Introduction To Training Offering By EMA - European Medicines Agency

Introduction to training offering byEMATraining Module PhV-M0This module provides an overview of all training offerings planned by EMA in thearea of EudraVigilance, EVDAS, ADR reporting and signal detection providinglearning paths for new and existing usersAn agency of the European Union

Overview of Module PhV-M0Introduction to this training moduleOverview of the training approachLearning pathway by stakeholder groupWhen should I undertake training?Where can I access the training materials?1PhV-M0 Introduction to training offering by the EMA

Introduction to this training moduleOverview of the training approachLearning pathway by stakeholder groupWhen should I undertake training?Where can I access the training materials?2PhV-M0 Introduction to training offering by the EMA

Introduction: AudienceTarget audience for this training module: National Competent Authorities (NCAs) in the European Economic Area (EEA) Marketing authorisation holders (MAHs) Sponsors of Clinical Trials3PhV-M0 Introduction to training offering by the EMA

Introduction: Learning ObjectivesAt the end of module PhV-M0 you should be able to: Understand the training offerings by the EMA in the area of EudraVigilance,EVDAS, ADR reporting, signal detection Apprehend which training modules are relevant from the perspective of anNCA, MAH, Sponsor of clinical trial Understand where to access the training materials4PhV-M0 Introduction to training offering by the EMA

Introduction to this training moduleOverview of the training approachLearning pathway by stakeholder groupWhen should I undertake training?Where can I access the training materials?5PhV-M0 Introduction to training offering by the EMA

Training curriculum areas (1 of 2)Training is organised by subject matter around three rationsIT SystemsOperations6Modules detailing the key changes in pharmacovigilance legislation, standards andguidelines and the impact of these on pharmacovigilance activitiesModules describing the EudraVigilance and EVDAS functionalities and components, as wellas the various data analysis, submission, visualisation and reporting optionsModules providing instructions on the modifications required to prepare internal systems forthe EudraVigilance system enhancementsPhV-M0 Introduction to training offering by the EMA

Training curriculum areas (2 of 2)Training areas are organised against the following learning needs:IT uctionto trainingEVAccessPolicyITdevelopmentNew PhVlegislationGVPmodulesHow to registerDatasubmissionEV M0 Introduction to training offering by the mationDataexportEudraVigilancesystemEudraVigilance DataAnalysis system

Training delivery methodsSupport through guidancedocumentationDetailed guidance documentation and usermanuals will be produced to explain thefunctionality of each component of the EVsystem detailing step by step how thesystem should be used.Support through E-LearningTraining is predominately delivered throughnarrated information videos hosted on the EMAcorporate website. Optional quizzes are provided for all Elearning modules to enhance userunderstanding.E-learningGuidanceFor new users, a mandatory competencyassessment will have to be undertaken uponcompletion of the training coursesIn addition, ‘contextual help’ information willbe available online in the new EVWEBinterface.Support through webinarsSupport through face to faceFace to face training will havelimited availability and will bemainly targeted at new users8PhV-M0 Introduction to training offering by the EMAFace to faceWebinarsA series of webinars will be organised overthe course of 2017 targeted at NCAs andMAHs. Participants will be reminded 4days in advance to provide questions (thiswill help us to start the webinar session)and they will have the opportunity to askquestions during the webinars.

Training module tsE-learningModules9PhV-M0 Introduction to training offering by the EMAFeedback on E-learning modules and theirattendant user manuals can be submitted viathe survey link found on all training materials.QuizzesOptional multiple choice quizzes are providedfor most E-learning modules to enhancecontent understanding. These can be accessedvia the EudraVigilance training page.Competency AssessmentA mandatory competency assessment will beundertaken by new users. One user per organisation will undertakethe assessment, who should share acquiredknowledge to relevant colleagues withintheir organisation. The assessment will consist of a multiplechoice test and assessed simulation ofsubmitting an ICSR.

Introduction to this training moduleOverview of the training approachLearning pathway by stakeholder groupWhen should I undertake training?Where can I access the training materials?10PhV-M0 Introduction to training offering by the EMA

NCA Learning PathwayPharmacovigilance OperationsEudraVigilance OperationsIT Systems OperationsNew EV functionalities and 2010pharmacovigilance legislationHow to register with EudraVigilance andEVDASISO ICSR standard implementation forIT system developersImplementing ISO ICSR/ICH E2B R3Introduction to EV system componentsand system functionalitiesInstructions on how to test ICSRsubmissions to EVHow to prepare for simplified adversereaction reporting in the EURevised EV Access policy – impact onstakeholdersRevised GVP guidelines – updates andimpactMethodological guidance for SignalDetectionRevised GVP Module VIRevised GVP Module XIPharmacovigilance Operations supportwebinar11PhV-M0 Introduction to training offering by the EMAReporting of ICSRs for EV usersEudraVigilance export manager andICSR downloadEVDAS training for NCAsEVDAS Report ManualEVWEB User ManualPatients ADR WebsiteEV/EVDAS Functionalities webinarEV training on electronic reporting ofICSRs in the EEA (new users)Recommended learningSupporting learning

MAH Learning PathwayPharmacovigilance OperationsEudraVigilance OperationsIT Systems OperationsNew EV functionalities and 2010pharmacovigilance legislationHow to register with EudraVigilance andEVDASISO ICSR standard implementation forIT system developersImplementing ISO ICSR/ICH E2B R3Introduction to EV system componentsand system functionalitiesInstructions on how to test ICSRsubmissions to EVHow to prepare for simplified adversereaction reporting in the EUReporting of ICSRs for EV usersRevised EV Access policy – impact onstakeholdersRevised GVP guidelines – updates andimpactMethodological guidance for SignalDetectionRevised GVP Module VIRevised GVP Module XIPharmacovigilance Operations supportwebinarEudraVigilance export manager andICSR downloadEVDAS training for MAHsMedical Literature monitoring serviceEVWEB User ManualMAH Level 1 Access to EVDASEVDAS Report ManualPatients ADR WebsiteEV/EVDAS Functionalities webinar12PhV-M0 Introduction to training offering by the EMAEV training on electronic reporting ofICSRs in the EEA (new users)Recommended learningSupporting learning

Sponsors of Clinical Trials Learning PathwayPharmacovigilance OperationsEudraVigilance OperationsIT Systems OperationsNew EV functionalities and 2010pharmacovigilance legislationHow to register with EudraVigilance andEVDASISO ICSR standard implementation forIT system developersImplementing ISO ICSR/ICH E2B R3Introduction to EV system componentsand system functionalitiesInstructions on how to test ICSRsubmissions to EVHow to prepare for simplified adversereaction reporting in the EUReporting of ICSRs for EV usersRevised EV Access policy – impact onstakeholdersEVWEB User ManualMethodological guidance for SignalDetectionEudraVigilance export manager andICSR downloadRevised GVP Module XIPatients ADR WebsiteEV training on electronic reporting ofICSRs in the EEA (new users)Recommended learning13PhV-M0 Introduction to training offering by the EMASupporting learning

Introduction to this training moduleOverview of the training approachLearning pathway by stakeholder groupWhen should I undertake training?Where can I access the training materials?14PhV-M0 Introduction to training offering by the EMA

Stakeholder training planningStakeholders are advised to start training well in advance of the new system beingimplemented with regular, refresher training ahead of the move to simplified reporting.Training Availability datesQ1 2016Q2 2016Q3 2016Training planpublicationQ4 2016Q1 2017Q2 2017Announcement training datesQ3 2017Q4 2017Support webinarsStakeholders can start preparing their own training plansMove to EMAsimplified reportingRelease of training materialsStakeholders can start to undertake training15PhV-M0 Introduction to training offering by the EMA

Introduction to this training moduleOverview of the training approachLearning pathway by stakeholder groupWhen should I undertake training?Where can I access the training materials?16PhV-M0 Introduction to training offering by the EMA

EudraVigilance Training PageAll training modules can be accessed via the EudraVigilance Training Page.EMA Website - Human Regulatory - Pharmacovigilance - EudraVigilance - Training pageThe e-learning modules are listed as clickable links in the table at the top of the webpagein a navigable table.Modules will generally contain A summary of learningobjectives Target audience E-learning video link Downloadable e-learningslides Supporting materialsrelevant to the module Quiz linkFor NCAs only, the training modules will also be available on the EU Network training centre: http://euntc.eudra.org17PhV-M0 Introduction to training offering by the EMA

Summary of PhV-M0We are now at the end of the training module PhV-M0, which provided you to basis for: Understanding the training offerings by the EMA in the area of EudraVigilance, EVDAS,ADR reporting, signal detection Apprehending which training modules are relevant from the perspective of an NCA,MAH, Sponsor of clinical trial Understanding where to access the training materials and when to start training18PhV-M0 Introduction to training offering by the EMA

Feedback Please provide us with feedback on this E-learning module and any attendantguidance documents you have viewed by taking the EMA training survey. The survey is accessible via this link.19PhV-M0 Introduction to training offering by the EMA

Acronyms ilance Clinical Trials ModuleEVDASEudraVigilance Data Analysis SystemEVWEBEudraVigilance Web ApplicationGVPGuideline on good pharmacovigilance practicesICHInternational Council for Harmonisation of TechnicalRequirements for Pharmaceuticals for Human UseICSRIndividual Case Safety Report20PhV-M0 Introduction to training offering by the EMA

Acronyms (2)AcronymDescriptionMAHMarketing authorisation holderNCANational competent authorityPhVPharmacovigilance21PhV-M0 Introduction to training offering by the EMA

Thank you for your attentionFurther ean Medicines Agency30 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/contactFollow us on@EMA News

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