Organisation Management Services (OMS) operating model

Transcription

1 3 July 2017 EMA/459105/2016 version 3 Information Management Division Organisation Management Services (OMS) operating model Table of contents 1. Executive summary OMS operating model Registration of Organisation data in the OMS system or requesting an update Key features and benefits of the OMS operating model OMS dictionary Key features of the OMS dictionary Expansion of the OMS dictionary Implementation of the phase I operating model Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 1. Executive summary This document is intended to provide both guidance and information for stakeholders who are supporting the implementation of SPOR and for all stakeholders who will be using SPOR data management services. The use of Organisation master data that is centrally managed can increase interoperability between systems and improve efficiency in managing regulatory data. Currently, the submission of Organisation data is based on free text manual entries. The benefits of introducing Organisation master data are that it is structured, standardised, validated and available for re-use. Its value increases the more it is re-used. Organisation Management Services (OMS) is one of the first projects to be delivered as part of the phased implementation of SPOR data management services and a key enabler for the implementation of ISO IDMP in the EU. The OMS solution will provide a consolidated source (also referred to as a single source) of Organisation data to be used across the EU Regulatory Network that can support regulatory activities across the Human and Veterinary domains. The solution comprises the technical component with the relevant features and data stewardship to manage and oversee the data. The core of the OMS solution will be a centralised process for registration of Organisation data also referred to as the OMS operating model. Organisation data management services will be made available through a web user interface and an Application Programming Interface (API). The implementation of structured Organisation data with unique IDs will support the implementation of ISO IDMP standards (ISO for unique identification and exchange of regulated medicinal product information and ISO for unique identification and exchange of regulated information on substances). 2. OMS operating model The OMS operating model establishes a common process, which will enable a more efficient and consistent way of managing Organisation data across the EU network. The process relies on industry and other parties alike, pre-registering Organisation data (or requesting updates) in the OMS dictionary before any regulatory submission takes place. A National Competent Authority (NCA) may request registration or an update of Organisation data in OMS (i.e. for manufacturers in order to prepare for an inspection). Stakeholders can use the OMS dictionary (list of organisations with associated physical locations) as the core data that is essential for specific business processes. For example, NCAs can reference the OMS data for validation of their own Organisation data in support of their regulatory procedures. The process is supported by the work of EMA data stewards who will manage the data. The overall objective of data stewards will be to apply consistent data quality rules and standards. Data stewards will also be responsible to validate change requests to update the OMS dictionary. EMA/459105/2016 Page 2/6

3 2.1. Registration of Organisation data in the OMS system or requesting an update The diagram below summarises the activities undertaken by industry, NCAs and EMA, specifically focusing on the registration of organisations in the OMS system and the submission of regulatory applications. when there is a need to update data in OMS, industry will pre-register a new organisation or request an update to existing organisation data in the OMS system before submitting a regulatory application to NCAs, by submitting a change request. Change requests can be submitted manually or programmatically; EMA data stewards will validate and process the change request; a notification will be provided to confirm the receipt of a change request; once the request is processed the outcome will be notified to the requestor and, if registration is accepted, relevant organisation IDs will be provided; following the validation and processing of a change request the relevant data will be automatically published in the OMS dictionary; once the Organisation data is available in the OMS dictionary, industry can then continue to submit an application as part of regulatory activities; Change requests will be validated in compliance with agreed Service Level Agreements (SLAs). Information relating to SLAs will be shared separately. The OMS operating model also allows for an NCA to pre-register an organisation in the OMS system or to request an update to an existing organisation. For example, an NCA might need to register an organisation in OMS in the context of an inspection activity. In such cases, the same steps as described above will apply. EMA/459105/2016 Page 3/6

4 Figure 1. Phase I Organisations operating model 3. Key features and benefits of the OMS operating model The OMS operating model comprises a number of key features, agreed with all stakeholders, which include: common process which requires industry and other parties alike to request registration of Organisation data before regulatory submission; OMS data hosted by EMA, accessible to and used throughout EMA, across the EU Regulatory Network and by other external stakeholders; OMS data is a single and trusted source of data; OMS data validated by the EMA data stewards and available in a structured format; establishment of a centralised dictionary of organisations to be used as a reference and in support of EU regulatory activities; Applications Programming Interface for exchange of Organisation data. 4. OMS dictionary OMS dictionary is a list of organisations with associated physical locations. EMA/459105/2016 Page 4/6

5 4.1. Key features of the OMS dictionary The content of the OMS dictionary will derive from EudraGMDP, xevmpd Art.57 and three other EMA corporate systems. In the future, new sources may be identified and Organisation data included in the OMS dictionary. Organisation data will be loaded to the OMS system following an extraction, transformation and load (ETL) process. A set of business rules have been defined to cleanse, standardise and consolidate this data before it is published in the OMS dictionary. This publication process will happen incrementally. The IDs stored in the source systems will also be loaded to OMS and thus mapped as a cross reference ID against each organisation/location record mastered in the OMS. In the OMS system there will be no differentiation between an organisation created in the context of a human medicinal product versus a veterinary medicinal product. The Organisation master data does not define which role(s) the organisation performs since this depends on the context in which the data will be used e.g. an organisation can act as an MAH in the context of one medicinal product but as a manufacturer for another medicinal product or as a Sponsor for different medicinal products. OMS plans to support hierarchical organisation relationship management through a future project Expansion of the OMS dictionary 1 The initial content of the dictionary at go-live included Regulatory Authorities/National Competent Authorities (NCAs). Data content will then be incrementally expanded as part of maintenance work and the following data sets will be included: Data set 1: Marketing Authorisation Holders (MAHs): Human (H) + Veterinary (V) Centrally Authorised Products (CAPs) and Human (H) Nationally Authorised Products (NAPs); Marketing Authorisation Applicants (MAAs): (H+V) CAPs; Maximum Residue Limit (MRL) applicants (Veterinary). Data set 2: Sponsors (H) CAPs and NAPs. Data set 3: Manufacturers (H+V) CAPs. Data set 4: Manufacturers (H+V) NAPs. EMA will communicate in advance to stakeholders about the timing of the release of new Organisation data in the dictionary and specify when industry can start submitting change requests for the Organisation data that has been added. Additional Organisation data will be published in the future and the prioritisation of its inclusion in the dictionary will be defined at a later stage: Veterinary MAHs for NAPs; 1 Section 4.2 was updated to reflected current OMS data release plan EMA/459105/2016 Page 5/6

6 Contract Research Organisations (CROs); Clinical trials sites; Academia; Hospitals; Wholesale distributers; MAA/MAH and manufacturers in the context of herbal and homeopathic medicinal products or compassionate use medicinal products; QPPV (Qualified Person for Pharmacovigilance). 5. Implementation of the phase I operating model EMA will deliver SPOR data services through the phased implementation of SPOR. SPOR will be the home of an EU-wide source of validated data that can be re-used by EMA, NCAs and industry in support of regulatory activities (e.g. Pharmacovigilance, marketing applications or clinical trials) across the product lifecycle, for products that are regulated in the EU. SPOR services will be enforced when they become mandatory in given regulatory business process, for example industry submission of products to support Pharmacovigilance activities (human), industry submission of applications (human and veterinary). The enforcement may vary between Human and Veterinary stakeholders according to the implementation timescales and integration with other solutions. In the context of the OMS operating model enforcement entails the pre-registration of organisation data in OMS and will become mandatory use in relevant business processes. At OMS go-live, submission processes will continue as before and there will be no immediate process changes for stakeholders. Some changes in the current submission processes are being explored and consultation is taking place with stakeholders on these. More information will be provided in due course to explain any applicable process changes and timings. EMA/459105/2016 Page 6/6