Data Management

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ISO IDMP | Data Governance Services & RIMs Implementation | xEVMPD

Data Management

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the unique Identification of Medicinal Products, thus called “ISO IDMP”.

The main purpose of ISO IDMP is to allow the standardization of data both for authorised and investigational medicinal products for human use and veterinary products.

The five ISO IDMP standards establish the definitions and concepts that describe the data elements and their structural relationships. This enables the unique identification of:

  • Medicinal product information (MPID/PCID) – ISO 11615
  • Pharmaceutical product information (PhPID) – ISO 11616
  • Substances (Substance ID/Specified Substance ID) – ISO 11238
  • Pharmaceutical dose forms, units of presentation, routes of administration and packaging – ISO 11239
  • Units of measurement (UCUM) – ISO 11240

 


 

EMA is implementing ISO IDMP trough a phased programme called SPOR that is based on these 5 ISO standards.

SPOR comes from:

  • Substance: Harmonised data and definitions to uniquely identify the ingredients and materials that constitute a medicinal product.
  • Product: Harmonised data and definitions to uniquely identify medicinal product based on regulated information (e.g., marketing authorisation, packaging and medicinal information).
  • Organizations: Data that comprises organisation name and location, address data for organisations, such as MAH, sponsors, regulatory authority, manufacturers.
  • Referentials: Lists of terms (controlled vocabularies) used to describe attributes of products, e.g., lists of dosage forms, units of measurement and routes of administration.

There is a legal obligation for the industry to make use of the terminologies defined in ISO IDMP standards, as stated in Regulation (EU) No 520/12012 (art. 25 & 26).

SPOR is an ISO IDMP compliant business service that allows the central management of data based on four main services: SMS-Substance Management Service, PMS-Product Management Service, OMS- Organizations Management Service and RMS- Referentials Management Service. SPOR applies to both areas, human and veterinary.

Its purpose is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.

 


 

The introduction and progressive implementation of new IDMP standards means that organizations will need to capture and manage significantly more regulatory data than ever before, which represents a significant challenge to the industry as a whole.

Effective data management involves significant effort, is time-consuming and costly.

Every stakeholder in the pharmaceutical sector is creating and manipulating data: Industry, Agencies, MAHs and other Organizations. Data is an asset, unless is not organized, understandable and accessible. Inconsistent, disorganized and non-accessible data only causes delays, increased costs and process difficulties, among others.

SPOR is expected to improve not only how data is created, manipulated and maintained but, ultimately, how other stakeholders can use it for the improvement of regulatory activities, pharmacovigilance, inspections and other, such as shortages, falsified medicines directive, prescription, etc.

Organizations need to capture and manage significantly more data than ever before, which represents a significant challenge to the industry as a whole. Furthermore, they need to adjust their data governance processes, which involves significant effort, is costly and time-consuming.

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the unique Identification of Medicinal Products, thus called “ISO IDMP”.

The main purpose of ISO IDMP is to allow the standardization of data both for authorised and investigational medicinal products for human use and veterinary products.

The five ISO IDMP standards establish the definitions and concepts that describe the data elements and their structural relationships. This enables the unique identification of:

  • Medicinal product information (MPID/PCID) – ISO 11615
  • Pharmaceutical product information (PhPID) – ISO 11616
  • Substances (Substance ID/Specified Substance ID) – ISO 11238
  • Pharmaceutical dose forms, units of presentation, routes of administration and packaging – ISO 11239
  • Units of measurement (UCUM) – ISO 11240

 


 

EMA is implementing ISO IDMP trough a phased programme called SPOR that is based on these 5 ISO standards.

SPOR comes from:

  • Substance: Harmonised data and definitions to uniquely identify the ingredients and materials that constitute a medicinal product.
  • Product: Harmonised data and definitions to uniquely identify medicinal product based on regulated information (e.g., marketing authorisation, packaging and medicinal information).
  • Organizations: Data that comprises organisation name and location, address data for organisations, such as MAH, sponsors, regulatory authority, manufacturers.
  • Referentials: Lists of terms (controlled vocabularies) used to describe attributes of products, e.g., lists of dosage forms, units of measurement and routes of administration.

There is a legal obligation for the industry to make use of the terminologies defined in ISO IDMP standards, as stated in Regulation (EU) No 520/12012 (art. 25 & 26).

SPOR is an ISO IDMP compliant business service that allows the central management of data based on four main services: SMS-Substance Management Service, PMS-Product Management Service, OMS- Organizations Management Service and RMS- Referentials Management Service. SPOR applies to both areas, human and veterinary.

Its purpose is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.

 


 

The introduction and progressive implementation of new IDMP standards means that organizations will need to capture and manage significantly more regulatory data than ever before, which represents a significant challenge to the industry as a whole.

Effective data management involves significant effort, is time-consuming and costly.

Every stakeholder in the pharmaceutical sector is creating and manipulating data: Industry, Agencies, MAHs and other Organizations. Data is an asset, unless is not organized, understandable and accessible. Inconsistent, disorganized and non-accessible data only causes delays, increased costs and process difficulties, among others.

SPOR is expected to improve not only how data is created, manipulated and maintained but, ultimately, how other stakeholders can use it for the improvement of regulatory activities, pharmacovigilance, inspections and other, such as shortages, falsified medicines directive, prescription, etc.

Organizations need to capture and manage significantly more data than ever before, which represents a significant challenge to the industry as a whole. Furthermore, they need to adjust their data governance processes, which involves significant effort, is costly and time-consuming.

Our Solutions

At Asphalion we can give you support and help you navigate through the awareness process and work with you to be ISO IDMP compliant whether you have, need or can’t yet access a RIM system.

  • Consultancy about ISO-IDMP requirements
  • Trainings to support your ISO IDMP knowledge
  • Strategic input support to make you succeed in your project
  • Pharma data management: data collection and/or extraction, data verification, mapping and cleaning
  • Finding different solutions if a RIM system is not a possibility
  • Tool and process adaptation for ISO-IDMP compliance
  • Data mapping with SPOR master data
  • GAP analysis of IDMP readiness
  • ISO-IDMP enrichment

 

Given the before mentioned tasks that lie ahead for any pharmaceutical company, it is important to start with the regulatory strategy as soon as possible in order to get an estimation of the effort that will be necessary to be compliant.

Regulatory Information Management (RIM) system is a vital element of any regulatory strategy, since it allows processes and data governance optimization. RIMs are becoming even more essential with the upcoming ISO IDMP implementation, as it offers “directed” solutions to comply with the standards and regulations.

There is no RIM that fits all, but certainly a wide variety of solutions that can adjust to the needs of each company. Not a single pharma software company is the same, with regards to the number of Marketing Authorizations, type of products, region of activities, manufacturer of finished product and/or active substance, etc.​ Once you have taken a decision, Asphalion can give you support along the customization phase and help you make the most out of the solution of your choice. Furthermore, our experience allows us to continue supporting the implementation of the system along the way in the most efficient manner.

Selection of RIM:

  • Set-up of user requirements, functional specifications

 

Migration:

  • Consulting for business process translation into RIM
  • Migration plan
  • Data mapping (Data models, Data Export, Data mapping)
  • Gap analysis
  • Enrichment (Design and Execution)
  • Import tables creation
  • Data verification
  • Migration

 

Validation:

  • Design, review, consulting and execution in different phases

 

Active Regulatory Review

 

Project Management:

  • Defining project milestones and planning
  • Review and approval of deliverables
  • Project monitoring until Go-Live

 

Training and others:

  • User manual design
  • SOP and WI updates
  • Trainings and training materials related to the system

 

xEVMPD is the Extended Eudravigilance Medicinal Product Dictionary of the European Medicinal Agency (EMA), which defines controlled vocabulary to be used for the marketing authorisation of medicinal products.

The submission of data on medicines by marketing authorisation holders is a legal requirement from Article 57(2) of Regulation (EC) No. 726/2004, as amended by Regulation (EU) 1235/2010 and Regulation (EU) 1027/2012.

At Asphalion we have a dedicated team, fully trained and greatly experienced in supporting the activities related to xEVMPD. Proactively, we provide pre-filled templates that ease providing the required information for the creation and maintenance of data. We offer a quick and efficient solution that allows you to be compliant and on time.

We support the data entry and data maintenance following variations, renewals and other activities with close and clear communication. We can as well support you with quality checks to ensure correctness of data in order to be ISO IDMP ready.

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Why Asphalion?

As a partner, Asphalion is a valuable asset for a variety of projects within the Regulatory field, offering not only technical expertise but a vision and a mission that are aligned with the current and future clients’ needs.

 

Why choose Asphalion for RIMS Implementation?

As an essential partner for a successful and efficient RIMS implementation, Asphalion is committed to bringing its extensive regulatory affairs knowledge in the partnership, combined with a vast collaboration experience with key actors in the pharma sector.

Asphalion has effectively supported the implementation of RIM systems in over 10 companies with a different range of products and portfolios (7,000+ MA and 100,000+ documents), and with different systems of origin and destiny. Moreover, we offer a regulatory and operational vision on human medicinal products, animal health, innovative, OTC and generic products, as well as expertise both as users and implementation partners with several vendors.

 

Why choose Asphalion for ISO-IDMP Transition?

Keeping up with the current and constant changes within the sector, Asphalion has a dedicated team for ISO IDMP and data governance and is in direct contact with EMA, thus heavily involved in the review of the EU Implementation Guide. As a continuous support partner, Asphalion strives to offer different solutions for compliance that accommodate our clients’ needs (xEVMPD, SPOR, PMS, etc.).

At Asphalion we have successfully been driving the transition into ISO IDMP for our clients in a comprehensive manner in different phases: a) Initial Awareness by providing trainings on ISO IDMP, as well as specific data driven requirement trainings to comply with the Iteration 1 of the PMS implementation; b) Preparation phase, supporting and defining milestones and objectives to establish an efficient action plan; and c) Hands-on phase, driven by the full support on data mapping, quality and enrichment.

 

Why choose Asphalion for compliance with xEVMPD?

Asphalion has been providing xEVMPD submission services for ten years, more specifically since Art. 57 obligation came into force on July the 1st, 2012.

Annually, Asphalion manages an average of 3,500 petitions for over 31 Clients, among new MAs, updates, renewals, invalidations, suspensions and transfers. Additionally, we also perform massive updates (bulk updates) and product exports both in xml. and in excel formats, among other maintenance activities.

Beatriz Goñi - Asphalion
Beatriz Goñi, PhD
Regulatory Affairs Director
“As a partner, Asphalion is a valuable asset for a variety of projects within the Regulatory field, offering not only technical expertise but a vision and a mission that are aligned with the current and future clients’ needs”

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