Frits Stulp

Managing Director Iperion Life Sciences Consultancy

Samarind Webinar July 29th, 2015

IDMP update:

A practical approach to IDMP implementation and

the impact of the possible new phasing

Introduction

A practical approach to IDMP implementation

The building blocks:

Understanding the impact and recognizing the data

An example: Clinical particulars

Bringing IT together (IT Architecture)

Next steps and the impact of the possible revision in timing

Questions

CONTENTS

INTRODUCTION

Frits Stulp

M.Sc. In Pharmacochemistry

Worked for Yamanouchi / Astellas (1998 – 2007):

Responsible for development and maintenance of R&D Quality System

Manager of European SAP Competence Center / SAP Project Manager

Worked for Accenture (2007 – 2011):

Project manager for several projects in Healthcare and Life Sciences (a.o. Business Intelligence projects, compliance projects)

Independent project manager / advisor since 2011 as Mesa Arch Consulting:

Specialized in project management of IT projects for Regulatory Compliance

Project manager for XEVMPD compliance project for Astellas

Lead consultant and Program Manager for IDMP compliance at Astellas

IDMP SME and practical advisor to MAH’s and Regulatory / PV software suppliers

Active speaker on several IDMP conferences

Managing Director of Iperion Life Sciences Consultancy:

Specialized consulting in (regulatory) compliance in life sciences by applying IT tools (system-agnostic)

INTRODUCTION OF FRITS STULP

COMPANY PROFILE

DEDICATION TO LIFE SCIENCES

SOLUTION PROVIDER

DELIVERY

CHARACTERISTICS

Pharma/Biotech

Medical Devices

Contractors

Health Care

Information Systems

GxP Cloud Comp.

Consultancy

Reliable Solutions

Project Results

High Quality

Customer Satisfaction

CONSULTANCY

Regulatory Affairs (XEVMPD / IDMP)

Quality Management

Computer System Validation Services

IT Compliance & Audits

Consultancy services are based on content knowledge and not

specific or limited to any system or tool

IDMP is mandatory

Need to stay compliant to ensure products on the market

First focus on the EU, but keep in mind the global perspective

IDMP can bring additional benefits to the company

Global identifiers allow for improved communication and

understanding between regions and departments

IDMP

A practical approach to IDMP Implementation: - the building blocks:

Understanding the impact and recognizing the data

An example: Clinical particulars

Bringing IT together (IT Architecture)

IDMP

A DATA EXAMPLE

Manufacturer, the related Operation type and associated

Manufacturing Authorisation number

Where do you record this – in your RIMS, Production system, a

list?

Who is responsible – RA, Manufacturing or QA?

ANOTHER DATA EXAMPLE

Information on the included device with your product:

Like its material and physical characteristics

Where do you keep such data?

The product administered to a patient for treating or preventing disease

Example data: Combined Pharmaceutical Dose Form

Possible sources: Dossier, RIMS

12

Medicinal Product

Manu-facturer

Marketing Authori-zation

Packaged Medicinal Product

Pharma-ceutical Product

Clinical Particulars

Information on the manufacturer of the product Example data: Manufacturing License Number Possible sources : RIMS, ERP, Manufacturing information systems, Dossier

The registration and marketing of the product Example data: Marketing Date Possible sources : M&S affiliate, Dossier, RIMS

The Packaging of the product Example data: Image of the packaged product Possible sources : RIMS, ERP, Artwork systems, Manufacturing information systems

Data regarding the manufactured item. Usually this is equal to the Medicinal Product, but there are instances where the product undergoes an transformation before being administered Example data: Strenght of all ingredients

Information about indications, contra-indications, undesirable effects and interactions Example data: Intended Effect

MAPPING THE IDMP DATA TO SOURCES

Medicinal Product

Manufacturer

Marketing Authorization

Packaged Medicinal

Product

Pharma-ceuticalProduct

Clinical Particulars

13

Pharma-ceutical Product

Clinical Particulars

Data regarding the manufactured item. Often equal to the Medicinal Product, but product can undergo transformation before being administered Example data: Strength of all ingredients Possible sources: Dossier, RIMS, ERP

Information about indications, contra-indications, undesirable effects and interactions Example data: Intended Effect Possible sources : Dossier, RIMS, Product Information (Systems), SmPC, SPL, Drug safety systems

Substances

Supporting details of substances used Example data: Molecular weight Possible sources : Dossier, RIMS, ERP, SRS ?

MAPPING THE IDMP DATA TO SOURCES

Medicinal Product

Manufacturer

Marketing Authorization

Packaged Medicinal

Product

Pharma-ceuticalProduct

Clinical Particulars

Finding the sources and the impact of IDMP on

your environment:

Find where this data is stored (system, paper, etc.)

Determine specifics for products in scope (devices, biologicals, etc.)

Determine consistency of this information across the globe

Understand the processes & procedures that ensure this data is kept up

to date:

With the up to date regulatory information

With the practice applied in the plant (a.o.)

View the organizational impacts of IDMP

In other words: Do a readiness assessment

UNDERSTANDING IDMP IMPACT

TYPICAL AREAS OF

YOUR ASSESSMENT (1/2)

Regulatory scope

Number of dossiers

Legacy of National Products

eCTD vs pre-eCTD

Global or regional company

Number of license partners and M&A’s

Medical devices in portfolio

Biologicals on the market

Current compliance XEVMPD compliant

SPL compliant

UDI prepared / compliant

Supply chain and manufacturing scope Number of plants

In-house vs contract Manufacturing

TYPICAL AREAS OF

YOUR ASSESSMENT (2/2)

Process maturity

All processes described

Process orientation vs functional (silo) orientation

Procedural arrangements with third parties (e.g. Master data exchange)

IT & architecture Infrastructure for master data mgt

Integration level for applications, like Enterprise service bus and datawarehousing

ERP policy (single instance vs multiple)

Gateway management in place

Labelling solution in place

Organizational readiness

Coverage and detail level of procedures

Establish impact on current roles

Change readiness of involved functions

Some key-factors

can be recognized

that strongly drive

the complexity of

your IDMP

challenge, for

example:

WHAT DRIVES THE OUTCOME?

Decreases complexity

Increases complexity

The outcomes allow you to make your plan and set priorities, naturally, aligned with exernal deadlines and phases.

A practical approach to IDMP Implementation: - the building blocks:

Understanding the impact and recognizing the data

An example: Clinical particulars

Bringing IT together (IT Architecture)

Clinical particulars:

Typically coming from the Product Information documents like

the Summary of Product Characteristics

MedDRA coding is needed when submitting the IDMP records

Although identified in the new phasing as Iteration 3, this

information can have major impact on patient safety and label

consistency

Let’s have a look at some of the fields and where to find them

Then we will see how we can manage this in the SPC and the

IDMP submission at the same time..

AN EXAMPLE

CLINICAL PARTICULARS

IDMP

Clinical Particulars: high level

IDMP

Clinical Particulars: Example

IDMP

Clinical Particulars: Example

IDMP

Clinical Particulars: Example

Coded in MedDRA

PI STRUCTURED AUTHORING

‘Master’ text

‘Instance’ text

‘QRD’ template

PI STRUCTURED AUTHORING

Getting the clinical particulars directly from the SPC

1. Select Clinical Particular(s)

2. Assign Code, via code list

Then clinical particulars can be delivered

as part of the IDMP submission

A practical approach to IDMP Implementation: - the building blocks:

Understanding the impact and recognizing the data

An example: Clinical particulars

Bringing IT together (IT Architecture)

OPTIONS FOR IDMP ARCHITECTURE

Dependent on where your IDMP data is, you can design

your IT architecture, like:

Expand your IDMP data in your RIMS and/or

Manage your source documents (like SPCs)

Bring the data together from the sources

Ensure common terms (= Master data mgt)

And then allow for approval, XML/SPL creation and submission

This can be achieved in all 4 scenarios

IT ARCHITECTURE

NEXT STEPS AND THE IMPACT OF

POSSIBLE REVISION IN TIMING

The official implementation date of 1 July 2016 for the full IDMP

scope is recognized as nearly impossible to achieve

A phased approach to implementation is proposed in which:

Phase 1: limited scope (XEVMPD, substances, mandatory items to

create IDMP identifiers)

Phase 2: scope extended with Investigational Medicinal Products

(development products)

Phase 3: include Clinical Particular details

Phase 4: include batch identifiers, alignment serialization and other

remaining IDMP items

Phase 5: include veterinary products

With initial timelines proposed for late 2017 and later phased up to

2019

HIGH LEVEL FEEDBACK FROM

EMA INFORMATION DAY

ANALYSIS OF ITERATIONS

Iteration 1

Iteration 4

Iteration 4

Iteration 3

Iteration 2

IMPID HIGH LEVEL DATA MODEL

So, the EU ISO IDMP Taskforce has formulated a

phasing plan that:

Is more realistic

Has buy-in from key stakeholders

EMA, NCA’s, Industry, Standardization organizations

But requires approval of the European Commission..

In other words: Be prepared to adjust your IDMP plans to a longer term phasing that fits into your

other RA IT plans

Make sure you can reach this timeline

NEXT STEPS

IDMP is a complicated area and although phasing is being discussed at this

time, you will still need to organize yourself to deal with this by:

Understanding your IDMP Readiness

Incorporating Business and IT alignment in your project

Plan the required project activities, taking relevant phasing and internal

developments into account

Stay tuned to the possible change of timing and take ownership of your

IDMP compliance

There are accelerators out there to help you like:

Project experience, Program templates, Process insights

Let me know if you have any questions!

CLOSING

Contact: Frits Stulp

Managing Director Consultancy

Iperion Life Sciences Consultancy

Phone: +31(0)652727351

Email: Frits.Stulp@iperion.nl

Website: www.iperion.nl

LinkedIn: http://www.linkedin.com/pub/frits-stulp/1/aa7/b7b