HOW TO OPTIMIZE THE USE OF YOUR RIM SYSTEM? - Iperion · How to optimize the use of your RIM system...

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

Confidential – IPERION® 2017 2

Lunyan Zhu

• M.Sc. Economics

• Consultant and Marketing Lead at Iperion Life Science Consultancy

Today’s Speaker: Frits Stulp


• 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


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!


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



Agenda




– About us



• Q&A

What is Regulatory Information Management or RIM?


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.


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


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


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


Structured

Authoring

Regulatory

MDM

ERP/RIMS

Integration

OMS/RMS IDMP

Industry trend shows various RIM discussions taking

place


Structured

Authoring Webinar 04

Regulatory

MDM Webinar 02

OMS/RMS Webinar 02

ERP/RIMS

Integration Webinar 03

IDMP Webinar 02


or RIMS?

Description:





RIMS

Compliance

& Reporting xEVMPD/SPL IDMP UDI

Quality

Reporting

Business

Reporting

Dossier

Management

Label


R&D

Documents

Management Content

Submission

Planning &

Tracking

Product

Lifecycle

Mgt.

HA

Interactions

Product

Release

Labeling &

Translation

Mgt.

Process

Data License

Information

Product


Controlled

Vocabularies

Example RIMS 1

Compliance

& Reporting


or RIMS?

Description:





RIMS

Compliance

& Reporting xEVMPD IDMP UDI

Quality

Reporting

Business

Reporting

Dossier

Management

Label


R&D

Documents

Management Content

Submission

Planning &

Tracking

Product

Lifecycle

Mgt.

HA

Interactions

Product

Release

Labeling &

Translation

Mgt.

Process

Data License

Information

Product


Controlled

Vocabularies

Example RIMS 2

Compliance

& Reporting

Observations made when working with our clients and

talking about their RIMS experiences


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


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


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


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


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


The (growing) role of RIMS in your organization


To achieve this, optimization of your RIMS is essential!

Iperion can help in optimizing your RIMS


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

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


Agenda




– About us



• Q&A

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

http://iperion.nl/




http://iperion.nl/

RIM STRUCTURED

AUTHORING


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



Agenda




– About us



• Q&A

Did you like this webinar?



Agenda




– About us



• Q&A

Don’t miss out on our next webinar!


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/

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Don’t miss out on our webinar series!


Upcoming webinars

Dates & times will be announced soon!

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





Agenda




– About us



• Q&A

Questions & Answers


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/

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HOW TO OPTIMIZE THE USE OF YOUR RIM SYSTEM? - Iperion · How to optimize the use of your RIM system...

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Transcript of HOW TO OPTIMIZE THE USE OF YOUR RIM SYSTEM? - Iperion · How to optimize the use of your RIM system...