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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