Introduction to training offering by EMA Training Module PhV-M0 - PowerPoint PPT Presentation

Introduction to training offering by EMA Training Module PhV-M0 This module provides an overview of all training offerings planned by EMA in the area of EudraVigilance, EVDAS, ADR reporting and signal detection providing learning paths for new and existing users An agency of the European Union

Overview of Module PhV-M0 Introduction to this training module Overview of the training approach Learning pathway by stakeholder group When should I undertake training? Where can I access the training materials? 1 PhV-M0 Introduction to training offering by the EMA

Introduction to this training module Introduction to this training module Overview of the training approach Overview of the training approach Learning pathway by stakeholder group Learning pathway by stakeholder group When should I undertake training? When should I undertake training? Where can I access the training materials? Where can I access the training materials? 2 PhV-M0 Introduction to training offering by the EMA

Introduction: Audience Target audience for this training module: − National Competent Authorities (NCAs) in the European Economic Area (EEA) − Marketing authorisation holders (MAHs) − Sponsors of Clinical Trials PhV-M0 Introduction to training offering by the EMA 3

Introduction: Learning Objectives At 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 an NCA, MAH, Sponsor of clinical trial − Understand where to access the training materials PhV-M0 Introduction to training offering by the EMA 4

Introduction to this training module Introduction to this training module Overview of the training approach Overview of the training approach Learning pathway by stakeholder group Learning pathway by stakeholder group When should I undertake training? When should I undertake training? Where can I access the training materials? Where can I access the training materials? 5 PhV-M0 Introduction to training offering by the EMA

Training curriculum areas (1 of 2) Training is organised by subject matter around three areas: Modules detailing the key changes in pharmacovigilance legislation, standards and Pharmacovigilance guidelines and the impact of these on pharmacovigilance activities Operations Modules describing the EudraVigilance and EVDAS functionalities and components, as well EudraVigilance as the various data analysis, submission, visualisation and reporting options Operations Modules providing instructions on the modifications required to prepare internal systems for IT Systems the EudraVigilance system enhancements Operations 6 PhV-M0 Introduction to training offering by the EMA

Training curriculum areas (2 of 2) Training areas are organised against the following learning needs: IT Systems Pharmacovigilance Operations Operations IT Introduction New PhV development to training legislation ICSR EudraVigilance testing Operations EV GVP Access modules Policy EV system How to register General components information Data Data Data submission visualisation EudraVigilance export system Data analysis EudraVigilance Data 7 PhV-M0 Introduction to training offering by the EMA Analysis system

Training delivery methods Support through guidance documentation Detailed guidance documentation and user Support through E-Learning manuals will be produced to explain the Training is predominately delivered through functionality of each component of the EV narrated information videos hosted on the EMA system detailing step by step how the corporate website. system should be used. Optional quizzes are provided for all E- • E-learning learning modules to enhance user In addition, ‘contextual help’ information will understanding. be available online in the new EVWEB Guidance interface. For new users, a mandatory competency • assessment will have to be undertaken upon completion of the training courses Support through webinars A series of webinars will be organised over the course of 2017 targeted at NCAs and Webinars Support through face to face Face to face MAHs. Participants will be reminded 4 Face to face training will have days in advance to provide questions (this limited availability and will be will help us to start the webinar session) mainly targeted at new users and they will have the opportunity to ask questions during the webinars. 8 PhV-M0 Introduction to training offering by the EMA

Training module evaluation Surveys Feedback on E-learning modules and their attendant user manuals can be submitted via Surveys Quizzes the survey link found on all training materials. Quizzes Optional multiple choice quizzes are provided for most E-learning modules to enhance content understanding. These can be accessed via the EudraVigilance training page. Competency Assessments Competency Assessment E-learning A mandatory competency assessment will be Modules undertaken by new users. One user per organisation will undertake • the assessment, who should share acquired knowledge to relevant colleagues within their organisation. The assessment will consist of a multiple • choice test and assessed simulation of submitting an ICSR. 9 PhV-M0 Introduction to training offering by the EMA

Introduction to this training module Introduction to this training module Overview of the training approach Overview of the training approach Learning pathway by stakeholder group Learning pathway by stakeholder group When should I undertake training? When should I undertake training? Where can I access the training materials? Where can I access the training materials? 10 PhV-M0 Introduction to training offering by the EMA

NCA Learning Pathway Pharmacovigilance Operations EudraVigilance Operations IT Systems Operations How to register with EudraVigilance and New EV functionalities and 2010 ISO ICSR standard implementation for pharmacovigilance legislation IT system developers EVDAS Instructions on how to test ICSR Introduction to EV system components Implementing ISO ICSR/ICH E2B R3 and system functionalities submissions to EV How to prepare for simplified adverse reaction reporting in the EU Reporting of ICSRs for EV users Revised EV Access policy – impact on EudraVigilance export manager and stakeholders ICSR download Revised GVP guidelines – updates and EVDAS training for NCAs impact Methodological guidance for Signal EVDAS Report Manual Detection EVWEB User Manual Revised GVP Module VI Patients ADR Website Revised GVP Module XI EV/EVDAS Functionalities webinar Pharmacovigilance Operations support webinar EV training on electronic reporting of Recommended learning ICSRs in the EEA (new users) 11 PhV-M0 Introduction to training offering by the EMA Supporting learning

MAH Learning Pathway Pharmacovigilance Operations EudraVigilance Operations IT Systems Operations How to register with EudraVigilance and New EV functionalities and 2010 ISO ICSR standard implementation for pharmacovigilance legislation IT system developers EVDAS Introduction to EV system components Instructions on how to test ICSR Implementing ISO ICSR/ICH E2B R3 and system functionalities submissions to EV How to prepare for simplified adverse Reporting of ICSRs for EV users reaction reporting in the EU EudraVigilance export manager and Revised EV Access policy – impact on ICSR download stakeholders EVDAS training for MAHs Revised GVP guidelines – updates and impact Medical Literature monitoring service Methodological guidance for Signal EVWEB User Manual Detection MAH Level 1 Access to EVDAS Revised GVP Module VI EVDAS Report Manual Revised GVP Module XI Patients ADR Website Pharmacovigilance Operations support webinar EV/EVDAS Functionalities webinar Recommended learning EV training on electronic reporting of Supporting learning ICSRs in the EEA (new users) 12 PhV-M0 Introduction to training offering by the EMA

Sponsors of Clinical Trials Learning Pathway Pharmacovigilance Operations EudraVigilance Operations IT Systems Operations How to register with EudraVigilance and New EV functionalities and 2010 ISO ICSR standard implementation for pharmacovigilance legislation IT system developers EVDAS Instructions on how to test ICSR Introduction to EV system components Implementing ISO ICSR/ICH E2B R3 and system functionalities submissions to EV How to prepare for simplified adverse reaction reporting in the EU Reporting of ICSRs for EV users Revised EV Access policy – impact on EVWEB User Manual stakeholders Methodological guidance for Signal EudraVigilance export manager and Detection ICSR download Revised GVP Module XI Patients ADR Website EV training on electronic reporting of ICSRs in the EEA (new users) Recommended learning 13 PhV-M0 Introduction to training offering by the EMA Supporting learning

Introduction to this training module Introduction to this training module Overview of the training approach Overview of the training approach Learning pathway by stakeholder group Learning pathway by stakeholder group When should I undertake training? When should I undertake training? Where can I access the training materials? Where can I access the training materials? 14 PhV-M0 Introduction to training offering by the EMA