Need for this EudraVigilance Information Day
EudraVigilance Information Days provide a forum to update stakeholders about the achievements and latest developments with regard to the implementation of the new pharmacovigilance legislation. It will provide important technical and operational details that need to be taken into account by marketing authorisation holders in their daily application of the new legislation in the broader context of EudraVigilance and adverse reaction reporting in the EU.
This EudraVigilance Information Day will highlight the latest developments in applying data privacy legislation and the impact on adverse drug reaction data exchange between stakeholders. A dedicated questions and answers session will focus on expected updates of the Good Pharmacovigilance Practice (GVP) Module VI, relating to the management and reporting of adverse reactions to medicinal products. Other topics will include highlights of the work of the new Pharmacovigilance and Risk Assessment Committee (PRAC), including experience on signal management related to electronic reaction monitoring reports (eRMRs) and based on EudraVigilance data, practical experience with the new Pharmacovigilance System Master File (PSMF) and updates on the Risk Management Plan, including the latest information on Post-Authorisation Safety Studies (PASS) and Post-Authorisation Efficacy Studies (PAES).
A look at the pharmacovigilance activities of the Croatian Medicines Agency (HALMED) in preparation for EU accession on 1 July 2013 will conclude this Information Day.
Who Should Attend
This programme will benefit Qualified Persons Responsible for Pharmacovigilance (QPPVs) and individuals involved in:
Latest developments on applying data privacy legislation and its impact on the adverse drug reaction data exchange between stakeholders
Update of GVP Module VI – detailed questions and answers session
Medicinal products subject to additional monitoring
The work of the PRAC
Experience of signal management based on EudraVigilance data
Implementation experience with the new PSMF
Risk Management Planning including the latest information on PASS and PAES
EU accession of Croatia
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
London, E14 9SJ,
Telephone: +44 (0)871 222 0042
Fax: +44 (0) 871 222 7712