SPOR for VETERINARY EU Network Data Board / SPOR Task Force 29, 30 June – 1 July 2016 Presented by: Jos Olaerts Veterinary Division
Content Draft Veterinary regulation and SPOR • Feedback from the Veterinary SPOR Webinar (22 June) • Status of Veterinary SPOR and way forward • 1 SPOR for VETERINARY
Draft Veterinary Regulation Published Sept 2014 European Parlement: COM AGRI & ENVI adopted opinion/report EP PLENARY on 10 March 2016 - mandate to enter into inter- institutional negotiations on VMPs Council discussions ongoing – slow Anticipated adoption – 2017? Anticipated implementation – 2019? 2 SPOR for VETERINARY
EUTMB adoption First Vet IT Roadmap 2014 2015 2016 2017 2018 2019 Publication Anticipated adoption Implementation Draft Vet Regulation Vet Regulation EMA Vet IT EU Telematics’ EU Telematics’ Roadmap Projects Projects following - Planning Execution analysis draft - Initiation regulation 3 SPOR for VETERINARY
Main systems affected by legislation Union Pharmaco- vigilance system Electronic submission Union Database for Products Union EMA Database on Workflow Manufacturing and Wholesale system distribution Sales and use data for antimicrobials 4 SPOR for VETERINARY
5 distinct but interlinked Vet IT Data systems identified from requirement analysis of draft regulation 5 SPOR for VETERINARY
Non - EMA Data and System related topics Clinical trials Tracker for national marketing authorisations Website regarding sales at a distance 6 SPOR for VETERINARY
Product Database System (EMA Perspective) 2019 Integrate with GMP/Certificates database G1 G2 G3 (Art. 51 (2a)) Vet specific EU VET MED PROD DATABASE (ex-Eudrapharm) G1 G2 G3 development and integration with SP or EMA common Integrate with e-submission (including Art. G1 G2 G3 60 (1) direct MAH update of variation) Integrate with sp O r G1 G2 G3 Integrate with spo R G1 G2 G3 Update of product index generation and recoding G1 G2 G3 application (as done for Art.57 human data) G1 G2 G3 ID and Access Management Project elematics projects = Driven by legislation 7 SPOR for VETERINARY
Union Pharmacovigilance system 2019 Implement VICH data/message model – G1 G2 G3 EVVET3 Vet specific VPhS update – Integration with EV Signal G1 G2 G3 Management Project EMA common Implement Access Policy G1 G2 G3 (same as EVHuman implementation) Integrate with s P or G1 G2 G3 Establish link to spo R G1 G2 G3 ID and Access Management Project G3 G1 G2 elematics projects = Driven by legislation 8 SPOR for VETERINARY
Union Database on Manufacturing and Wholesale Distribution 2019 Integrate with Product database G1 G2 G3 (Art. 51 (2a)) Vet specific Allow export certificates uploads and G1 G2 G3 publishing (Art. 103) EMA common Integrate with sp O r G1 G2 G3 Integrate with spo R G1 G2 G3 ID and Access Management Project G1 G2 G3 elematics projects = Driven by legislation 9 SPOR for VETERINARY
Electronic submission 2019 CESSP: E-submission / gateway G2 G3 G1 integration project ( SPOR compatible) EMA common Common repository G1 G2 G3 (for vet applications) Integration with SIAMED G1 G2 G3 ID and Access Management Project G1 G2 G3 elematics projects = Driven by legislation 10 SPOR for VETERINARY
System for the supervision of use and sales of antimicrobials 2019 Upgrade existing system to collect use G1 G2 G3 data stratified by species Vet specific EMA common Allowing s P or referencing G1 G2 G3 ID and Access Management Project G3 G1 G2 11 SPOR for VETERINARY
Feedback from the Veterinary SPOR Webinar (22 June) 12 SPOR for VETERINARY
High level programme timelines • The focus for 2016 is on implementation of Referentials and Organisations • Referentials and Organisations will lay the data foundations for Products & Substances 13 SPOR for VETERINARY
Roll out plan Ongoing conversations with other programmes. Benefits will be released incrementally through each iteration within SPOR and through integration with other EU programmes. This roll-out plan demonstrates the drivers behind the timing of SPOR implementation activities. It also sets out critical supporting activities required from NCAs and Industry, specifically relating to RMS and OMS 2016 2017 2018 2019 NCA & Industry Activities Programme participation Actively participate in SPOR Programme forums, information sharing, planning, UAT and change management Follow through on Establish and embed Change Liaisons Actively use R & O data services, enforce R & O operating models commitments Undertake R & O data mapping, submit Data mapping Submit data change requests and synchronise R & O data on an ongoing basis data change requests and synchronise data The next section of this deck Process changes Identify and adapt impacted processes relating to RMS and OMS provides more detail about each set of activities, specifically 14 SPOR for VETERINARY System changes relating to RMS and OMS Identify and adapt impacted systems relating to RMS and OMS
Referentials Operating Model EMA will act as the broker • EMA will provide referential data services to EU network – Referentials data maintained by EMA Data Stewards and available in structured format • EMA will host reference lists from different maintenance organisations (WHO, EDQM, MSSO, BFARM, etc) – EDQM: maintenance organisation for ISO IDMP 11239 (ph. forms, units of presentation, routes of administration, packaging) – BFARM: maintenance organisation for Units of Measurement (ISO IDMP 11240) • EMA will be a maintenance organisation for new lists where no maintenance organisation exists • Common process which requires industry and other parties to request term registration before regulatory submission • Translations done by NCAs • All organisations need to register legacy & specific terms with EMA • This model provides for a global forum, but this aspect is yet to be discussed 15 SPOR for VETERINARY 15
RMS data flow - regulatory context SPOR for VETERINARY 16
OMS dictionary at go live and how it will be expanded with organisations data OMS Live Q4 2016 Q1 2017 Q3 2017 Q4 2017 2018 / 2019 TBD: CROs; CT site; Academia; Hospitals; Distributers etc. Sponsors Manufacturers: (H+V) CAPs • MAHs: (H+V) CAPs & (H) NAPs Regulatory Authorities/NCAs Manufacturers: (H+V) NAPs • MAAs: (H+V) CAPs • MRL applicants (Vet) • MA & MRL contacts : (H+V) CAPs 17 SPOR for VETERINARY
OMS Operating Model – Phase I Phase I - Organisations Operating Model – Implemented as part of the first OMS project Scenario applicable when the regulatory submission takes place with an NCA Pre-Registration of Organisation in the EU Organisation Hub Applications/information sent as part of regulatory activities Request Industry Organisation registration or Submit application update Message containing: NCA_org_ID & <EU_Loc_ID> EU_Loc_ID and <Organisation data> organisation data <Other IDs> (& other IDs) etc. If not registered, assign NCA_org_ID and validate EU_Loc_ID and against EU_Loc_ID organisation data (& NCA other IDs) Request for organisation registration or update EU_Loc_ID and organisation data (& other IDs) Register and issue EU_Loc_ID & Org_ID EMA Request for organisation registration or update Publish data in the MDM (EU Hub) organisation dictionary 18 SPOR for VETERINARY
Update on the UAT activities High level UAT approach drafted and agreed with SPOR Task • Force. It envisages wide stakeholder participation Appointment of testers almost completed • Following stakeholder groups are represented: • • Industry provided a list of testers representing Industry and Vendors • NCAs list of testers has been collated • Veterinary Industry and Vendors are not yet represented Next steps: • Plan TCs/Webinars to on-board all testers • Review of Test Cases and UAT plan • Confirm UAT dates • 19 SPOR for VETERINARY
EU VET MED PROD DATABASE UNION DATABASE (Eudrapharm Vet) (revised legislation) Released in February 2015 Available from 2018 ? To be live until 2020->? Integration of veterinary medicines within ongoing EU Telematics project on SPOR Part of database system feeding product SPOR (ISO-IDMP) compliant system data into EVVET allowing DWH analysis Objective: EU wide Signal detection Objective: serving all requirements for all EU veterinary medicinal products. identified by legislation Direct submission by Member States Direct submission by Member States for the legacy data Integrated with other systems, e.g. Electronic submission by MAHs allowing direct data input by MAH for e.g. new applications or variations. 20 SPOR for VETERINARY
First business objective: allowing signal management at EU level (Requested by HMA/ESS by letter to ExDir EMA in 2013) Discrepancy between EU surveillance level for Veterinary CAPs (periodic signal detection in place) and non CAPs (no EU wide analysis possible, because of lack of product data to cross link with adverse event data). Specifically affecting smaller Member States who only have access to limited local adverse event data. Required data: National Product Data AS APPROVED – NO NEED FOR PRIOR STANDARDISATION – Signal detection runs 95% on the basis of VEDDRA coding within the adverse events. 21 SPOR for VETERINARY
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