Electronic Reporting of ICSRs in the EEA
Dec 12 2012 9:00AM - Dec 14 2012 4:00PM | INFARMED
Parque de Saúde de Lisboa
Avenida do Brasil, 53
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:
- Qualified persons for pharmacovigilance
- Pharmacovigilance experts
- Data entry professionals
- Medical coding professionals
- Persons interested in building or updating their knowledge in electronic adverse reaction reporting
Participants who complete this course should be able to:
- Apply ICH rules to safety reporting
- Describe the registration process with EudraVigilance
- Understand the Concepts of Electronic Transmission of ICSRs
- Describe the EudraVigilance Gateway
- Describe the Web Trader functions
- Explain the reporting processes for fully automated organizations, post-function users, and EVWEB users
- Create, validate, and send safety messages
- Create, validate, and send:
- Follow-up reports
- Nullification reports
- Literature reports
- Parent-child reports
- Study reports
- Reports with medical and drug history
- Apply EudraVigilance business rules
- Create and send acknowledgments of received ICSR messages
- Query, view, browse, and download safety reports
- Query, view, and browse MedDRA through the EVWEB
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
Hotel & Travel
A special discount for SMEs is available. To proof your status as an SME, a confirmation of the European Medicines Agency is necessary.
CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:
- Industry (Member/Non-member) = €200.00
- Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
- Tutorial cancellation: €50.00
If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.