Schlaps_Final

IT-Consulting

Life Science

From the IDMP Readiness Assessment and Gap Analysis to the selection of an IDMP Solution Architecture

Dr. Dieter Schlaps

IT-Consulting Life Science

1

Introduction

What is IDMP?

The ISO standards that represent IDMP

The IDMP data submodels and their

Interrelationships

Onboarding of Stakeholders

Identification of Stakeholders

Creating Stakeholder Awareness about the

Upcoming IDMP Standard

Agenda

2D.Schlaps; From IDMP Readyness Assessment...

What is IDMP*?

• Next wave in the pharmacovigilance legislation after xEVMPD

• Requiring data integration from the entire company

• The five ISO standards referred to as "ISO IDMP" were

approved in 2012

• Has a global scope and in Europe / US it will take effect by

2016.

* Identification of Medicinal Products


Goals of IDMP

• Clear mapping of international terminologies (Routes of administration, dosage forms, etc.) for accurate analysis and comparison

• Cross-border identifiability of medicinal products despite of different naming conventions

• Identifiability of all product’s component substances (not only those that are contained in a given safety report)

• Support the activities of medicines regulatory agencies worldwide (development, registration, life cycle management, pharmacovigilance and risk management)


The five ISO standards

ISO11615:2012 Health Informatics – Identification of medicinal products – Data elements and

structures for the unique identification and exchange of regulated medicinal product information

ISO11616:2012 Health informatics – Identification of medicinal products – Data elements and

structures for the unique identification and exchange of regulated pharmaceutical product

information

ISO11238:2012 Health Informatics — Identification of medicinal products – Data elements and

structures for the unique identification and exchange of regulated information on substances

ISO11239:2012 Health Informatics — Identification of medicinal products — Data elements

and structures for the unique identification and exchange of regulated information on

pharmaceutical dose forms, units of presentation, routes of administration and packaging

ISO11240:2012 Health informatics — Identification of medicinal products – Data elements and

structures for the unique identification and exchange of units of measurement


Implementation Guidelines for the ISO

standards have had 2-month Ballots now

prCEN ISO/DTS 20443 Health Informatics – Identification of medicinal products – Implementation Guide

for ISO 11615 for data elements and structures for the unique identification and exchange of regulated

medicinal product information

prCEN ISO/DTS 20451 Health informatics – Identification of medicinal products – Implementation Guide

for ISO 11616 for data elements and structures for the unique identification and exchange of regulated

pharmaceutical product information

prCEN ISO/DTS 19844 Health Informatics — Identification of medicinal products – Implementation Guide

for ISO 11238 for Data Elements and Structures for the Unique Identification and Exchange of Regulated

Information on Substances

prCEN ISO/DTS 20440 Health Informatics — Identification of medicinal products — Implementation

Guide for ISO 11239 for Data elements and structures for the unique identification and exchange of

regulated information on pharmaceutical dose forms, units of presentation, routes of administration and

packaging

No Implementation Guide for ISO 11240:2012: Unified Code for Units of Measure (UCUM) will be used


IDMP at a Glance


Identifiers and Terminologies

Slide Courtesy of Sabine Brosch, EMA (modified)

Terminology

Concepts

Packaging

Measurement Units

Dose Forms

Routes of

Administration

Presentation Units

By Jurisdiction

Across

Jurisdictions

Across

Jurisdictions

By Jurisdiction

By Jurisdiction

Across

Jurisdictions

Medicinal Product + Identifier

(MPID)

Substance/

Specified

Substance

+ Identifier

(SID & SSID)

Package + Identifier

(PCID)

Batch + Identifier

(BAID)


PhPID – MPID

Japan

Branded

Product

A

MPID 1

USA

Branded

Product

B

MPID 2

France

Branded

Generic

C

MPID 3

France

Generic

D

MPID 4

Germany

Generic

E

MPID 5

Germany

Generic

F

MPID 6

Canada

Branded

Product

G

MPID 7

Common

PhPID

Set


10

MPID 1

PhPID 1

MPID 2

MPID 3

MPID 4D.Schlaps; From IDMP Readyness Assessment...

MPID High Level Model


Introduction

What is IDMP?

The ISO standards that represent IDMP

The Medicinal Product according to IDMP

Onboarding of Stakeholders

Identification of Stakeholders

Creating Stakeholder Awareness about the

Upcoming IDMP Standard

Agenda


Why Six-Sigma-based Approach?

• Six Sigma is a systematic methodology

that utilizes information (management

by facts) and statistical analysis to

measure and improve a company’s

operational performance, practices and

systems by identifying and preventing

‘DEFECTS’ in business processes.

• It is a way of thinking about processes

where the focus is on proactive control

of process inputs rather than reactive

look at process outputs


14

6Sigma Methodology - DMAIC

D.Schlaps; From IDMP Readyness Assessment...

The Define/Measure phase is

crucial to the project's success

Activities

Define the problem, the

goal, and the process

Analyze stakeholders

Evaluate the performance of

the current process

Identify causes of poor

performance

Deliverables

Project charter and project plan

Business case

High-level (SIPOC) and detailed process

map

Customer requirements

Stakeholder Analysis

Long list of potential root causes

Data collection plan

Baseline performance

Quick wins

ControlImproveAnalyzeDefine/

Measure


The Define phase

Develop the Business Case

Translate the Voice of the Customer

High-level map the process

Create a Project Charter


17

SIPOC: High Level Process Mapping

SIPOC is a high-level process map identifying the Suppliers, Inputs,

Process Steps, Outputs, and Customers involved in the project

The aim of a high-level process map is to identify the process boundaries

for the project (start/stop) and create a common understanding

The process map is created starting from the customers of the process and

the outputs that they are demanding. Thereby, the SIPOC map provides a first

overview of customers

A SIPOC map should be high-level containing about 5-8 process steps

Customer

ProcessInput Output

Supplier

D.Schlaps; From IDMP Readyness Assessment...

Creating a SIPOC according to

the Snake method

Process:

S I P O CSuppliers Inputs Process Outputs Customers

Sta

rt b

ou

nd

ary

Sto

p b

ou

nd

ary

The List method considers the link between Suppliers and Inputs and Outputs

and Customers, respectively.

Using the Snake method you take into account that the Output / Customer of a

specific process step can be an Input / Supplier for the following process step. 18D.Schlaps; From IDMP Readyness Assessment...

Application of SIPOC Charts to identify

roles and responsibilities in IDMP

a.) New Product Scenario

Who creates IDMP- relevant data in which stage (Draft, Final, Official) when and

for whom:

Identification of stakeholders

Identification of deliverables

Collection of „Critical- to-Quality“ Factors and high-level Business Requirements

Identification of source systems

SIPOC

b.) Product Maintenance/ Change Scenario


New Product

SIPOC Example (1)Process:


Global Project

Management, Regulatory

Management Responsible

Feasibility Study

Global Project



Project Plan and Budget

Global Project



Definition of Project Characteristics

Regulatory Management

ResponsibleDevelopment application strategy


ResponsibleScientific/ Regulatory Advice

? Decision for New Application


ResponsibleCommunicate deadline and scope

Regulatory

Submissin

Mgr

Submitting Unit

ResponsibleCompile project plan

Reg. Subm.

Authors and

various actors

Submitting Unit

Responsible

Communicate PP and request

documents

Requested documentation,

timelines

Various

actors,

External

providers

Various actors, External

providers

requested

documentationCreate/ provide documents M1-M5 documents

Submitting

Unit

Responsible

Submitting Unit

ResponsibleM1-M5 documents

Check completeness and plausibility

on single-document level

Flagged documents with

comments

Various

actors,

External

providers

Submitting Unit

ResponsibleM1-M5 documents

Check-in documents, dossier

compilationAccepted docs in DMS

Submitting Unit

Responsible

Accepted cosuments

in DMS, Dossier

(parts)

Check completeness, carry out gap

analysis and plausibility on single-

document level

Gap analysis,

complete dossier

Regulatory

Management

Responsible


ResponsibleCompleted dossier

Carry out publishing and technical

validationValidated package

Submitting

Unit

Responsible

Submitting Unit

Responsible

Finalized and

validated packageSubmit package to HA Electronic Submission HA

Submitting Unit

Responsible

Finalized and

validated package

Request (corr.) translation of product

informationProduct Information Various actors

Various actors Product Information Translate/correct Product InformationTranslated product

information

Submitting

Unit

Responsible

(Local/

Maintenance)

Submitting Unit

Responsible (Local

Affiliate/ Maintenance)

Translated Product

Information

Check translation of product

information

Revised/ corrected product

informationVarious actors

Submitting Unit

Responsible (Local

Affiliate/ Maintenance)

Corrected Product

Information

Finalize National Product Information

and submit package to National HA

Final National Product

InformationNational HA

Submitting Unit

ResponsibleTrack application status

Submitting Unit

ResponsibleDeficiency Letter Receive and analyze Deficiency letter

Submitting Unit

ResponsibleRequest response (with deadline)

Various internal/ external

authors

Various internal/ external

authorsinformation request Create/ rework response documents Submitting Unit Responsible

Submitting Unit

Responsibleresponse document

Check completeness and plausibility

on single-document level

Flagged document with

comments

Various

actors,

External

providers

Submitting Unit

Responsible

Corrected response

document

(If needed:) Compile and submit draft

responseDraft response HA


Responsible

Corrected response

document

(If needed:) Publishing and technical

validationValidated package

Submitting

Unit

Responsible

Submitting Unit

ResponsibleValidated package

(If needed:) Complete and submit

packageValidated package HA

Submitting Unit

Responsible

Deadlines, tracking

dataUpdated tracking data

New Product

Subm

issio

n t

o H

A o

f appro

ved p

ackage w

ith p

relim

inary

transla

tion o

f pro

duct

info

rmation

Subm

issio

n o

f finaliz

ed N

ational P

roduct

Info

rmation

Pro

ject

Pro

posal

Decis

ion f

or

New

Applic

ation

Subm

issio

n t

o H

A

Decis

ion f

or

New

Applic

ation

Subm

issio

n t

o H

A

HA

Accepta

nce

20

NewProduct_02.xlsx

NewProduct_02.xlsx

Product Maintenance and Change

SIPOC Template (2)Process:


Management of post-approval

commitments

Conduct of post-approval studies

and patient-related activities

Provision of product information

for Healthcare Professionals,

public and patients

Regulatory management of

marketed products and regulatory

life cycle managementSafety management of marketed

products and life cycle

managementProduct Quality Management

Production and Production

Change Management

Decision to carry out a variation

for the envisaged change

Prepare modified documentation

and justification

Prepare and submit updated

information to HA

Negotiation and approval of

requested changes

Execution of approved changes

(label translation, release of new

BOM, etc.)

Ma

rke

t L

au

nc

h

Te

rmin

ati

on

of

Ma

rke

t S

up

ply

IDMP Data

Product Maintenance


Stakeholder Analysis:

Perceived Challenges, Benefits, Prerequisites and

Requirements

Your feedback

Potential Challenges Potential Benefits

Essential

Prerequisites

Perceived

Requirements


Feedback.vsdx

Feedback.vsdx

The Measure/ Analyze phases

Identify potential causes

Develop a data collection plan

Verify the measurement system

Identify patterns in data

Determine baseline process capability

Count

Percent

C4Count

32.4 9.7 6.8 5.3 2.4

Cum % 43.5 75.8 85.5 92.3

90

97.6 100.0

67 20 14 11 5

Percent 43.5

OtherAEGBC

200

150

100

50

0

100

80

60

40

20

0

Cpk=0.36

Yield=86.2%

Process

Sigma=2.6

Prioritize potential causes


The Gap Analysis

Understanding the IDMP Data Requirements

Creating a Data Collection Plan

Verifying the Data Collection Approach with

Selected Products

Defining the Selection Strategy

Manual Collection of IDMP Data

Revisiting the Critical-to-Quality Factors

Agenda


IDMP Data

Model

25

Closer look at the IDMP data, where it is originating from

and where it is used


IDMP_DATA_ACQU_PLAN.xlsx

IDMP_DATA_ACQU_PLAN.xlsx

Example Results


Example:

Outcomes from Define phase

As-Is Process to acquire IDMP Data:

- Only a few databases are relevant for IDMP; many data is only

contained in documents

- Substance data not available in the (Generics) company

- Regulatory Affairs, Drug Safety, Medical Affairs, Supply Chain

and Affiliates are the main stakeholders to be involved

- IDMP data acquisition tests are necessary because of product

variabilities

- XML data structure to be used for the data acquisition process


The Gap Analysis

Understanding the IDMP Data Requirements

Creating a Data Collection Plan

Verifying the Data Collection Approach with

Selected Products

Defining the Selection Strategy

Manual Collection of IDMP Data

Revisiting the Critical-to-Quality Factors

Agenda


Selection Criteria for Products to be included in

IDMP Sample RunP1 P2 P3 P4 P5 P6 P7 P8 P9 P10

Medicinal Product Variations

Combination Product

Single Strength

Multiple Strengths

Manufacturer

Single Manufacturer

Multiple Manufacturers with different manufacturing tasks

Production

Internally produced

Externally produced

Marketing

Marketed by Internals

Marketed externally

Packaged Medicinal Product

Tablets

Liquid

Gel/ Cream

Aseptical Preparation

Active Ingredients

Only 1 Active Ingredient

Multiple Active Ingredients

Devices

Included

Without Device

Priorities

"Bread and Butter"

"Potential Blockbuster"

"Old/ New Products"

Products from Portfolio

30

Pros and Cons of using xml as the format

for the Data Acquisition

xml schema for IDMP had to be created that represents the IDMP data model

Example xml files can be created from the schema and taylored to match the customer‘s

products profile

Data groups (e.g. another CMO for a given product) can be added easily, copy and paste is

much easier in general

Data grouping is according to the IDMP data model (e.g. „Medicinal Product“)

Before a product xml file is stored, it can be validated against the IDMP data model

Graphical and text-based editing support

„Intelligent“ comparisons of xml files of different products

By copying xml files and modifying e.g. the medicinal product name registration data

multiple registrations can be handled easily


Why xml is also a useful basis for the further

implementation work

As long as there is no dictionary database used for the vocabularies, CV data needs to be

entered again and again

but:

Based on the xml schema, a database can be created that holds the data being created as

well as the dictionaries („Identity constraints“, resp. „key/ keyref“ attributes to be added to

xml structure)

Data that was captured in xml can be uploaded to the database and the database can be

used to acquire the IDMP data

Test data for the pilot can be collected

Substance data downloaded from GInAS can be mapped to the IDMP data model

Valuable material and data for the Requirements and Implementation Phase


The XML Schema used for the Analysis


The

Data

Collection

Process (1)

34

The Data

Collection

Process (2)

35

The Data Collection Process(3)


From Example: The Data Collection Process

Reevaluation of CTQs

37

Towards IDMP Implementation

Defining the Future Processes

Defining a High-Level Solution Architecture

Collecting User Requirements and RFP

Agenda


Future Process Design

• Based on Use Cases (see below)

• For each Use Case, the following description is provided:

- Goal of UC

- Scope

- Pre- and post conditions

- Process flowchart

- Actors and their interests

- Open issues

- Numbered, tabulated Requirements relating to the UC (with priorities and

CTQ references)

• Other requirements (Data, Organization etc.)39D.Schlaps; From IDMP Readyness Assessment...

High-Level Solution Architecture

Identification of Use Case Document

&

Structured

Content-

Manage-

mentSubstance

Data Base

(e.g.

GInAS)

ERP

Plat-

form(s) to

exchange

data with

Ext. P.

Drug

Safety

SystemMaster

Data

Manage-

ment

IDMP/ RIMS

Solution

EMA/ FDA

Substance

Databases

CROs,

CMOs

Public

Dictionaries

Health Autho-

rities

UC3

UC2UC4

UC1

UC1:

Create, update, review

and approve IDMP

data

UC2:

Submit IDMP data

UC3:

Maintain Controlled

Vocabularies

UC4:

Collect IDMP data from

other systems


Characteristics of New Process

• To be triggered by Product Submission process

• Departments are responsible for the provision for their parts of

the IDMP data

• Solutions will be provided to support the process of data

collection

• External manufacturers and affiliates need to be involved, too

• Master data/ Dictionary management needs to be implemented

• Product Responsible carries over-all responsibility


Questions?


IT Consulting Life ScienceHaider Straße 3082405 WessobrunnGermany

email: [email protected]: +49 (0) 160 96067530fax: +49 (0) 8809 163091

Your Contact

Dr. Dieter Schlaps

Thank you very much for your Attention!

D.Schlaps; From IDMP Readyness Assessment... 43

mailto:[email protected]

Schlaps_Final

Documents

Transcript of Schlaps_Final