EudraVigilance Go-Live Plan - European Medicines Agency
13 October 2017EMA/399493/2017 Revision 1Inspections, Human Medicines Pharmacovigilance & CommitteesEudraVigilance Go-Live PlanSteps to be followed by national competent authorities, marketingauthorisation holders and sponsors of clinical trials in the EEAPharmacovigilance Business Team (for consultation)18 July – 11 August 201722 August 201728 August 2017Clinical Trial Facilitation Group (CTFG)- Subgroup H (for consultation)26 July – 11 August 2017Pharmacovigilance Risk Assessment Committee (PRAC) (for26 July – 11 August 2017consultation)1 September 201714 September 2017Pharmacovigilance Risk Assessment Committee (PRAC)1 September 2017(endorsement)Clinical Trial Facilitation Group (CTFG) (endorsement)5 September 2017EudraVigilance Expert Working Group (for consultation)15 September 2017IT Directors (for information)15 September 2017EU Telematics Management Board (EUTMB) (for information)18 September 2017EU Pharmacovigilance Oversight Group (EU-POG) (for information)18 September 201730 Churchill Place Canary Wharf London E14 5EU United KingdomTelephone 44 (0)20 3660 6000 Facsimile 44 (0)20 3660 5555Send a question via our website www.ema.europa.eu/contactAn agency of the European Union European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Table of contentsVersions . 41. Executive summary . 52. Introduction . 63. Stakeholders . 74. EudraVigilance pre-cutover activities . 94.1. ADR reporting (pharmacovigilance) – interim arrangements . 94.2. SUSAR reporting – clinical trials . 94.3. Medical literature monitoring (MLM) by the Agency . 94.4. Data submission on medicines to the XEVMPD . 94.5. Signal management NCAs and EMA . 94.6. EudraVigilance registration of organisation/users. 104.7. Interoperability testing with the new EudraVigilance XCOMP (test) environment . 104.8. Adrreports.eu portal . 104.9. EudraVigilance go-live rehearsal by EMA . 115. EudraVigilance cutover activities . 135.1. ADR reporting (pharmacovigilance) . 205.1.1. ADR reporting - option 1 during cutover period . 205.1.2. ADR reporting - option 2 during cutover period . 285.1.3. ADR reporting - option 3 during cutover period . 355.2. SUSAR reporting – clinical trials . 435.2.1. SUSAR reporting - option 1 during cutover phase . 435.2.2. SUSAR reporting - option 2 during cutover phase . 475.2.3. SUSAR reporting - option 3 during cutover phase . 535.3. Medical literature monitoring (MLM) by the Agency . 575.4. Data submission on medicines to the XEVMPD . 575.5. Signal Management by NCAs and EMA . 575.6. Adrreports.eu portal . 585.7. Interoperability testing with the new EudraVigilance XCOMP (test) environment . 586. EudraVigilance cutover legacy activities . 586.1. ADR reporting (pharmacovigilance) - legacy activities from cutover period . 596.2. SUSAR reporting from clinical trials - legacy from cutover period . 616.3. Medical literature monitoring (MLM) by the Agency . 636.4. Data submission on medicines to the XEVMPD . 636.5. Signal management . 646.6. EudraVigilance registration of organisation/users. 646.7. Interoperability testing with the new EudraVigilance XCOMP (test) environment . 646.8. Adrreports.eu portal . 647. EudraVigilance go-live production phase . 657.1. Go-live timing . 657.2. ADR reporting (pharmacovigilance) – simplified reporting rules . 667.3. SUSAR reporting – clinical trials (current reporting rules) . 68EudraVigilance Go-Live PlanEMA/399493/2017Page 2/70
7.4. Medical literature monitoring (MLM) by the Agency . 697.5. Data submission on medicines to the XEVMPD . 697.6. Use of EVDAS/eRMRs by NCAs, EMA and MAHs . 697.7. EudraVigilance registration application and registration of organisation/users . 697.8. Interoperability testing with the new EudraVigilance XCOMP (test) environment . 70EudraVigilance Go-Live PlanEMA/399493/2017Page 3/70
VersionsDateVersion number3 October 201713 October 2017Summary of changesOriginal document.1.0The first revision of the document has been carried out toinclude a clarification on the Paul-Ehrlich Institute’s adversereaction reporting arrangements during the EudraVigilancecutover period.EudraVigilance Go-Live PlanEMA/399493/2017Page 4/70
1. Executive summaryThe European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, theEuropean information system of suspected adverse reactions to medicines that are authorised or beingstudied in clinical trials in the European Economic Area (EEA).Following the EMA Management Board confirmation and announcement in May 2017 that the databasehas achieved full functionality, the new version of EudraVigilance will go live on 22 November 2017with enhanced functionalities for reporting and analysing suspected adverse reactions. The publichealth benefits from the new system and operational benefits for stakeholders and regulators willprovide a robust basis for pharmacovigilance and signal management activities for years to come, so itis important that care is taken in transitioning from the current to the new database.This go-live plan outlines a set of detailed, sequenced tasks and activities required to launch the newEudraVigilance production system including the migration of more than 11 million Individual CaseSafety Reports (ICSRs) and associated data and the decommissioning of the current (legacy)EudraVigilance system as regards the ICSR reporting and processing functionalities. To allow for asmooth transition from the current to the new EudraVigilance system, a cutover (downtime) period of10 business days i.e. from 8 to 21 November 2017 is required, where key functionalities ofEudraVigilance will not or only partially be available.During the cutover period, the electronic reporting of ICSRs by national competent authorities(NCAs), marketing authorisation holders (MAHs) and sponsors of clinical trials (sponsors) will bedisrupted. The electronic submissions of data on medicines (Article 57) will be unavailable.Signal management by NCAs and EMA will be impacted to a small extent, as the current EVDASwill be kept operational until 21 November with a last data refresh to be performed on 7 November2017.The adrreports.eu portal website will remain live, based on the latest monthly data refresh of 31October 2017.The reporting by patients and healthcare professional to national competent authorities(NCAs) and marketing authorisation holders (MAHs) in the EEA will not be impacted duringthe cutover phase to the new EudraVigilance system.This go-live plan further describes the stakeholders impacted and sets out the technical and businessprocess related aspects as well as alternative arrangements for reporting of ICSRs that need to beplanned for by stakeholders to ensure a successful transition. Procedures are in place for urgentreporting of important safety information and are reiterated in this go-live plan.The Agency has carefully considered a number of options, all of which require some downtime and hasselected that of 10 business days since shorter times carried higher technical risk that the processwould take longer than planned and either would have to be rolled back or would risk the new systemgoing life after 22 November 2017.After the 22 November 2017, the current EudraVigilance System will remain operational but restrictedto the functionalities related to the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)and the electronic data submission on medicines (Article 57).EudraVigilance Go-Live PlanEMA/399493/2017Page 5/70
2. IntroductionThe European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, theEuropean information system of suspected adverse reactions to medicines that are authorised or beingstudied in clinical trials in the European Economic Area (EEA). The new version of EudraVigilance willgo live on 22 November 2017 with enhanced functionalities for reporting and analysing suspectedadverse reactions.An independent audit and a subsequent favourable recommendation from EMA’s PharmacovigilanceRisk Assessment Committee (PRAC) concluded that the updated EudraVigilance system is fullyfunctional. Therefore, pursuant to Article 24(2) third subparagraph of Regulation (EC) No 726/2004,EMA’s Management Board confirmed and announced that the EudraVigilance database has achieved fullfunctionality and the system meets the functional specifications. Together with the launch, further legalobligations will become applicable to the mandatory electronic reporting through EudraVigilance asstated in the announcement of the EMA Management Board.The enhancements for reporting and analysing suspected adverse reactions of the new EudraVigilancesystem will support better safety monitoring of medicines and a more efficient reporting process forstakeholders. Expected benefits include: Simplified reporting of individual case safety reports (ICSRs) and the re-routing of ICSRs toMember States as marketing authorisation holders will no longer have to provide these reports tonational competent authorities, but directly to EudraVigilance, which will ultimately reduceduplication of efforts. An ICSR provides information on an individual case of a suspected adversereaction to a medicine; Better detection of new or changing safety issues, enabling rapid action to protect public health; Increased transparency based on broader access to reports of suspected adverse reactions byhealthcare professionals and general public via the adrreports.eu portal, the public interface of theEudraVigilance database; Enhanced search and more efficient data analysis capabilities;Increased system capacity and performance to support large volumes of users and reports(including non-serious adverse reactions originating from the EEA); More efficient collaboration with the World Health Organization (WHO) as EMA will make thereports of individual cases of suspected adverse reactions within the EEA available to the WHOUppsala Monitoring Centre directly from EudraVigilance; Member States will no longer need tocarry out this task.The reporting of adverse reactions by patients and healthcare professionals to national competentauthorities based on local spontaneous reporting systems will remain unchanged. There will also be nochanges to the reporting of suspected unexpected serious adverse reactions during clinical trials untilthe application of the new Clinical Trial Regulation.Users of the system, i.e. national competent authorities, marketing authorisation holders and sponsorsof clinical trials, have to make final preparations to ensure that their processes and local ITinfrastructure are compatible with the new system and the internationally agreed format. A technicalsupport plan and checklist for national Competent Authorities in the EEA as well as marketingauthorisation holders and sponsors of clinical trials in support of the go-live of the enhancedEudraVigilance System were published in June 2017.EudraVigilance Go-Live PlanEMA/399493/2017Page 6/70
This go-live plan outlines a set of detailed, sequenced tasks and activities required to launch the newEudraVigilance production system including the migration of more than 11 million ICSRs andassociated data and the decommissioning of the current (legacy) EudraVigilance system for ICSRreporting and data analysis.In addition, it defines the stakeholders impacted and sets out the technical and business processrelated aspects that need to be planned for by stakeholders to ensure a successful cutover.A successful cutover will be achieved through: Execution of the go-live plan with the aim of minimal impact on the daily business activities ofstakeholders; Co-ordination of all technical and business process related changes and alternative arrangementsassociated with putting the new EudraVigilance system into operation; Execution of the go-live plan within the established timeframes.Chart 1 outlines the key areas of activities of this go-live plan and the EudraVigilance changeoverstrategy. Each of the key areas is further described in the following chapters with an outline of theactivities to be carried out by concerned stakeholders.3. StakeholdersAs part of the go-live planning strategy, the following stakeholders will be impacted:Stakeholder GroupAcronymEuropean Medicines AgencyEMANational Competent Authorities in the European Economic AreaNCAsMarketing Authorisation HoldersMAHsGeneral publicPublicSponsors of clinical trialsSponsorsWorld Health Organisation - Uppsala Monitoring CenterWHO-UMCEudraVigilance Go-Live PlanEMA/399493/2017Page 7/70
IDTask NameStartFinishDuration1EudraVigilance pre-cutover activities15/09/201722/01/201892d2EudraVigilance cutover activities08/11/201721/11/201710d3EudraVigilance go-live22/11/201722/11/20170d4EudraVigilance cutover legacy22/11/201724/11/20173d5EudraVigilance post-go-live22/11/201722/11/20170dSep 20173/910/917/9Oct 201724/91/10Nov 2017Dec 20178/10 15/10 22/10 29/10 5/11 12/11 19/11 26/11 3/12 10/12 17/12 24/12 31/12Jan 20187/114/121/128/1Chart 1: Key areas of activities of this go-live plan and the EudraVigilance changeover strategy (Note: duration is indicated in business days excludingweekends)EudraVigilance Go-Live PlanEMA/399493/2017Page 8/70
4. EudraVigilance pre-cutover activitiesPrior to the initiation of the EudraVigilance cutover period, the present business processes related tothe use of the current EudraVigilance system will continue as is. Testing activities with the newEudraVigilance XCOMP (test) environments can also continue with the exception of the 18 to 20September 2017 and the week of 23 to 27 October 2017. The Gateway will not be available on 23September 2017 due to software upgrades. The activities as part of the EudraVigilance pre-cutoverphase and associated timelines are summarised in chart 2 and are further outlined below.4.1. ADR reporting (pharmacovigilance) – interim arrangementsPrior to the initiation of the EudraVigilance cutover period the following applies: NCAs and MAHs in the EEA report suspected adverse reactions in accordance with the presentlyapplied interim arrangements as set out in the Guideline on good pharmacovigilance practices(GVP) Module VI – Management and reporting of adverse reactions to medicinal products (Rev 1),chapter VI.C.4.1. Interim arrangements apply (see also Appendix 3 Modalities for reporting); NCAs in the EEA provide reports of suspected adverse reactions to the WHO (see also Appendix 4of GVP Module VI, Rev 1, Transmission of ICSRs to World Health Organization (WHO)).4.2. SUSAR reporting – clinical trialsPrior to the initiation of the EudraVigilance cutover period the following applies: Sponsors report suspected unexpected serious adverse reactions (SUSARs) for clinical trials inaccordance with the present arrangements and based on the Detailed guidance on the collection,verification and presentation of adverse event/reaction reports arising from clinical trials onmedicinal products for human use (‘CT-3’)(2011/C 172/01).4.3. Medical literature monitoring (MLM) by the AgencyPrior to the initiation of the EudraVigilance cutover period the following applies: EMA operates the medical literature monitoring (MLM) service in accordance with Article 27of Regulation (EC) No 726/2004.4.4. Data submission on medicines to the XEVMPD Prior to the initiation of the EudraVigilance cutover period the following applies: MAHs submit data on medicines using the XEVMPD and keep this information up-to-date inaccordance with Article 57 of Regulation (EC) No 726/2004.4.5. Signal management NCAs and EMAPrior to the initiation of the EudraVigilance cutover period the following applies: EMA and NCAs in the EEA perform signal management in accordance with (GVP) Module IX –Signal management.EudraVigilance Go-Live PlanEMA/399493/2017Page 9/70
4.6. EudraVigilance registration of organisation/usersPrior to the initiation of the EudraVigilance cutover period the following applies: The registration process of new organisations and users (new users and updates) continues inaccordance with the established registration process and the phased EVDAS registration scheduleas described at the EudraVigilance: how to register webpage.4.7. Interoperability testing with the new EudraVigilance XCOMP (test)environmentPrior to the initiation of the EudraVigilance cutover period, organisations which have electronicsubmissions of ICSRs to EudraVigilance established, should perform the gateway configuration andcommunication testing with XCOMP (refer to the EU ICSR Implementation Guide). Organisations that will continue to use established E2B(R2) systems should use the E2B(R3) testfiles available for download from the external compliance testing environment (XCOMP) and testthe upload of the files in their local pharmacovigilance/safety system with a backwards-andforwards conversion solution. Organisations should refer to the following documents in support of their testing activities: EudraVigilance technical support plan for national competent authorities in the EEA EudraVigilance checklist for national competent authorities in the EEA EudraVigilance testing instructions and checklist for marketing authorisation holders andsponsors of clinical trials in the EEA Organisations should only contact the Agency if they encounter difficulties with the testing.Organisations preparing for electronic transmissions of ICSRs to EudraVigilance for the first time orperforming major upgrades to established systems should consult the EudraVigilance: electronicreporting webpage. XCOMP will not be available for testing on 18, 19 and 20 September 2017; this applies to thegateway and EVWEB system components of the XCOMP environment. Any ICSR data submittedpreviously into the EudraVigilance XCOMP test environment will be deleted by EMA. XCOMP will not be available for testing during the week of 23 to 27 October 2017. The Gateway will not be available on 23 September 2017 due to software upgrades.4.8. Adrreports.eu portalPrior to the initiation of the EudraVigilance cutover period, the public can access information onsuspected adverse reactions related to medicines at the adrreports.eu portal. EMA will regularly updatethe data as per the current process.EudraVigilance Go-Live PlanEMA/399493/2017Page 10/70
4.9. EudraVigilance go-live rehearsal by EMAThe go-live rehearsal (mock cutover) is utilised by the EMA to practice and validate the technicalaspects of the internal go-live plan prior to the launch of the new EudraVigilance system on 22November 2017.It is a way of fine-tuning the process and of minimising the risks prior to full production cutover. EMAwill test the launch of the new system and ensure that controls are in place by applying milestones anddecision points that will drive a successful outcome of the rehearsal.EudraVigilance Go-Live PlanEMA/399493/2017Page 11/70
Chart 2: EudraVigilance pre-cutover period and key activities (Note: duration is indicated in calendar days)IDTask NameStartFinishDuration1EudraVigilance pre-cutover period26/06/201707/11/2017135d2ADR reporting - Interim arrangements26/06/201707/11/2017135d3SUSAR reporting for clinical trials bysponsors26/06/201707/11/2017135d4Medical literature monitoring by EMA26/06/201707/11/2017135d5Data submission on medicines (Art 57)26/06/201707/11/2017135d6Signal management by EMA and 09/201723/10/201733d78910EudraVigilance registration oforganisations and usersEV XCOMP interoperability testing bystakeholdersGateway software upgrade – plannedgateway downtimeEV XCOMP interoperability testing bystakeholders11EV XCOMP interoperability testing eu portal – data V Go-live rehearsal by EMA (1)21/07/201722/08/201733d14EV Go-live rehearsal by EMA (2)23/08/201708/09/201717d15EV Go-live rehearsal by EMA (3)18/09/201711/10/201724dEudraVigilance Go-Live PlanEMA/399493/2017Jul 201725/62/79/716/7Aug 201723/730/76/813/8Sep 201720/827/8Page 12/703/910/917/9Oct 201724/91/10Nov 20178/10 15/10 22/10 29/10 5/11 12/11 19/11
5. EudraVigilance cutover activitiesFor the successful cutover from the current to the new EudraVigilance system, integrated system andbusiness transition activities will need to be performed that subsequently will also impact stakeholders.In practice this implies that some of the current EudraVigilance system components will not beavailable for a defined period of time so that the new EudraVigilance system production environmentcomponents can be activated and the current legacy data of more than 11 million ICSRs can bemigrated.The business processes that are impacted by the cutover period and associated timelines arepresented in chart 3.IDTask NameStartFinishDuration1EudraVigilance cutover period08/11/201721/11/201710d2ADR reporting - alternative 789SUSAR reporting for clinical trials bysponsors -alternative arrangementsMedical literature monitoring by EMA –partial serviceData submission on medicines (Art 57) unavailableSignal management by EMA and NCAs –minor impactEudraVigilance registration oforganisations and users – not availableAdrreports.eu portal -data aggregation/publication – no impactEV XCOMP interoperability testing bystakeholders – no impactNov 20175/1112/1119/11Chart 3: Activities impacted by the cutover period and associated timelines (Note: duration isindicated in business days excluding weekends)The cut-over activities for the transition from the current to the new EudraVigilance system will starton the 8 November 2017 at 00:00 a.m. UK time and will end on 22 November 2017 at 9:00 a.m. UKtime.The EudraVigilance system components, their availability during the cutover, the impactedstakeholders and business processes are summarised in Table 1.EudraVigilance Go-Live PlanEMA/399493/2017Page 13/70
Table 1. Summary of EudraVigilance system components and impact of downtimeEudraVigilanceAvailability duringStakeholderBusiness processesSystem ially availableNCAs, MAHs,ADR reporting, SUSARsponsors, EMAreporting, data submission onGatewaymedicinesWEBTRADER: EVWEBUnavailableand EVPOSTNCAs, MAHs,Electronic submission ofsponsors, EMAICSRs (pre and postfunctionsauthorisation), electronicsubmission of on medicinesEVWEBUnavailableNCAs, MAHs,ADR reporting, SUSARsponsors, EMAreporting, MLM service ICSRgeneration, data submissionon medicinesEudraVigilanceUnavailablerestricted areaNCAs, MAHs,Access to information onsponsors, EMAOrganisation IDs; userprivilege updates; access toMLM service tracking sheetsEudraVigilanceUnavailableRegistrationNCAs, MAHs,Registration of organisationsponsors, EMAand usersNCAs, MAHs,Business rule validation, ICSRsponsors, EMAprocessing, baseManagement Systemduplicate management, ETL(EVDBMS)for EVDASEVDAS, eRMRsAvailableNCAs, EMASignal management (last datarefresh on 7 November 2017)Addreports.eu portalAvailablePublicAccess to ADRs by patientsand healthcare professionals(last data refresh based onpresent monthly schedule)An overview of the business processes that are supported/not supported based on the availability ofthe EudraVigilance system components during the cutover period as well as the alternativearrangements that should be followed by stakeholders are reflected in Table 2 and further described inchapters 5.1. to 5.7.EudraVigilance Go-Live PlanEMA/399493/2017Page 14/70
Table 2. Overview of the processes that are supported and not supported during the cutover period and alternative arrangements that should be rocess supported duringProcess NOT ing cutoverarrangements yavailablecutoverNCAs, MAHs,sponsors, EMAXML/business ruleSee reporting options assubmissions of ICSRsvalidation will not bedescribed in chapter 5.1(safety) and ACKsupportedand 5.2.Electronic ICSR messages:submissions Gateway organisationto gatewayorganisationMDNs will be generatedb.EudraVigilancePartialNCAs, MAHs,Gatewayavailablesponsors, EMA EVWEB andWEBTRADERorganisations, ACKs willmessages between:not be generated.Gateway organisationorganisationfunctions For submissions to(safety) and ACKto WEBTRADEREVPOSTICSR submissions of ICSRsWEBTRADER:submissionsElectronic MDNs will begenerated ACKs will only bereturned once the newEudraVigilanceproduction environmentgoes live andWEBTRADERorganisations havegenerated ACKEudraVigilance Go-Live PlanEMA/399493/2017Page 15/70Gatewayorganisations muststop the process of resubmitting safetymessages toWEBTRADERorganisations forwhich after 48 hoursno ACKs have beenreceived.See reporting options asdescribed in chapter 5.1
IDEudraVigilanceAvailabilityStakeholderProcess supported duringProcess NOT ing cutoverarrangements lanceGatewayNotavailableNCAs, MAHs,Not applicableNo electronic submissions sponsors, EMAof ICSRs (safety) and ACKmessages:ICSRsubmissions Gateway organisationto EudraVigilance(EVPM and EVCTM)and 5.2.The senderorganisation must submitvalid ICH E2B(R2) or ICHE2B(R3) safety messagesto EudraVigilance (EVPMor EVCTM as applicable)when the gateway of thenew EudraVigilancesystem is going live.See reporting options asdescribed in chapter 5.1and 5.2.d.WEBTRADER:EVWEB andEVPOSTfunctionsUnavailableNCAs, MAHs,sponsors, EMANoneNo electronic submissions of ICSRs (safety) and ACKmessages possible by: ICSRGateway organisation toEudraVigilance (EVPM andsubmissions valid ICH E2B(R2) or ICHE2B(R3) safety messagesto EudraVigilance (EVPMEVCTM)or EVCTM as applicable)WEBTRADERnew EudraVigilanceorganisations toEudraVigilance (EVPM andEVCTM)EudraVigilance Go-Live PlanEMA/399493/2017The senderorganisation must submitPage 16/70when the gateway of thesystem is going live.See reporting options asdescribed in chapter 5.1
IDEudraVigilanceAvailabilityStakeholderProcess supported duringProcess NOT ing cutoverarrangements duringcomponentdowntimecutoverand 5.2.e.WEBTRADER:UnavailableEVWEB andMAHs,NoneNo electronic sponsors, EMAEVPOSTfunctions)See reporting options assubmissions of data ondescribed in chapter 5.1medicines (Art 57) areand 5.2.possible. This applies to:Data on medicinesGateway organisation toXEVMPDsubmissions WEBTRADER organisationto XEVMPDf.EudraVigilanceUnavailableRestricted AreaNCAs, MAHs,None Access to informationsponsors ofprovided in the restrictedclinical trials,area of EudraVigilance i.e.EMAOrganisation Identifiers inNonesupport of the EDI process;MLM tracking sheetsg.EVWEB(incl. MLM ICSRUnavailableNCAs, MAHs,None sponsors, EMANo electronic submissionsof ICSRs (safety) and ACKmessages.Export Manager) No receipt of safety andacknowledgement messagespossible EudraVigilance Go-Live PlanEMA/399493/2017Accessing and downloadPage 17/70The senderorganisation must submitvalid ICH E2B(R2) or ICHE2B(R3) safety messagesto EudraVigilance (EVPMor EVCTM as applicable)when the gateway of thenew EudraVigilance is
IDEudraVigilanceAvailabilityStakeho
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)
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.
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
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:
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
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
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.
security rules for protecting EU classified information, certain provisions in this guide are still based on Commission Decision 2001/844. In the absence of new guidelines they should continue to be applied. Under the new security rules, all classification markings must now be written in FR/EN format (e.g. RESTREINT UE/EU RESTRICTED). EU grants: H2020 Guidance — Guidelines for the .
