EudraVigilance Operational Plan
8 June 2018EMA/100194/2018Inspections, Human Medicines, Pharmacovigilance and Committees DivisionEudraVigilance Operational PlanMilestones 2018 to 2020Pharmacovigilance Business Team (agreement)15 March 2018Pharmacovigilance Risk Assessment Committee (PRAC) (agreement)22 March 2018EU Pharmacovigilance Oversight Group (agreement)26 March 2018IT Directors Executive Committee (for information)12 April 2018Telematics Forum (for information)27 April 201830 Churchill Place Canary Wharf London E14 5EU United KingdomTelephone 44 (0)20 3660 6000 Facsimile 44 (0)20 3660 5520Send a question via our website www.ema.europa.eu/contactAn agency of the European Union European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
Table of contentsExecutive Summary . 31. Introduction . 62. Objectives of the EudraVigilance Operational Plan . 83. Key factors and activities that will impact EudraVigilance: 2018 to 2020 83.1. EudraVigilance: system maintenance . 93.2. EudraVigilance: integration with the Agency’s identity and access management (IAM2)project . 103.3. United Kingdom withdrawal from the Union . 113.4. Agreement on mandatory use of E2B(R3) in EEA . 123.5. EudraVigilance: use of ISO IDMP standards . 123.6. EudraVigilance: Monitoring and signal management. 133.7. EudraVigilance and ICSR data quality review . 143.8. EudraVigilance and the General Data Protection Regulation (GDPR) . 163.9. EudraVigilance Clinical Trial Module (EVCTM) and SUSAR reporting in accordance withthe Clinical Trial Regulation . 173.10. EudraVigilance: Medical Literature Monitoring (MLM) service . 183.11. GVP Module VI (revision 3) . 183.12. EudraVigilance and benefits realisation . 193.13. EudraVigilance and operation of pharmacovigilance . 203.14. Training and support . 213.15. Stakeholder engagement and communication . 21EudraVigilance Operational PlanEMA/100194/2018Page 2/22
Executive SummaryEudraVigilance is the central pillar for pharmacovigilance activities in the European Economic Area(EEA). In February and April 2017, the new EudraVigilance system successfully passed an independentaudit in accordance with Article 24 of Regulation (EC) 726/2004. The EMA Management Boardconfirmed on 22 May 2017 that the full functionality of the EudraVigilance database had been achievedand the system met the defined functional specifications 1. The new EudraVigilance system waslaunched on 22 November 2017, providing enhanced functionalities to national Competent Authorities(NCAs), EMA and marketing authorisation holders (MAHs) for effective reporting and monitoring ofsuspected adverse reactions and detection of risks related to the safety of medicines, thus contributingto the protection and promotion of public health. Furthermore, EudraVigilance facilitates the safetyreporting of suspected unexpected serious adverse reactions (SUSARs) to investigational medicinalproducts occurring during clinical trials.This operational plan has been prepared upon request by the Pharmacovigilance Risk AssessmentCommittee (PRAC), which is overseeing the operation of EudraVigilance. The operational plan describeskey activities and developments that will impact on or relate to EudraVigilance and its stakeholdersduring the next three years from 2018 to 2020.The plan’s objective is to outline technical as well as operational activities with anticipated timelinesand to highlight how EudraVigilance and the stakeholders that interact with the system will be affected.This should facilitate planning by the Agency, which is operating EudraVigilance on behalf of thenetwork and ensure timely preparedness of NCAs, MAHs, commercial and non-commercial sponsors ofclinical trials and the WHO Uppsala Monitoring Centre.The goal is to ensure sustainability of EudraVigilance and associated activities in support of the EUpharmacovigilance activities and the protection of public health.In addition, the interaction with stakeholders as part of training and support as well as communicationand engagement are covered to ensure that a platform for learning, cooperation, dialogue andalignment throughout the evolution and operation of EudraVigilance system is provided for.This plan will be updated regularly as regards timelines and new activities/developments.A summary of the milestones from 2018 to 2020 is provided in Chart 1.1http://www.ema.europa.eu/docs/en GB/document e Operational PlanEMA/100194/2018Page 3/22
ID1234EudraVigilance Operational PlanEV ICSR (PHV-6775)(enhanced download functionality)7EV/EVDAS maintenance release8EV/EVDAS maintenance release9EV/EVDAS maintenance release10EV/EVDAS maintenance releaseChange Management Plan14Communications to stakeholders15Training and go-live support16Organisation & account freeze17EudraVigilance unavailability18Go-live- EMA accounts and logininterface releaseAnalysis of potential changes21Resource planning to implementchanges22Change management TBC25Q2Q3Q4Q1Q2Q3Q4Q1TBCUK withdrawal from the Union2024Q1Integration – Identity and AccessManagementDevelopment & testing& accountmigration1323Q42021EudraVigilance/EVDAS maintenancereleasesEV Art57 (SD-80687) (Master FileLocation value selection619Q32020EudraVigilance hypercare releasesEVDAS major maintenance release12Q22019EudraVigilance Hypercare5112018Mandatory use E2B(R3)Agreement on mandatory use ofE2B(R3) in EUUse of IDMP standards26XEVMPD OMS and RMS integration27SPOR transition phase 128SPOR transition phase 2Chart 1 (part 1): EudraVigilance Operational Plan Milestones 2018 to 2020EudraVigilance Operational PlanEMA/100194/2018Page 4/22
ID1EudraVigilance Operational PlanSignal Management Pilot3Signal Management Pilot ReportReview of data quality review criteria6Compliance monitoring reports891011121314Drafting of revision 319Public consultation (draft revision 3)20Finalisation of revision 321Publication of revision 326Q4Q1Q2Q3Q4Q1GVP Module VI Revision 31825Q3Medical literature monitoringPreparation of tender for MLM services24Q2EVCTM and SUSAR re-routing toconcerned Member StatesTransition period – 3years followingapplication of Clinical Trial Regulation1623Q1Q&As -guidance on safety reportingReview of substances and literaturesubject to MLM services22Q42021Preparation of tender for qualityreview servicesGDPR - implications on ICSR reporting inEU & feedback from NCAs and MAHsGDPR and ICSR reporting – feedbackfrom NCAs and MAHs/sponsorsSUSAR reporting & Clinical TrialsRegulation1517Q32020Data Quality Review57Q22019Signal Management242018EudraVigilance Benefits RealisationEC report on activities of MSs and EMAto monitor the safety of medicinesEudraVigilance and operation ofpharmacovigilanceQ&As on technical and operationalaspectsGuidance on operational issues asneededChart 1 (part 2): EudraVigilance Operational Plan Milestones 2018 to 2020EudraVigilance Operational PlanEMA/100194/2018Page 5/22
ID1EudraVigilance Operational PlanFace-to-face training offerings (as pertraining calendar)3Training videos (update or new videos)4EVDAS training for NCA users678910Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Training and support25Q22021202020192018EV and EVDAS support webinars (as perwebinar calendar)Stakeholder engagement andcommunicationIndustry platform meetings on theoperation of EU pharmacovigilanceAnnual Stakeholders forum on thepharmacovigilance legislationEV/Signal Management InformationDays (as per EMA event calendar)Pharmacovigilance Newsletter (biannually)Chart 1 (part 3): EudraVigilance Operational Plan Milestones 2018 to 20201. IntroductionEudraVigilance is the system for managing and analysing information on suspected adverse reactionsto medicines which have been authorised or are being studied in clinical trials in the EuropeanEconomic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of theEuropean Union (EU) medicines regulatory network. The Pharmacovigilance Risk AssessmentCommittee (PRAC) as part of the pharmacovigilance governance provides oversight of the operation ofthe system and its functionalities.In February and April 2017, the new and enhanced EudraVigilance system successfully passed anindependent audit in accordance with Article 24 of Regulation (EC) 726/2004. The EMA ManagementBoard confirmed on 22 May 2017 that the full functionality of the EudraVigilance database had beenachieved and that the system met the defined functional specifications 2. The new EudraVigilancesystem was launched on 22 November 2017, providing improved functionalities to national CompetentAuthorities (NCAs), EMA and marketing authorisation holders (MAHs) for effective reporting andmonitoring of suspected adverse reactions and detection of risks related to the safety of medicines,thus contributing to the protection and promotion of public health. Furthermore, EudraVigilancefacilities the safety reporting of suspected unexpected serious adverse reactions (SUSARs) toinvestigational medicinal products occurring during clinical trials by commercial and non-commercialsponsors.An overview of the EudraVigilance system components is provided in figure 1, with further informationprovided on the dedicated EudraVigilance system overview webpage.2http://www.ema.europa.eu/docs/en GB/document e Operational PlanEMA/100194/2018Page 6/22
Figure 1: EudraVigilance system componentsBy the end of 2017, EudraVigilance held information on more than 12.45 million safety reports,referring to 7.95 million cases, as well as information on 744,219 medicinal products on the EUmarket. EudraVigilance is being used for regular signal detection by EMA and NCAs and in support ofother pharmacovigilance procedures in terms of data analysis. Furthermore, making all ICSRs from theEEA available to the World Health Organisation (WHO) Uppsala Monitoring Centre (UMC) directly fromEudraVigilance facilitates global pharmacovigilance activities.Access to EudraVigilance for MAHs was initiated at the end of 2017, to allow MAHs to comply with theirsafety monitoring obligations. Improved access to EudraVigilance data is also being provided forhealthcare professionals, the public and academia. With the simplifications in reporting of suspectedadverse reactions and improvements in the tools for their analysis and monitoring, EudraVigilance iscontributing to optimising the benefit-risk balance of medicines and thus to the protection andpromotion of public health.The key areas supported by EudraVigilance can be summarised as follows: Collecting and processing of adverse drug reaction reports. Maintaining and updating the extended EudraVigilance Medicinal Product Dictionary (XEVMPD)based on information on all medicinal products authorised in the EU. Ongoing data quality activities, detecting and managing duplicate reports and classification ofreported medicinal product informatin. Production and provision of data analysis reports on medicines safety to the EU network (electronicreaction monitoring reports - eRMRs) and provision of data analyses to support assessments inpharmacovigilance procedures. Supporting the central role of the PRAC in assessing and monitoring the safety of human medicinesin the EU, including prioritising and assessing safety signals. Signal management and monitoring of the data available in EudraVigilance by MAHs.EudraVigilance Operational PlanEMA/100194/2018Page 7/22
Continued public access to aggregated EudraVigilance data (www.adrreports.eu). Making available ADR reports originating from the EEA to the WHO-UMC.The Agency is also delivering training courses on EudraVigilance to support users of NCAs, MAHs andsponsors of clinical trials. Training includes targeted e-learning and face-to-face trainings, webinarsand information days.The Pharmacovigilance News Letter provides regular updates on important pharmacovigilance topicsincluding EudraVigilance related activities.2. Objectives of the EudraVigilance Operational PlanThe EudraVigilance operational plan has been prepared upon request by the PRAC, which is overseeingthe operation of EudraVigilance in the context of the overall monitoring of the safety of medicinesthroughout their life-cycle.The plan is designed to describe key factors that will impact on EudraVigilance and its stakeholdersfrom a technical and operative perspective during the next three years from 2018 to 2020.The plan’s objective is to outline important activities and developments with anticipated timelines andto highlight how EudraVigilance and the stakeholders that interact with the system will be affected.This should facilitate adequate planning by the Agency, which is operating EudraVigilance on behalf ofthe EU medicines regulatory network and ensure timely preparedness of NCAs, MAHs, commercial andnon-commercial sponsors of clinical trials and the WHO Uppsala Monitoring Centre.The goal is to ensure sustainability of EudraVigilance in support of the EU pharmacovigilance activitiesand the protection of public health taking into account the evolving environment in which the system isoperated.In addition, the interaction with stakeholders as part of training and support as well as communicationand engagement are covered to ensure that a platform for learning, cooperation, dialogue andalignment throughout the evolution of the EudraVigilance system is provided for.This plan will be updated regularly as regards timelines and timelines or new activities/developments.3. Key factors and activities that will impact EudraVigilance:2018 to 2020The following chapters outline key factors and activities that relate to or that will impact onEudraVigilance directly or indirectly from 2018 to 2020.It should be noted that the activities outlined in this plan for 2018 onwards have beenscheduled considering the respective business priorities, as well as the Agency’s relocationas a result of the UK’s exit from the EU and its impact on the Agency’s business continuity,and may be subject to further review and reprioritisation in accordance with the businesscontinuity plan of the Agency.EudraVigilance Operational PlanEMA/100194/2018Page 8/22
3.1. EudraVigilance: system maintenanceFollowing the delivery of the new and enhanced EudraVigilance system, EudraVigilance is currentlysubject to “hypercare”, a stabilisation period focusing on user support, data integrity, and systemstability. This stabilisation period will end in May 2018 after which the system will be subject to routineIT maintenance. Bug fixes and minor improvements will be subject to planned maintenance releaseswith minimal downtimes. Release notes will provide a summary for each maintenance release and willbe published on the EudraVigilance training and support webpage.Requests for improvements in relation to EudraVigilance system functionalities are being dealt inaccordance with the change requests management process for Telematics systems overseen by theTelematics Change Management Board as part of the EU Telematics governance (Figure 2).Figure 2: Telematics Governance ModelGiven the Agency’s preparation for its relocation to Amsterdam, there are several relocation-criticalprojects and initiatives that have been prioritised during 2018 and 2019. This will significantly reducethe implementation of changes to existing Telematics applications including EudraVigilance during thenext 18 months focusing on those which are flagged as business critical. During 2019, developmentwork on existing applications and implementation of change requests will resume taking into accountplanning, relative prioritisation and spare capacity.For 2018 to 2020, the following releases and activities are scheduled: From March to May 2018 (hypercare period), two releases are scheduled per month to allow forfinal fixes of identified issues. In the 2nd quarter of 2018, a maintenance release is planned for the XEVMPD to allow for anupdate of the Master File Location (MFL) values. In addition, a maintenance release of EV isplanned for to further improve the ICSR download functionality. For EVDAS, a major maintenancerelease is planned for May 2018. For 2019 to 2020, two maintenance releases for EudraVigilance/EVDAS are currently planned. The EudraVigilance Veterinary system, which is using certain components of EudraVigilanceHuman, will be subject to upgrades in 2019 following a design phase in 2018. These upgrades mayEudraVigilance Operational PlanEMA/100194/2018Page 9/22
require downtimes, which could also impact on EudraVigilance Human. Users will be informedwhere this might impact the availability of the system components of EudraVigilance Human.ID1234TextOperational 21Q3Q4Q1EudraVigilance HypercareEudraVigilance hypercare releasesEudraVigilance/EVDAS maintenancereleasesEV Art57 (SD-80687) (Master FileLocation value selection5EVDAS major maintenance release6EV ICSR (PHV-6775)(enhanced download functionality)7EV/EVDAS maintenance release8EV/EVDAS maintenance release9EV/EVDAS maintenance release10EV/EVDAS maintenance releaseTBCChart 2: EudraVigilance system maintenance - milestones 2018-20203.2. EudraVigilance: integration with the Agency’s identity and accessmanagement (IAM2) projectThe Agency’s Identity and Access Management (IAM2) project aims to simplify the registration andmanagement of EudraVigilance organisations and users from a business process and technology pointof view. As part of the project, the EudraVigilance platform will be integrated with twoservices/platforms already put in place by the Agency: the EMA Account Management Portal and theOrganisation Management Services (OMS).Existing EudraVigilance organisations will be on-boarded in OMS. This will have no impact on theorganisation identifiers currently in use by sender organisations.In addition, the EudraVigilance applications (EVWEB, EVDAS, XEVMPD) will be updated to use the EMAAccount already in use by other EU Telematics applications, such as EudraLink and EudraGMDP. Newworkflows will be put in place to enable EudraVigilance users to self-manage their access through theEMA Account Management Portal.A change management plan will provide organisations and users with an overview of the timelines forthe switch and explain the transition and data migration approach. Testing will be scheduled withvolunteers from different stakeholder groups. Online training on the use of the new registrationinterface will also be offered.For 2018 the following activities and milestones are scheduled: Development and testing of the new functionalities integrated with EudraVigilance includingaccount management.EudraVigilance Operational PlanEMA/100194/2018Page 10/22
Publication of Change Management Plan. Communication with stakeholders and provision of training and support. Go-Live (EV downtime as part of the deployme
clinical trials and the WHO Uppsala Monitoring Centre . The goal is to ensure sustainability of EudraVigilance and associated activities in support of the EU pharmacovigilance activities and the protection of public health. In addition, the interaction with stakeholders as part of training and support as well as communication
EudraVigilance - EVWEB User Manual EMA/501718/2018 Page 5/103 1. Introduction 1.1. About this User Manual This user manual is part of the official documentation prepared by the European Medicines Agency (EMA) to support the use of the EudraVigilance Web reporting tool EVWEB.
This go-live plan outlines a set of detailed, sequenced tasks and activities required to lau nch the new EudraVigilance production system including the migration of more than 11 million Individual Case Safety Reports (ICSRs) and associated data and the decommissioning of the current (legacy)
The Agency's Identity and Access Management (IAM2) project aims to simplify the registration and management of . EudraVigilance. organisations and users from a business process and technology point of view. As part of the project, the Eu draVigilance platform will be integrated with two
rules and validation steps as described in the 'Note for Guidance EudraVigilance Human - Processing of Safety Messages and Individual Case Safety Reports (ICSRs)' (Doc. Ref. EMA/H/20665/04/Final, Revision 1). The following aspects are outlined in detail: The mandatory electronic reporting essentials
Section 9 User manual of the eRMR for MAHs. The references to the ad-hoc eRMR have been deleted. The SDR criteria implemented in EV has been further emphasised. 17 Feb 2021 2.1 New section (9.10.) added to reflect the changes in the EVDAS outputs triggered by the Brexit implementation in EudraVigilance.
All training modules can be accessed via the EudraVigilance Training Page. EMA Website - Human Regulatory - Pharmacovigilance - EudraVigilance - Training page The e-learning modules are listed as clickable links in the table at the top of the webpage in a navigable table. PhV-M0 Introduction to training offering by the EMA
EMA Service Desk Portal EudraVigilance, Technical or application-specific queries EMA Service Desk portal: https://servicedesk.ema.europa.eu Urgent Technical Helpline Urgent technical or application-specific queries Urgent technical helpline: 44 (0)20 3660 8520 Ask EMA Pharmacovigilance-related or General Queries Ask EMA:
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