Periodic safety update report information day

• Dată:
  Vineri, 28 octombrie 2016, Toată ziua
• Locația:
  European Medicines Agency, Amsterdam, the Netherlands

This information day provides a forum to discuss ongoing activities and status of periodic safety update report (PSUR) single assessment procedures, with a particular emphasis on the PSUR roadmap and how it supports reaching a common understanding of the single assessment. The roadmap is key to optimising the process and content of PSURs and the EU single assessment (PSUSA). The information day will also look into the procedural improvements that are already implemented and discuss further improvements based on views from the pharmaceutical industry. The event will also provide an opportunity for industry, EMA and national competent authorities to share experiences on the mandatory use of the PSUR repository lessons learned from the transition. It will also outline the role of PSURs in inspections from inspectors' and industry's point of view.

Documents

Agenda - Periodic safety update report information day

Presentation - Pharmacovigilance through the Product Lifecycle and the Central Role of the PSUR (June Raine)

Presentation - Pharmacovigilance through the Product Lifecycle and the Central Role of the PSUR (Michael Richardson)

Presentation - PSUR roadmap - Achieving a common understanding of the PSUR single assessment in Europe (Irene Rager)

Presentation - What is an ideal PSUR? – A new focus based on aligned expectations (Margarida Guimarà£es)

Presentation - The refocussed PSUR and a new approach to assessment (Menno van der Elst)

Presentation - How Industry can improve PSURs and achieve alignment of expectations (Dave Lewis)

Presentation - Delivering the benefits of the new PSUR for healthcare professionals and patients – efficient and effective implementation An Industry perspective (Klaudija Marijanovic Barac)

Presentation - Delivering the benefits of the new PSUR for healthcare professionals and patients – efficient and effective implementation –A Regulator’s perspective (Kora Doorduyn-van der Stoep)

Presentation - Making best use of the PSUR Repository (Ana Zanoletty)

Presentation - Making best use of the PSUR Repository (Jean Louis Hottart)

Presentation - Optimising the use of the EURD list – the key to the single assessment (Menno van der Elst)

Presentation - Optimising the use of the EURD list – the key to the single assessment: Procedural aspects (Robin Ruepp)

Presentation - The role of PSURS in pharmacovigilance inspections - Getting it right and practical experience (Ernesto Vera Sà¡nchez)

Presentation - The role of PSURs in pharmacovigilance inspections –Getting it right and practical experience (Sue Rees)