We are pleased to announce that thanks to the effort and commitment of the colleagues working in the SCOPE Work Package 8, WP8 – Lifecycle Pharmacovigilance Surveys were launched on 4 July 2014.
The surveys have been distributed to all SCOPE Partners using an online survey tool for completion by institutions at the national level (i.e. National Competent Authority, NCA).
The surveys focus on competency framework to support exemplary pharmacovigilance throughout the product lifecycle and explore existing standards for pharmacovigilance assessments in order to provide advice on: risk management plans; post authorisation safety studies (PASS), periodic safety update reports (PSURs) and referral procedures. It also examines the availability and use of alternative (epidemiological) data sources for assessment of these procedures in different European NCA settings. The results of the survey will be used to develop report, recommendations and assessors trainings on good assessment practice for NCAs in Europe.
The Italian Medicines Agency (AIFA) is the leader of WP8 and the individual surveys have been prepared by topic leaders:
Topic 1 Identification of available data sources outside spontaneous reporting – AIFA (Italy)
Topic 2 Risk Management Plan assessments – NOMA (Norway)
Topic 3 PASS protocols and study reports – MPA (Sweden)
Topic 4 Benefit/risk assessment in the context of PSUR and referral procedures – AIFA (Italy)
Topic 5 Competency – AIFA (Italy)
The other partners involved in realization of the WP8 survey are:
AEMPS (Spain)
EOF (Greece)
HPRA (Ireland)
MEB (Netherlands)
MHRA (United Kingdom)
INFARMED (Portugal)
The deadline for submitting completed questionnaires is 30 September 2014.
