WEBINAR #5 INTEGRATED PRODUCT INFORMATION … · Clinical Trial xEVMPD Portal reporting SPOR...

WEBINAR #5

INTEGRATED PRODUCT INFORMATION MANAGEMENT

A pragmatic approach towards interoperability

20 March, 2018

Introductions and objectives

Confidential – IPERION® 2018 2

Lunyan Zhu

Lunyan Zhu


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


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


Introducing the Maturity Matrix


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


To increase organisational effectiveness a fundamental

change of thinking is required


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


Integrated Product Information

Management

Implementing Integrated Product Information

Management is a marathon, not a sprint


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


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


Info

rmat

ion

Man

agem

ent M

atu

rity

1

2


- 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


Info

rmat

ion

Man

agem

ent M

atu

rity

1

2

3


- 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


Info

rmat

ion

Man

agem

ent M

atu

rity

1

2

3

4

Cross-

Company


- 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?


Info

rmat

ion

Man

agem

ent M

atu

rity

1

2

3

4

5

Global


- 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


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


Adnan Jamil

Plotting agency initiatives helps us to understand

relationships, prerequisites and likely next steps


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


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


Adnan Jamil

The model allows us to ask and answer the right

questions, and to put these into the right perspective


POTI Assessment

2.

3.

1.

Maturity & Vision

Observations

Company A: Stage 1 maturity


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


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


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


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!


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


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






Questions & Answers


Contact us, if you want to know more about: - RIMS

- ScA

- IDMP

- ERP-RIMS alignment

- Data Governance





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/




http://iperion.nl/

System, Data and Process Assessment

RIM STRUCTURED

AUTHORING


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

http://iperion.nl/




http://iperion.nl/

RIM STRUCTURED

AUTHORING


Awareness and Training

Vendor Selection

Program Development, Setup and Execution

Strategy and Solution Architecture

Structured Authoring Implementation

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

Abbreviation List


Abbreviation List (1/2)


(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)


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.


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/

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