This IDMP Solutions Category classifies different IDMP Solution vendors and their IDMP Solution IT Systems.

IDMP Wiki

IDMP Cost for the Companies

IDMP Cost has been evaluated across 14 EFPIA member companies.

idmp cost

The data required for XEVMPD was predominantly already held by regulatory affairs, although for the majority of companies, some additional data had to be collected from within regulatory affairs. In addition, a typically limited amount of information came from pharmacovigilance and drug safety.

Collation and provision of IDMP data will have significant ramifications for industry but also potential opportunities for the ways companies manage and share data. Overall, IDMP is not data that sits solely in regulatory affairs, and significant parts of it are—or should be—corporate data. Essentially there is the potential that IDMP can drive or support master data management initiatives in industry as well as at the European Medicines Agency. The need to address provision of additional information can be a driver for rationalising the ways companies manage their own data whereby they establish a single authoritative source that is aligned with the ISO standards rather than create yet another instance of data that might have to be manipulated and then maintained independently.

Challenges for most companies in terms of data will be:

  • Locating an appropriate source of the relevant data
  • Ensuring that the data aligns with the granularity, vocabularies, and data types of IDMP
  • Establishing a mechanism to maintain the data
  • Ensuring consistency of the data to be submitted with that which may be identified during pharmacovigilance

The chart below illustrates that the combined actual cost of XEVMPD across 14 companies exceeded €28M; cost of the ISO IDMP switch is conservatively forecasted to exceed €38M across these same companies. Therefore, a sampling of 14 European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies indicates a combined expenditure of at least ~ €70M for implementing XEVMPD and IDMP.

wiki idmp cost efpia screenshot

The chart is drawn out of the Position Paper from the EFPIA:
“Principles for the Implementation of ISO IDMP Standards for EudraVigilance and Development of a Road Map – Final, 6th Oct. 2014”

IDMP Wiki

IDMP Gap Analysis

 IDMP Gap Analysis

It is important to create a common understanding for the project of an IDMP Gap Analysis across the company. So typically all departments should be involved.

IDMP Gap Analysis
How can an IDMP Gap Analysis help you make your data management a success?

IDMP defines a precise structur for medicinal products mapped with controlled vocabularies.

 

The steps for the IDMP Gap Analysis could be:

  1. Identify on a very high level the data sources and the owners that are candidates for extraction of idmp required data
  2. Define some test products which offers variations in product type, substances (mono, combi with different strength), in-licensed products etc., old new products, centralised, mutual recognition procedure, decentralised procedure, and national procedure to be encoded and structured in IDMP. It is also advisable to use some local language SPCs for national products as they will have to be aligned with the IDMP data.
  3. Extract the required data manually out of the identified sources (step 1) and check if all needed information is available. Classify the quality of the extracted data in effort categories such as:
    a. single source which can be mapped to IDMP
    b. single source which requires significant effort to format data for mapping to IDMP
    c. available in multiple systems requiring harmonisation, or with poor data quality
    d. unstructured Data (Documentation)
    e. location not found; substantial manual effort to retrieve information
  4. Define (based on the outcome of step 3) your user requirements and potential high-level solution architecture. This can vary from an inhouse solution up to a wide range of solution scenarios with or without an integrated Master Data Management system
  5. The final step is the Request For Proposal (RFP) and the vendor selection and implementation

Five EFPIA member companies published their results in their IDMP Gap Analysis (as of 20.6.2015).

Overview of Industry Effort Calculation
wiki gap analysis efpia effort calculation
Effort Calculations Averaged per Field
IDMP Wiki

IDMP Solutions and IDMP Vendors Overview

IDMP Solutions

This IDMP Solutions Wiki  is a place to find IDMP collaborations, IDMP solutions, and news about IDMP vendors´systems.

IDMP Solutions and IDMP Vendors

This Wiki gives you an overview of the different IDMP IT solutions offered at this time. The content is based on information published by the different vendors. Please feel free to comment or to give us more insight in your cooperate solutions or experiences you made in your IDMP projects.

Webtool
IDMP Webtools
Vendor(s)System NameDescriptionIDMP1 Interface
EMAIDMP WebtoolIDMP data will have to be typed in manually (comparable to EMA´s EVWEB tool).No
IDMP1 GmbHIDMP Term BrowserThis term browser lists terms consistent with the ISO 11239, ISO 11240, ISO 11615 standard.Yes
IDMP1 GmbHIDMP Drug DictionaryThis drug dictionary lists international medicinal products consistent with the ISO 11616 standard.No
IDMP1 GmbHIDMP Word LookupThis IDMP MS Word Plugin secures better IDMP conform standard terms in MS Word documents.Yes
RIM incl. IDMP
RIM System including IDMP Solution (integration)
Vendor(s)System NameDescriptionIDMP1 Interface
CSC Regulatory TrackerCSC’s Regulatory Tracker helps track and manage your life sciences products throughout the global registration and regulatory process. No
InfotehnaRIMExpertRIMExpert™ is a regulatory information management tool that can answer all questions relevant to Regulatory Affairs, and present this information in dashboards, tables or in exportable dynamic reports.No
LorenzDrugTrackA versatile, low-footprint multi-user system to manage all your regulatory activities, including the EVMPD requirements. It will also support the ISO IDMP format when it comes into force.No
SamarindRMS RIMSamarind RMS is a configurable off-the-shelf (COTS) database software solution for regulatory affairs (RA) and pharmacovigilance (PV) professionals. No
RIM Plus IDMP
RIM Plus IDMP Specific System
Vendor(s)System NameDescriptionIDMP1 Interface
ArisGlobalagIDMPagIDMP is a unique IDMP solution that can be easily used within the technical solution landscape of any pharmaceutical company to be compliant with IDMP.No
EXTEDO MPDmanagerMPDmanager is a data base system. It provides the functionality of a central product data repository and integrates with RIMS to provide a single source of truth for medicinal product data. No
Master Data Management for IDMP
Vendor(s)System NameDescriptionIDMP1 Interface
Informatica Master Data Management will help assembling IDMP data from the different sources. No IDMP reporting.No
SAPMaster Data Management will help assembling IDMP data from the different sources. No IDMP reporting.No
SASSAS provides the SAS® IDMP Data Hub based on extensive data management capabilities.No
OracleMaster Data Management will help assembling IDMP data from the different sources. No IDMP reporting.No
Mapping
IDMP Mapping Solutions
Vendor(s)System NameDescriptionIDMP1 Interface
IDMP1 GmbHIDMP Vocabulary ServerThe IDMP Vocabulary Server (API) shares IDMP terms between software applications.Yes
IDMP1 GmbHIDMP Text EncoderThe IDMP Text Encoder allows to structure and mapp textual data with the IDMP terms.Yes
All in One
IDMP Mapping Solutions
Vendor(s)System NameDescriptionIDMP1 Interface
Nanokinetik Ready! for IDMPREADY! for IDMP comprises of the following main elements:
  • An integration service, for data retrieval, validation, and standardization of product data from different data sources (Documentum, Oracle, SAP, Excel, custom)
  • A web application and product database to manage and clean-up product information
  • A gateway for exchanging messages with regulatory authorities
  • Automatic validation of data prior to submitting
  • Tracking and management of all sent and received messages
  • Interface to the IDMP1 Mapping Services

Yes
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IDMP Wiki

MDM

Master Data Management (MDM) is critical for IDMP compliance

In matching IDMP´s required data with customer´s data there will be several systems identified which hold IDMP relevant data.

In case of Marketing Authorisation Holders (MAHs) this will be Regulatory Information Systems (RIMs) which must be focused on. The RIM will be source for most of regulatory input, partly for substances, marketing and a small part of the packaging data. But more details may be needed from other systems.

Master Data Management will help assembling these data from the different sources, augmenting them by further data, preparing them for submission and matching the internaly used vocabularies against IDMP´s controlled dictionaries.

What impact will IDMP have on Providers of Structured Drug Information Systems?

IDMP will not only become standard for regulatory purposes. Furthermore it will also become the standard model used for systems in Pharmaceutical Information Systems, Drug Dictionaries, Clinical Decision Support, Hospital Information and Patient Information. So the impact of IDMP on providers of such systems is significant!

What are the key steps of a gap analysis and which next steps should be done?

It is important to create a common understanding for the project across the company. So typically all departments should be involved. The steps could be:

  1. Identify on a very high level the data sources and the owners that are candidates for extraction of idmp required data
  2. Define some test products which offers variations in product type, substances (mono, combi with different strength), in-licensed products etc., to be encoded and structured in IDMP
  3. Extract the required data manually out of the identified sources (step 1) and check if all needed information is available. Classify the quality of the extracted data in effort categories such as:
    a. single source which can be mapped to IDMP
    b. single source which requires significant effort to format data for mapping to IDMP
    c. available in multiple systems requiring harmonisation, or with poor data quality
    d. unstructured Data (Documentation)
    e. location not found; substantial manual effort to retrieve information
  4. Define (based on the outcome of step 3) your user requirements and potential high-level solution architecture. This can vary from an inhouse solution up to a wide range of solution scenarios with or without an integrated Master Data Management system
  5. The final step is the Request For Proposal (RFP) and the vendor selection and implementation

How can IDMP1 help you make your IDMP project a success?

The ISO IDMP standard will not only be the standard for regulatory affairs, but it will also become the standard model for pharmaceutical information systems used in in public information systems for patients, in clinical decision support in hospitals and in e-health.

IDMP1 offers structured data for medicinal products mapped against the IDMP´s required structure and controlled vocabularies. Its IDMP Drug Dictionary is an excellent starting point to define the structured representation of S(m)PC documents´content (e.g. for clinical particulars).

IDMP Wiki

SPOR

SPOR

(as of 17.2.2017, Ursula Tschorn, IDMP SPOR Industry Change Liaison)

SPOR is short for Substances Products Organisations and Referentials in the IDMP projects of the EMA. SPOR data services will act as the vehicle for implementation of ISO IDMP standards in the regulatory and the e-health world.

SPOR data services

SPOR is aimed at delivering quality data services on Substances, Products, Organisations and Referentials to power EU regulatory activities.

Four projects have been established

Four projects have been established at the EMA to implement services that centralise management of each of the domains of master data. The four projects are collectively known as SPOR data services and the single once are abbreviated with SMS, PMS, OMS and RMS.

SPOR Data Services

SPOR Data Services

Implementation of the four projects

The implementation of the four projects will be phased.

  • All proposals relating to implementation of the projects on Substances, Products, Organisation and Referentials have been and will continue to be consulted on widely with regulators and industry representatives.
  • IDMP with its referentials applies to both domains, Human and Veterinary
  • In parallel, EMA is implementing the messaging standards developed by Health Level Seven (HL7), which define a format for the electronic exchange of data that is compliant with the ISO IDMP technical specifications.

Use of SPOR in regulatory activities

Adoption of IDMP operating models will facilitate the implementation of consistent, centrally-maintained, ISO IDMP-compliant data, which will feed regulatory activity across the product lifecycle.

Benefits

Standardised data alone is not sufficient to achieve benefits. The benefits will be realised incrementally:

  • As all phases of SPOR are completed; and
  • Provided other opportunities for integration are implemented via EU Telematics Programmes such as CESSP, Clinical Trials EU Portal

New ways of accessing SPOR data

There are 4 ways of accessing the SPOR data:

  • web interface
  • APIs* (Application Programming Interface)
  • Draft API specifications have been shared with SPOR Task Force; final API specifications are expected to be published in August
  • For RMS, backward compatibility will be maintained with EUTCT for NCAs who use EUTCT
*An API is a mechanism to allow your IT systems to exchange information automatically with RMS and OMS

Download SPOR API Documentation

A new edition (version 1.7 published 9.2.2017) of the SPOR API documentation (API schemas, OMS & RMS message formats and HL7) is accessible for interested parties for a free download in this website:

SPOR-API-Specification-1.7.ZIP published 09 Feb 2017 (85 downloads)

The latest version of the API specification incorporates the following additional information:

  • A description of how an implementing system must retain rowid elements in the creation, and later management, of change requests in RMS.
  • A description on the fields that have to be conditionally provided when dealing with both OMS and RMS change requests depending on the status and the data of such requests.
  • An explanation on how OMS retains compatibility for searching elements based on identifiers, even after they have been merged, and how the current identifier, of an element, is highlighted in the response data.
  • A description on what kind of change requests can be filed in OMS depending on the status of the referred organisation and/or location.
The API specification covers both RMS and OMS. This has been taken through consultation during April to July 2016 and the feedback has been incorporated in the specification (consultation is now closed).
wiki spor documentation

Please note that in the SPOR API specification, the services are set out in Section 6 and those that are OMS-specific are marked “O”, RMS-specific are marked “R”, and services shared by both RMS and OMS are marked as  “RO”.

The documents have been shared with the SPOR Task Force and UAT testers.

EMA Data Stewards

EMA will take over the function of a data steward to maintain and coordinate the SPOR data.

  • A specialised team of EMA staff that will manage data on behalf of stakeholders and provide user support
  • Validate access requests to SPOR services
  • Directly involved in maintaining the quality of the data:
    Profiling the data (assessing quality of data)
    Various data anomalies (different formats of the data e.g. telephone number) can be identified / monitored and data correction can be initiated
    Reports generated using this cleansed data will be more reliable
  • Take action on change requests for new/amended Referential Lists/Terms and Organisation data

Data content

RMS lists at go-live:

  • Lists from EUTCT (apart from Substance list)
  • Lists to support OMS
  • Lists for ISO 11239 (Pharmaceutical dose forms, units of presentation, routes of administration and packaging) and ISO 11240 (Units of measurement)
  • Some lists to support  PMS project (e.g. Material)

Content of the OMS dictionary at go live:

  • MAHs: (H+V) CAPs & (H) NAPs
  • MAAs: (H+V) CAPs
  • MRL applicants (Vet)
  • MA & MRL contacts: (H+V) CAPs

 

Referentials Management Services RMS Operating Model

wiki spor rms process in regulatory context

 

 

Organisations Management Services OMS Operating Model

SPOR Organisation Operating Model

 

Key Industry engagement activities

  • Industry is now asked to start with mapping activities from their local data to IDMP SPOR referentials
  • Industry Change Liaisons will provide a continuous channel for information and training throughout the year
  • In addition, a number of specific events are planned that will be open to all Industry stakeholders

In summary

  • SPOR data services will act as the vehicle for implementation of ISO IDMP standards
  • SPOR data services will enable the realisation of benefits at all stages of the product lifecycle due to future integration of regulatory processes with SPOR’s standardised data and central data management services
  • Implementation of RMS and OMS is the first step in a phased approach to roll-out of SPOR and of other Programmes dependent on SPOR data
  • In order to be ready for the future changes brought about by IDMP and by integration with other Programmes, Industry should prepare now to ensure they have the foundations in place through alignment with RMS and OMS

Webinar Implementing ISO IDMP: introduction to SPOR data services

Link to EMA´s Information on Substances, Products, Organisations and Referentials