EudraVigilance is the European data-processing network and management system, established at the European Medicines Agency (EMA) to support the electronic exchange, management, and scientific evaluation of Individual Case Safety Reports (ICSRs) related to all medicinal products authorized in the European Economic Area (EEA). EudraVigilance also incorporates signal detection and data analysis facilities and is therefore regarded as one of the main pillars of the European Risk Management Strategy, which aims to strengthen the conduct of pharmacovigilance in the EEA.
Community legislation is in place to ensure that all stakeholders, including National Competent Authorities (NCAs), marketing authorisation holders (MAHs) and sponsors of clinical trials in the EEA collect, collate and exchange adverse drug reactions.
The electronic transmission of ICSRs, based on the results of the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) remains a priority in the area of pharmacovigilance to make the adverse reaction data exchange and management more efficient. EVWEB is an Internet-based reporting tool developed by the European Medicines Agency to allow Small and Medium Size Enterprises (SMEs) that hold marketing authorisations in the EEA and sponsors of clinical trials, to report electronically adverse reactions, in full compliance with the internationally agreed standards to the European Medicines Agency and NCAs.
The EudraVigilance Training Programme has been designed for:
Organisations e.g. SMEs, (non-) commercial sponsors that intend to use EVWEB to implement electronic transmission of safety data. Organisations intending to use EVWEB are required to follow a training course to ensure the correct use of the reporting tool. They can apply for more than one person to be trained, or alternatively, send one person who will subsequently train other users internally in the organisation.
Pharmaceutical companies that perform electronic transmission of ICSRs and use their locally established ICH compliant data-processing network (Gateway) and management system, may wish to attend this course to learn how to access and query the ICSRs that they have submitted to EudraVigilance.
National Competent Authorities that wish to acquire knowledge about the functionalities of the tool, specifically in relation to data retrieval and evaluation to facilitate the scientific use of the data contained in the database
Who Should Attend
The course is intended for people in charge of pharmacovigilance and drug safety in MAHs and National Competent Authorities with legal reporting obligations in the EEA.
The target audience of this training course also includes, but is not limited to:
Participants who complete this course should be able to:
- Fundamentals of the electronic reporting of ICSRs
- ICH M2 safety and acknowledgment message specifications
ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices as well as the current EudraVigilance Business Rules
- How to navigate the EudraVigilance system
How to enter information into the EudraVigilance system including mandatory fields
Training on the Web Trader for transmission of documents on the EudraVigilance Gateway
Instruction on using EVWEB to browse MedDRA
DIA Europe, Middle East and Africa
Phone: +41 61 225 51 51
Fax: +41 61 225 51 52
Monday-Friday 8:00-17:00 CET
For technical questions or registration to EudraVigilance:
EudraVigilance helpdesk for Sponsors
Eudravigilance registration team
Hotel & Travel
Please contact Ms. Madalina Nedelciu from Business Travel to book a hotel room, flight or airport transfer. She will be pleased to assist you.
S.C. BUSINESS TRAVEL TURISM S.R.L.
Aleea Alexandru nr. 9A, 1st Distict,
Tel. +4 021 2315619
Fax. +4 021 2315622
Mob.+4 0729 835 337
It is not possible to register online for this course. Please fill in the registration form at the back of the programme (view pdf).
A special discount for SMEs on the standard rate is available. It is not possible to receive this discount when booking online. To proof your status as SME, a confirmation of the European Medicines Agency is necessary.
Please contact the DIA office(email@example.com) for more information.