Work Package 7 efforts in the last few months have been focused on preparing five- one day long site visits of National Competent Authorities (NCAs) in order gather information about their pharmacovigilance and quality management systems. Visits to Czech Republic, Ireland, Lithuania, the Netherlands, and Spain took place in May and June 2014. The purpose of the site visits was to collect information through informal discussion with NCAs about their experience, achievements and challenges in operating pharmacovigilance systems – for the benefit of the project and for the improvement of national pharmacovigilance systems across the EU. Discussions during the site visits focused on identifying best practice examples, and how Member States have been interpreting the legislation and guidance. The knowledge gained during the visits proved to be very valuable to understand how quality management practices are run by NCAs within their resources and facilities whilst maximising benefits for public health.
