Third IDMP CEE workshop: IDMP CEE Communications by Gergana Majercakova
IDMP NOW OR LATER? - · PDF fileAgency plans for IDMP have been anything but...
Transcript of IDMP NOW OR LATER? - · PDF fileAgency plans for IDMP have been anything but...
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IDMP NOW OR LATER?
A pragmatic approach towards interoperability
November 15, 2017
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Introductions and objectives
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Lunyan Zhu
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Confidential – IPERION® 2017 3
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Objectives of today’s webinar
• To share our lessons learnt of 5 years of IDMP
• To position structured product information into a different perspective
• To share tangible business benefit examples of structured product
information
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Five years of IDMP – Iperion’s lessons learnt
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Frits Stulp
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Agency plans for IDMP have been anything but
straightforward, making it a hard internal sell for our clients
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Forced focus on relocation of EMA due to Brexit have
impacted virtually all European IDMP projects
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What is the impact on your business and could IDMP
be used as a Brexit enabler?
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Despite all perils, there is also a positive story to tell
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Since the beginning in 2012:
Shifted awareness in the industry on the role of (RA) and structured product data
Increased involvement of industry, authorities, vendors and interest groups
Increase in commercially available solutions
The need, urgency and benefits of structured product information is still present
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Five years of IDMP have exposed underlying
challenges holding back the pharmaceutical industry
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Key underlying challenges for industry:
1. Structured product information is not
(yet) considered a key business asset on
executive level
2. Due to high profit margins the incentive
to reduce product approval lead times
and process inefficiencies remains low
3. Traditional ways of silo’ed working are an
obstacle to overcome when evolving
towards a data value driven industry
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Time for a new perspective?
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Rens van den Boomen
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ISO IDMP introduces data models; Jigsaw puzzles that enable
standardisation of product information piece by piece
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ISO IDMP is the only globally agreed standard that covers the entire gamut of medicinal product data
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Standardizing product information allows us to make
our limited resources go further
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Product information standardisation is a prerequisite for
interoperability across your processes, systems, functions, and
eventually the entire pharmaceutical industry
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Achieving interoperability by standardisation is a
marathon and not a sprint
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1. Structured Product Information (PI) as an asset…
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2. Transition to high quality structured product
Information; The unstructured stage…
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2. Transition to high quality structured product
Information; The structured stage…
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3. Exchange of structured product information between
systems, functions a/o processes…
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4. Exchange of structured product information between
organisations…
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5. Global interoperability…
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With increased interoperability business benefits are
unlocked and compliance improved
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Consider today an opportunity to redefine your IDMP
initiative to make it value rather than compliance driven
Questions you might ask yourself and your sponsors:
• Which underlying business problems did our current project reveal to-date?
• Do our sponsors and executives really understand what we are trying to
achieve? What the benefits are and what the risks when not achieved?
• Is structured product information considered a key business asset in our
organisation?
• What are our business drivers that justify investing heavily in structured
product information?
• Which functions, systems and processes would benefit from structured
product information?
• Can this initiative positively impact our day-to-day operations?
• Can we reduce complexity by converting it into value driven “bite-sized
chunks”?
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IDMP Now or Later?
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Now
Later Frits Stulp
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Allow the market to decide the real value of structured
product information and with it the fate of IDMP
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Key business advantages of structured product information:
1. Higher profit margins due to reduced product approval lead
times and removal of process inefficiencies
2. Brand protection due to end-to-end control over product
information used to execute your supply chains and information
shared with patients and healthcare professionals
3. Structured product information to facilitate data driven informed
decision making on strategic and operational levels
4. Bridge the gaps between organisational silo’s towards a data
value driven industry
5. Key stepping stone toward global interoperability
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Regulatory affairs as your cross functional broker of
high quality structured product information
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Ensure your approach is value rather than compliance
driven and promotes interoperability
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Use IDMP as an enabler for your value driven initiatives
and gradually build towards compliance
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Build your own company specific value driven roadmap and
consider compliance as one of the deliverables
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Key take-aways
• Structured product information should be considered a key business
asset on executive level
• Standardizing product information allows us to make our limited
resources go further
• Achieving interoperability is a marathon, not a sprint
• Let the market decide what the value of structured product
information is
• Regulatory affairs as your cross functional broker of product
information
• Ensure your approach is value driven; Use IDMP as an enabler
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Upcoming Events
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Lunyan Zhu
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Don’t miss our white paper!
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For more information visit our website at http://iperion.nl/webinar-series/
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Don’t miss out on our next webinar!
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For more information visit our website at http://iperion.nl/webinar-series/
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Don’t miss out on our webinar series!
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For more information visit our website at http://iperion.nl/webinar-series/
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Questions & Answers
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Frits Stulp
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About Iperion
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Reading Material
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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
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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
>>>
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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
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Thank you for your attention!
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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
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+31 73 6488000
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