cunesoft webinar slides: iso idmp via regulatory master data management

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© 2015 Cuneso- GmbH

IDMP – Iden8fica8on of Medicinal Products A master data driven approach and it‘s benefits

Rainer Schwarz Daniel Koppers

May 7th, 2015

© 2015 Cuneso- GmbH 2

Increased Data Scope

xEVMPD -‐ 30 -‐

IDMP -‐ 250 to 500 -‐

July 2012 July 2016 Due Date

Structured Informa<on items/product

100

200

300

400

500

16x more data


IDMP – A master data driven approach and it‘s benefits

§  Introduc8ons §  IDMP Summary & Status §  Regulatory Master Data Concept §  Case Study: So-ware based IDMP §  Cuneso- IDMP Ramp Up Program §  Q&A


Company Overview

Venture Partners:

Rainer Schwarz

CEO

§ More than 14 years experience with compliant so-ware solu8ons for regulated processes

§  Senior management posi8ons at CDC Solu8ons, Liquent and NextDocs

§ Business experience in Europe, USA and Asia

§ Master of Social Sciences of the University of Innsbruck and Hong Kong University

!

Daniel Koppers

CTO

§ More than 7 years experience with so-ware development and project management

§ Deep knowledge of life sciences and regulated industries. Regula8ons know-‐how such as CFR 21 Part 11 and GxP valida8on

§ Expert in Microso- technologies

§ Degree in Business Informa8cs

!

Recogni<on and Cer<ficates:

ISO 27001/27002

„Regulatory processes

done right“

Headquarters: Munich, Germany

Regional Office: Paris, France

Established: 2013

Team Size: 15

Business: Provides pioneering regulatory so-ware

Technology Partner: Microso-

Website: www.cuneso-.com


Integrated Regulatory SoXware

cune-‐RDMS

cune-‐Portal

cune-‐ IDMP

cune-‐Track

cune-‐eCTD

Ø  cune-‐RDMS Create, review, approve and sign submission related documents according to FDA 21CFR part 11 requirements.

Ø  cune-‐eCTD Create new or import exis8ng electronic submissions and compile all types of eCTD s ubm i s s i on s i n c l ud i n g eCTD l i f e c y c l e management.

Ø  cune-‐Track Create a submission data base, track all regulatory events and include authority correspondence in one comfortable system.

Ø  cune-‐SOP Manage Standard Opera8ng Procedures (SOP’s) from beginning to end. Distribute to employees and automa8cally track training records.

Ø  cune-‐IDMP -‐ new Holis8c Regulatory Master Data Management to manage pharmacovigilance related submissions such as xEVMPD, IDMP based on HL7 output standards.

Integrated Regulatory SoXware -‐ What we do

cune-‐ SOP


Introduc<ons IDMP – Iden8fica8on of Medicinal Products

ISO 11615

ISO 11616

ISO 11238

ISO 11239

ISO 11240

Medicinal product informa<on

Pharmaceu<cal product informa<on

Pharmaceu<cal dose forms, units of

presenta<on, routes of administra<on and

packaging

Substances

Units of measurement

Five ISO standards define the framework (approved in 2012)


Dossier

Manufacturing

Pharmaceu8cal Product

Packaged Product

Medicinal Product

MPID (S)SID PhPID PCID

IDMP codes

IDMP Gateway

Mandatory (July 2016 for EU)


MPID – Medicinal Product ID (S)SID – Substance ID PhPID – Pharmaceu8cal Product ID PCID – Packaged ID



Some helpful known facts:

1.  Legisla8ve requirement for all European MAH from July 1st of 2016

2.  ISO IDMP guidelines provide a complete data model framework

3.  Implementa8on guides (IG) have not been defined as of today

4.  IG‘s will provide instruc8ons mandatory/op8onal fields/ business rules/ data types

5.  ISO 11238 -‐ Global Ingredient Archival System (GInAS) will be used

6.  ISO 11239 -‐ Pharmaceu8cal dose forms / units of presenta8on / routes of administr. (EDQM) will be used

7.  ISO 11240 -‐ Unified Code for Units of Measure (UCUM) will be used

8.  Submission format will be based on the norma8ve messaging standards i.e. HL 7 standard


IDMP – Substance Data Model – Part I

* Source: ISO 11616 -‐ PhPID model: GLUBRAVA® (pioglitazone and memormin)

Sources

GInAS

EDQM

UCUM

Manual Defini8on


IDMP – Substance Data Model – Part II

* Source: ISO 11616 -‐ PhPID model: GLUBRAVA® (pioglitazone and memormin)

Sources

GInAS

EDQM

UCUM

Manual Defini8on


IDMP – Challenges resul<ng from the data model

1. Complex data model •  IDMP is much more than just an extension to xEVMPD •  It is a detailed descrip8on of

o  Substances o  Produc8on procedures o  Other ingedrients o  Packaging

2. Distributed sources of informa<on •  ERP System(s) •  Regulatory Opera8ons System (Submissions, RIM etc.) •  Proprietary legacy data such as Excel •  External partners (CMO, CRO etc.) •  External data repositories (such as EVWeb) •  Paper documenta8on

3. Required ini<al change management •  Consolida8ng data sources •  Cleaning data •  Centralizing data into one summary IDMP repository

4. Required on-‐going data accuracy •  Con8nuous data updates •  Tracking of data changes •  Upda8ng exis8ng submissions


Alterna<ves on how to approach IDMP challenges

1.  Manual data collec8on and data entry into EVWEB 2.  Outsource to a service provider 3.  Tac8cal use of a (simple) so-ware tool 4.  Strategic approach via seeing it as a chance for change 5.  Use a combina8on of the above

§  Does manual data management scale for more than one product ? §  Since IDMP is not just an extension to xEVMPD, is there a tac8cal way at all ? §  How effec8ve can outsourcing be, to gather complex internal data ? §  If a „simple“ so-ware tool is being used, how much manual work remains ? §  What would be the benefits, if IDMP is seen as chance for change ? §  Since the data requirements are complex, what else besides the IDMP

submission can be done with all the data ? §  What would be the detailed solu8on, if IDMP is approached strategically

Possible solu<ons alterna<ves:

Ques<on that might help to decide:


Strategic Approach -‐ Regulatory Master Data Management (R-‐MDM)

Requirements for an IDMP compliant R-‐MDM

Regulatory single source of truth •  Centralized database containing latest informa8on •  Synchronized automa8cally •  Federated into one well defined data core – automa8cally

Include external systems •  Connect external systems and reuse exis8ng data •  Well defined concise API‘s supported by most modern systems •  Direct database connec8ons into clear database schemas

Reports and Sta<s<cs •  Limit unnecessary data redundancies •  Standard reports for daily, weekly, monthly regulatory repor8ng •  Re-‐use exis8ng repor8ng systems to capitalize on data mining

"With the increasing focus on digitaliza8on of enterprises, management of their key master data is also becoming more important. The ability to achieve and maintain a single, seman8cally consistent version of product master data is crucial for customer-‐centric organiza8ons." Source: The Gartner Group

IDMP submission crea<on and maintenance •  Produce compliant IDMP data output •  Reduce manual work via gateway connec8ons •  Business rules func8ons for automa8c data updates

Federated

Share

Synchronise

Core


IDMP – Data Ecosystem

Regulatory Master Data „Single Source of Truth“

UCUM

EDQM

GInAS

Contract Manufacturers

CRO‘s API Supplier

Data Input Processing Data Output Submissions Ø  IDMP Ø  Other HL7 Output Ø  eCTD Ø  eCTD 4.0 Ø  Adverse Events Ø  ICSR

Regulatory Infoma<on Ø  Submission Planning Ø  Renewal No8fica8ons Ø  Early Warning Ø  Overdue No8fica8ons

Task Management Ø  Task Distribu8on Ø  Resource Manageement Ø  Affiliates Management

Regulatory Reports Ø  Repor8ng Ø  Regulatory KPI Tracking

eCTD

Excel

xEVMPD

ERP

Regulatory Archive Ø  Submissions Archive Ø  Documents Archive

CTMS


IDMP – Data Ecosystem

Regulatory Master Data Manager

Data Input Processing Data Output

cune-‐RDMS

cune-‐Portal

cune-‐ IDMP

cune-‐Track

cune-‐eCTD

cune-‐ SOP

Submissions Ø  IDMP Ø  Other HL7 Output Ø  eCTD Ø  eCTD 4.0 Ø  Adverse Events Ø  ICSR

Regulatory Infoma<on Ø  Submission Planning Ø  Renewal No8fica8ons Ø  Early Warning Ø  Overdue No8fica8ons

Task Management Ø  Task Distribu8on Ø  Resource Manageement Ø  Affiliates Management

Regulatory Reports Ø  Repor8ng Ø  Regulatory KPI Tracking

Regulatory Archive Ø  Submissions Archive Ø  Documents Archive


cune-‐RDMS

Import Documents Regulatory Templates Review and Approve Electronic Signature

cune-‐eCTD

Import or New eCTD’s Auto Compile Check Compliance Submit to Gateway

cune-‐Track

Track registra8on tasks Assign regulatory tasks Monitor via workflows Automa8c no8fica8on

cune-‐SOP

SOP Management Training Records FORMS Management Change Control

Regulatory Master Data Management External Data Import

Repor<ng Submission Prepara<on

•  User friendly regulatory •  Based on xEVMPD and ISO IDMP models •  Includes smart access to external databases •  Integrated with GInAS •  Integrates with UCUM •  Integrates with EDQM

cune-‐IDMP

cune-‐IDMP

Master Data xEVMPD Submissions IDMP Submissions HL7 Support

•  Imports historical EVMPD’s and xEVMPD’s •  Connects your external business partners (i.e.

CRO’s, CMO’s etc.) via a secure data management portal to have them share their IDMP relevant data

•  Gains you unprecedented regulatory data insight via dynamic reports and by u8lizing rich filtering capabili8es.

•  Shapes regulatory data based on needs by applying sor8ng, filtering, grouping and adding addi8onal meta data fields.

•  Facilitates automated business rules based on a variety of triggers such as external or internal data changes, regula8on changes or other external factors.

•  Publishes xEVMPD, IDMP HL7 compliant submissions and other (future) submission formats.


IDMP – CunesoX Ramp Up Program – email: [email protected]

Step 1

Data Analysis

1. IDMP Test System Access

2. Delta Data Workshop (xEVMPD versus IDMP)

3. Analyse Data Sources §  xEVMPD §  Pharmaceu8cal Product §  Manufacturing §  Packaged Product

Result: Data Analysis Summary

Free – Register Now

Step 2

Data Collec<on & Entry

1. IDMP Test System Access

2. Data Assembly §  GiNAS, UCUM, EDQM §  External: CMO, CRO, API etc. §  Internal Submission Import §  Internal Legacy Import (Excel) §  Internal Paper Based Data §  Internal Manual Data Entry

Result: IDMP Data Report

Services Fees

Step 3

IDMP Submission Prepara<on

1. IDMP System Rollout §  Configura8on §  API connec8ons §  Valida8on §  User Training

2. Cc‘d Data Collec8on & Entry

3. Regulatory Repor8ng

Result: IDMP Submission

So-ware License & Services Fees

May-‐June Jul-‐Sep From Oct


Become a happy customer ! Rainer Schwarz Email: [email protected] Tel: +49 (0)89 235 14 741

cunesoft webinar slides: iso idmp via regulatory master data management

Business

types of ectd submissions

idmp 250to500

ectd lifecycle management

exis8ng electronic submissions

submission data base

regulatory events

increaseddatascope xevmpd

danielkoppers cto