14-15 September 2009 in Uppsala, Sweden.
Informal meeting of the Pharmacovigilance Working Party (PhVWP) that involves the participation of national experts and representatives from competent authorities from European Economic Area-EEA countries (EU Member States, Iceland, Liechtenstein and Norway).
The mission of the PhVWP is to make recommendations to the EMEA Committee for Medicinal Products for human use (CHMP) and to the National Competent Authorities (Heads of Medicines Agencies, HMA) on all issues directly or indirectly related to the safety of medicines and the assessment of adverse drug reactions and to enable effective identification and suggest risk management measures at any phase in the product life cycle.
The Informal PhVWP meeting will focus on the following areas;
- The proposal from the European Commission for amending the pharmaceutical legislation on pharmacovigilance
- Risk communication/pharmacovigilance transparency
- Risk management
- Pharmacovigilance Inspections
- PSUR worksharing