EudraVigilance Information Days provide a forum to update stakeholders about the achievements and latest developments with regard to EudraVigilance in the broader context of implementation of the pharmacovigilance legislation.
A dedicated session on EudraVigilance will provide a summary of the EudraVigilance functionalities, which are, according to Article 24 of Regulation 726/2004, subject to an independent audit. A progress update on the preparation for literature monitoring services by the Agency as well as on the finalisation of the EU ICSR Implementation Guide will be also provided.
This Information Day will also provide an insight into the three year EU-wide pharmacovigilance project coordinated by MHRA and referenced as “Strengthening Collaboration for Operating Pharmacovigilance in Europe” (SCOPE). This Joint Action aims to further strengthen pharmacovigilance with main focus on operation at Member States level.
Other topics addressed will include the communication and follow up of safety signals, frequently raised implementation questions related to GVP module VI and commonly encountered data quality issues in relation to ICSR reporting.
Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE)
EudraVigilance functionalities to be audited
Monitoring of medical literature by the Agency and the entry of relevant information into EudraVigilance
EudraVigilance data quality
Experience following publication of PRAC recommendations based on safety signals
GVP Module VI – questions and answers session
Notification process on withdrawn products
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52
Hotel & Travel
Attendees have to make their own reservation. Recommended hotel close to the EMA:
Hilton London Docklands Riverside
265 Rotherhithe Street,
London , SE16 5HW,
Telephone: +44 (0)20 7231 1001
Fax: +44 (0)20 7231 0599
Special negotiated rate for participants to the EudraVigilance Information Day for a limited number of rooms is GBP 139.00 per room incl. breakfast and VAT. Please book your room at least 30 days before arrival through this online link:
The hotel is situated opposite of Canary Wharf conveniently connected by a shuttle boat. The landing stage is in walking distance to the EMA (2 min).
The Information Day takes place at the
European Medicines Agency (EMA)
7 Westferry Circus
London E14 4HB
Web site: www.ema.europa.eu
Please click here for a map on how to find the EMA.
Please click here for some useful transport information.
For the special security access procedure to enter the EMA building, please calculate a delay of up to 10-15 minutes. It is not possible to enter the building before 8.00 am.