Post on 06-Mar-2018
IDMP NOW OR LATER?
A pragmatic approach towards interoperability
November 15, 2017
Introductions and objectives
Confidential – IPERION® 2017 2
Lunyan Zhu
Confidential – IPERION® 2017 3
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
Confidential – IPERION® 2017 4
Five years of IDMP – Iperion’s lessons learnt
Confidential – IPERION® 2017 5
Frits Stulp
Agency plans for IDMP have been anything but
straightforward, making it a hard internal sell for our clients
Confidential – IPERION® 2017 6
Forced focus on relocation of EMA due to Brexit have
impacted virtually all European IDMP projects
Confidential – IPERION® 2017 7
What is the impact on your business and could IDMP
be used as a Brexit enabler?
Confidential – IPERION® 2017 8
Despite all perils, there is also a positive story to tell
Confidential – IPERION® 2017 9
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
Awareness Involvement Solutions Need
To
da
y
20
12
To
da
y
20
12
To
da
y
20
12
Inc
rea
se
To
da
y
20
12
Five years of IDMP have exposed underlying
challenges holding back the pharmaceutical industry
Confidential – IPERION® 2017 10
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
Time for a new perspective?
Confidential – IPERION® 2017 11
Rens van den Boomen
ISO IDMP introduces data models; Jigsaw puzzles that enable
standardisation of product information piece by piece
Confidential – IPERION® 2017 12
ISO IDMP is the only globally agreed standard that covers the entire gamut of medicinal product data
Standardizing product information allows us to make
our limited resources go further
Confidential – IPERION® 2017 13
Product information standardisation is a prerequisite for
interoperability across your processes, systems, functions, and
eventually the entire pharmaceutical industry
Achieving interoperability by standardisation is a
marathon and not a sprint
Confidential – IPERION® 2017 14
1. Structured Product Information (PI) as an asset…
Confidential – IPERION® 2017 15
2. Transition to high quality structured product
Information; The unstructured stage…
Confidential – IPERION® 2017 16
2. Transition to high quality structured product
Information; The structured stage…
Confidential – IPERION® 2017 17
3. Exchange of structured product information between
systems, functions a/o processes…
Confidential – IPERION® 2017 18
4. Exchange of structured product information between
organisations…
Confidential – IPERION® 2017 19
5. Global interoperability…
Confidential – IPERION® 2017 20
With increased interoperability business benefits are
unlocked and compliance improved
Confidential – IPERION® 2017 21
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”?
Confidential – IPERION® 2017 22
IDMP Now or Later?
Confidential – IPERION® 2017 23
Now
Later Frits Stulp
Allow the market to decide the real value of structured
product information and with it the fate of IDMP
Confidential – IPERION® 2017 24
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
Regulatory affairs as your cross functional broker of
high quality structured product information
Confidential – IPERION® 2017 25
Ensure your approach is value rather than compliance
driven and promotes interoperability
Confidential – IPERION® 2017 26
Use IDMP as an enabler for your value driven initiatives
and gradually build towards compliance
Confidential – IPERION® 2017 27
Build your own company specific value driven roadmap and
consider compliance as one of the deliverables
Confidential – IPERION® 2017 28
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
Confidential – IPERION® 2017 29
Upcoming Events
Confidential – IPERION® 2017 30
Lunyan Zhu
Don’t miss our white paper!
Confidential – IPERION® 2017 31
For more information visit our website at http://iperion.nl/webinar-series/
Don’t miss out on our next webinar!
Confidential – IPERION® 2017 32
For more information visit our website at http://iperion.nl/webinar-series/
Don’t miss out on our webinar series!
Confidential – IPERION® 2017 33
For more information visit our website at http://iperion.nl/webinar-series/
Questions & Answers
Confidential – IPERION® 2017 34
Frits Stulp
About Iperion
Confidential – IPERION® 2017 35
Reading Material
Iperion is a life sciences consulting and pharma IT
company, based in The Netherlands with a global focus
Confidential – IPERION® 2017 36
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
Why our clients chose Iperion?
Confidential – IPERION® 2017 37
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
Confidential – IPERION® 2017 38
NEN / ISO
EMA
SPOR (IDMP) Taskforce
FDA
IDMP roundtable
Your business
IRISS
CBG / MEB
Industry Reps
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.
Confidential – IPERION® 2017 39
Contact information Address
www.iperion.nl
contact@iperion.nl
+31 73 6488000
Achterstraat 27
5251 CS Vlijmen
The Netherlands