quality, consistent
and reliable data is available at all times
Key deliverables:
• Business glossary created
• Data standards and business rules defined
• Data cleansed, enriched and restructured conform data standards
• Processes to maintain data according to defined rules and standards
implemented
• Data quality reporting set up and implemented
Benefits:
• Solid foundation for proper information management
• Information as facilitator of informed decision making
• Higher adoption and satisfaction rates; RIMS’s image is that of a trustful source of regulatory and product information
• Fundamental groundwork for any future Master Data Management (MDM)
/data interoperability initiatives
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2. Process – Use RIMS to facilitate business
processes, starting with your core processes
Key deliverables:
• Maintenance of core product and license information established
• Variation and renewal tracking process established
• Regulatory data submission process established
• Business and quality reporting processes established
• Other processes established (e.g. tracking of periodic reporting,
commitments, Q&A, etc.)
Benefits:
• The right information is available at the right time allowing for doing it right
the first time
• Process efficiency
• Avoid rework (publishing, manufacturing change, label change)
• Improved process oversight and control
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3. Organization – Collaborate with and facilitate your
internal and external customers
Key deliverables:
• Key suppliers and consumers of information identified
• Data governance set up
• Communication and information flow across functions
optimized
Benefits:
• RA as custodian of structured regulatory PI &
Regulatory Compliance
• RIMS data governance as a step towards MDM
• Increased focus on internal customers (as it should be)
• Diminished silo boundaries
• Increased operational efficiency
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PV
MFG
Clin
RA
QA
4. Technology – Understand and utilize your system
strengths and proactively manage its weaknesses
Current system weaknesses:
• System work flows
• Investigational medicinal product information management
• Business and quality reporting
Current system strengths not utilized:
• Management of complex information (e.g. packaging hierarchy)
• Product lifecycle tracking (e.g. relating data changes to submissions and
included documents)
As an agnostic RIMS system integrator:
• We start from our extensive experience in regulatory business processes
• We advise based on system strengths and weaknesses, in comparison with
the organizational needs
• We influence technology development, to meet industry and regulator needs
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The (growing) role of RIMS in your organization
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To achieve this, optimization of your RIMS is essential!
Iperion can help in optimizing your RIMS
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For more information visit our website at http://iperion.nl
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Agenda
• Iperion’s perspective on current IDMP environment
• RIMS business implementations – Experiences & lessons learned
• Want to know more?
– About us
– About the case study
– About the next webinars
• Q&A
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
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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Agenda
• Iperion’s perspective on current IDMP environment
• RIMS business implementations – Experiences & lessons learned
• Want to know more?
– About us
– About the case study
– About the next webinars
• Q&A
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Agenda
• Iperion’s perspective on current IDMP environment
• RIMS business implementations – Experiences & lessons learned
• Want to know more?
– About us
– About the case study
– About the next webinars
• Q&A
Don’t miss out on our next webinar!
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IDMP now or later?
Date: 15 November, 2017
Time: 10-11 AM (CET) & 5-6 PM (CET)
For more information visit our website at http://iperion.nl/webinar-series/
Don’t miss out on our webinar series!
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Upcoming webinars
Dates & times will be announced soon!
For more information visit our website at http://iperion.nl/webinar-series/
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Agenda
• Iperion’s perspective on current IDMP environment
• RIMS business implementations – Experiences & lessons learned
• Want to know more?
– About us
– About the case study
– About the next webinars
• Q&A
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.
© 2017 IPERION® All Rights Reserved.
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Contact information Address
www.iperion.nl
+31 73 6488000
Achterstraat 27
5251 CS Vlijmen
The Netherlands