Update on ISO IDMP and SPOR projects

Transcription

1 Update on ISO IDMP and SPOR projects TOPRA Veterinary Medicines Symposium 2017 Presented by Isabel Chicharo - Deputy SPOR Programme Manager, Business Data & Analytics Department, European Medicines Agency (EMA) An agency of the European Union

2 Agenda The business case for SPOR What will SPOR deliver: RMS, OMS and P&SMS SPOR timelines and benefits NCA and Industry involvement/impacts Key messages 1

3 Business Case for SPOR (1/3) Lack of data standardisation Results in Different names for substances are used across different regions in Europe and globally The same organisation name can be entered differently into various applications Different controlled vocabularies are used across organisations Inconsistent data quality and duplication Inefficiencies relating to correcting data and investigating data discrepancies Decision-making is based on inaccurate information Slower decisionmaking These issues are common across the Agency, NCAs and Industry 2

4 Business Case for SPOR (2/3) Solution is to standardise the data which can be achieved through ISO IDMP standards (five standards) that uniquely identify medicinal product The SPOR projects implements the ISO IDMP standards as well as the processes to manage four domains of data (master data) in pharmaceutical / regulatory industry: Substance Management Services (SMS) Product Management Services (PMS) Organisation Management Services (OMS) Referentials Management Services (RMS) Delivery of SPOR is phased RMS and OMS services were delivered in June 2017 Delivery of PMS and SMS will follow SPOR applies to both domains Human & Veterinary 3 IDMP is not mandated for veterinary products but using a single model brings regulatory efficiency and benefits While the same model will be used across human & veterinary domains it is recognised that not all fields/ rules will be applicable to the veterinary domain

5 Business Case for SPOR (3/3) Goal of SPOR is to centralise the management of pharmaceutical/regulatory master data for Referentials, Organisations, Products and Substances (SPOR) & re-use data to support multiple business cases, eg: E-submissions: Users can use SPOR structured and quality controlled data as input in their initial MA, extensions, variation or renewal applications submitted via eaf as well as CESSP. Regulators perform fewer checks on the data received Variations: The administrative variations could be submitted directly as structured data into the product database and therefore reducing the manual effort for all parties involved (Industry, NCAs and EMA), while improving the quality and reusability of data MRLs: Users can use SPOR structured and quality controlled data as input in their MRL application. Regulators perform fewer checks on the data received Consumption: Users use standardised data on product and their intended animal species. Using the same standardised data to collect also antimicrobial medicines used in animals across the European Union (EU) enables better data collection (data can be re-used) and better data analysis 4

6 What will SPOR deliver? SPOR data is accessible via the SPOR web portal and SPOR API (Application Programming Interface) A specialised team of EMA data stewards will manage SPOR data and provide support to stakeholders.. New process for industry and NCAs to preregister/update SPOR data before submitting regulatory applications. Data is entered once and reused in different processes New data management approaches for industry, NCAs and the EMA: - Data synchronisation on an ongoing basis - Possible need for data transformation/enrichment 5 List of organisations (OMS dictionary), Referentials Lists/Terms and Substances for stakeholders to use in EU regulatory activities

7 RMS & OMS RMS replaces EUTCT and will provide a single source of Lists from different maintenance organisations RMS implements ISO IDMP and standards and provides Lists and Terms of Referentials.. 6 The initial content of the OMS dictionary will derive from Telematics systems i.e. xevmpd Art.57, EudraGMDP and other EMA corporate systems OMS dictionary delivers list of organisations with associated physical locations to support EMA and EU-wide regulatory activities. Dictionary to expand throughout 2017 and 2018

8 PMS & SMS PMS (phase 1) will be the first iteration of ISO IDMP and compatible data management solution for authorised human & veterinary products. It will support generation and maintenance of MPID, PhPID & PCID. To fully address the implementation of IDMP further projects will be required SMS (phase 1) will be the first iteration towards ISO IDMP compatible data management solution for substances. To fully address the implementation of IDMP further projects will be required PMS will provide a central dictionary of EU human & veterinary Authorised medicinal products and, in the future human investigational medicinal products, and provide users with data services 7 SMS will provide a central dictionary of Substance (Human and veterinary) data and provide users with data services

9 SPOR timelines and example of benefits Integrate OMS with eaf RMS is already integrated with eaf (*) Integrate RMS & OMS with CESSP (MAA) (*) ISO IDMP compliant SPOR data services June 2017: EMA invited NCAs to start registering their SPOR users October 2017: EMA will invite Industry to start registering their SPOR users 2018: Benefit of standardised OMS data to support regulatory submissions (eaf/cessp) & data quality. Incremental delivery of Products & Substance Services e.g: integration of product submission and validation with regulatory processes. ISO IDMP compliant RMS & OMS services live June (*) system integration is subject to EMA and Member States resource availability.

10 Industry involvement through SPOR (1/2) At the RMS & OMS go-live there were no immediate changes to submission processes Changes in the current eaf submission processes are being explored to support OMS integration with eaf (planned for December 2017). RMS is already integrated with eaf CESSP MAA is also expected to integrate with OMS & RMS & SMS. There are currently no other envisaged process changes with regards to Product submission by Industry. Any changes arising from the ongoing P&SMS projects are not due before Agency relocation. Detailed plans/impacts will be communicated to veterinary stakeholders after relocation. 9

11 Industry involvement through SPOR (2/2) : 2019 RMS & OMS milestones Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 RMS & OMS Release 2 16 Oct OMS integration with eaf. RMS already integrated Dec RMS & OMS integration With CESSP (*) RMS & OMS Art.57/xEVMPD Integration (*) RMS & OMS CT Portal Integration (*) (for audit, no impact) RMS & OMS use 23 Oct - Industry start registering their SPOR users Can start requesting new/updated data via RMS prior to regulatory submission Can start requesting new/updated data via OMS prior to regulatory submission Programme participation SPOR Programme participation & Engagement via SPOR Change Liaisons **Analyse / adapt process to keep data synchronised *Analyse / adapt systems to support process changes **Synchronise local data with SPOR **Post go live Industry map against new Referential Lists **OMS mapping * Subject to planning ** Only if using/planning to use automated integration with eaf/cessp

12 NCAs involvement through SPOR (1/2) At the RMS & OMS go-live there were no immediate changes to submission processes There could be some changes in the processing of eaf due to eaf integration with OMS (planned for Dec 2017). RMS is already integrated with eaf CESSP MAA is also expected to integrate with OMS & RMS & SMS. NCAs are expected to submit their product data to EudraPharm Vet. NCAs have been requested to continue with the mapping of Referentials and start with the mapping of Organisations in support to PMS implementation. Any changes arising from the ongoing P&SMS projects are not due before Agency relocation. Detailed plans/impacts will be communicated to veterinary stakeholders after relocation. 11

13 NCAs involvement through SPOR (2/2) : 2019 RMS & OMS milestones RMS & OMS use Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 RMS & OMS Release 2 16 Oct NCA start registering their SPOR users OMS integration with eaf. RMS already integrated Dec RMS & OMS integration With CESSP (*) NCAs can start requesting new/updated terms via RMS NCAs can start requesting new/updated data via OMS RMS & OMS Art.57/xEVMPD Integration (*) RMS & OMS CT Portal Integration (*) Programme participation SPOR Programme participation & Engagement via SPOR Change Liaisons **Analyse / adapt process to keep data synchronised **Analyse / adapt systems to support process changes **Synchronise local data with SPOR Continue mapping Referentials (in preparation for PMS) Start OMS mapping (in preparation for PMS) * Subject to planning ** Only if using/planning to use automated integration with eaf/cessp

14 Vet specific considerations Look for synergies with eaf/cessp projects: Integrate data management with regulatory process, do it right the first time Collect data from Industry, have data being validate by NCAs Prioritisation and solutions adapted to the vet sector Data scope: Minimum data entry; what is really needed Vet specificities IDMP: While the same model will be used across human & veterinary domains it is recognised that not all fields/ rules will be applicable to the veterinary domain Be mindfull of scale and resource constraints: 13 Amount of work: Unfeasible for Vet stakeholders to follow-up all developments Technical skills: Not own IT staff; outsourced services make changes more complicated Preparedness: Targeted communication and training

15 Key messages R and O already delivered but no immediate changes to submission processes Some changes foreseen for 2018 due to eaf and CESSP integration with SPOR. Dedicated communications / impacts regarding user registration and eaf integration with OMS will be communicated via eaf and SPOR network of change liaisons EMA invites Industry Stakeholders to start registering their users as of October. There are currently no envisaged process changes with regards to Product submission before Agency relocation EMA is listening! 14

16 SPOR data management services portal 15 SPOR portal is compatible with web browsers Internet Explorer (version 10 and above) and Chrome (version 58 and above)

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18 Disclaimer These PowerPoint slides are copyright of the European Medicines Agency. Reproduction is permitted provided the source is acknowledged.