Description
Periodic Safety Update Reports (PSURs) are a regulatory requirement in US, Europe and Japan and now other countries are beginning to request safety updates to support new submissions and renewals of marketed products. Individual requests for PSURs are a potential burden on pharmacovigilance resources. This workshop will focus on the practicalities of meeting the regulatory, scientific and public health expectations associated with the PSUR process, including EU Harmonisation of PSURs. The speakers will cover the topic from both regulatory and pharmaceutical industry perspectives and a practical session will give participants hands-on experience in dealing with some of the potential issues in producing PSURs
