eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) - PowerPoint PPT Presentation

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning Session 1.2: Registration with EudraVigilance Version 5.4 An agency of the European Union

EudraVigilance registration Before the electronic submission of XEVPRMs can be initiated, MAHs need to register with EudraVigilance. From 26 July 2018 the registration process is updated to reflect the new user registration and account management processes following the integration of EV (human) with EMA's Account Management portal and Organisation Management Service (OMS). • Organisations are required to register electronically via the Organisations Management System (OMS); • User management takes place via the EMA Account Management Platform. 1 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning

Who can register with EudraVigilance • Registered organisations can be: – pharmaceutical companies (marketing-authorisation holders, applicants), their affiliates and users, – commercial and non-commercial sponsors, their research departments and their users. 2 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning

EudraVigilance registration: new organisations New organisation must register: • in OMS for XEVMPD production environm ent ; • using the existing EV registration form for XCOMP (for EV Post functionality); the first user must self-register in the EMA Account Management Platform and • submit an EMA Service Desk portal request for his/ her role (e.g. QPPV/ RP) to be certified by the EMA; • the QPPV/ RP will then be able to approve access to new users and remove existing users. 3 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning

EudraVigilance registration: already registered organisations MAH organisations already registered with EudraVigilance without access to the XEVMPD should request an update of their EudraVigilance profile in order to successfully submit XEVPRMs by submitting a request via the EMA Service Desk portal: • The QPPV or his/ her deputy/ RP shall request for their organisation to be added to the XEVMPD community for the external compliance (XCOMP) testing environment and/ or the production environment. • The Organisation ID shall be specified in this request. 4 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning

Registration of third party service providers • Third party service providers (e.g. CROs) cannot register by themselves, they need to be registered on behalf of the MAH/ applicant/ commercial or non-commercial sponsor organisation as a virtual affiliate. • CRO users will need to request a ‘contributor’ role via the EMA Account Management Platform for the specific organisation. – If users work for multiple organisations, they will need to request a ‘contributor’ role for each of those organisations separately. 5 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning

Registration in EudraVigilance • In order to register as a user or to create a new organization, users need to first have an EMA Account. For new users, please register at the EMA Account Management Platform. • The EudraVigilance Registration page provides a summary of the registration process as well as a library of the required documents you will need in your registration and access management. 6 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning

Registration in EudraVigilance: Registration Manual The EudraVigilance team has created a step by step EMA EudraVigilance Registration Manual available at the EudraVigilance: How to register webpage for all the different processes of the registration: • create an EMA Account; • request and management of roles; • access management; • creation and management of an organization and Affiliates • creation and management of Virtual Affiliates (for CRO organizations and users). 7 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning

Further Information and Contacts • All documents related to electronic submission of information on medicines as per Article 57(2) requirements are available at the Guidance documents webpage. • Description of the EV registration process is available at the EudraVigilance: How to register webpage . • EV Registration related questions as well as technical questions or questions related to the submission of investigational medicinal products (IMPs) or authorised medicinal products (AMPs) should be submitted via the EMA Service Desk portal (https: / / servicedesk.ema.europa.eu). 8 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning