About
This course introduces the Periodic Safety Update Report (PSUR) and the related requirements, structure, content, and activities. Through selected exercises and a role play, relevant aspects of the PSUR preparation will be explored and discussed in view of the pharmacovigilance quality system and inspections. Besides sharing experience about pitfalls and challenges, the lecturers will discuss what is in the focus of Health Authorities’ assessment. Key differences between PSURs and RMPs will be presented with a focus on the impact of RMP updates on PSURs.