IDMP NOW OR LATER? - · PDF fileAgency plans for IDMP have been anything but...

IDMP NOW OR LATER?

A pragmatic approach towards interoperability

November 15, 2017

Introductions and objectives

Confidential – IPERION® 2017 2

Lunyan Zhu

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


Five years of IDMP – Iperion’s lessons learnt


Frits Stulp

Agency plans for IDMP have been anything but

straightforward, making it a hard internal sell for our clients


Forced focus on relocation of EMA due to Brexit have

impacted virtually all European IDMP projects


What is the impact on your business and could IDMP

be used as a Brexit enabler?


Despite all perils, there is also a positive story to tell


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

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Five years of IDMP have exposed underlying

challenges holding back the pharmaceutical industry


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?


Rens van den Boomen

ISO IDMP introduces data models; Jigsaw puzzles that enable

standardisation of product information piece by piece


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


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


1. Structured Product Information (PI) as an asset…


2. Transition to high quality structured product

Information; The unstructured stage…


2. Transition to high quality structured product

Information; The structured stage…


3. Exchange of structured product information between

systems, functions a/o processes…


4. Exchange of structured product information between

organisations…


5. Global interoperability…


With increased interoperability business benefits are

unlocked and compliance improved


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”?


IDMP Now or Later?


Now

Later Frits Stulp

Allow the market to decide the real value of structured

product information and with it the fate of IDMP


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


Ensure your approach is value rather than compliance

driven and promotes interoperability


Use IDMP as an enabler for your value driven initiatives

and gradually build towards compliance


Build your own company specific value driven roadmap and

consider compliance as one of the deliverables


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


Upcoming Events


Lunyan Zhu

Don’t miss our white paper!


For more information visit our website at http://iperion.nl/webinar-series/

http://iperion.nl/webinar-series/



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Questions & Answers


Frits Stulp

About Iperion


Reading Material

Iperion is a life sciences consulting and pharma IT

company, based in The Netherlands with a global focus


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

http://iperion.nl/

Why our clients chose Iperion?


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


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.


Contact information Address

www.iperion.nl

[email protected]

+31 73 6488000

Achterstraat 27

5251 CS Vlijmen

The Netherlands

http://www.iperion.nl/

mailto:[email protected]

https://twitter.com/IperionLSI

https://www.linkedin.com/company/571578/

IDMP NOW OR LATER? - · PDF fileAgency plans for IDMP have been anything but...

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