The Amgen Global Safety (AGS) Department contributes to clinical development and commercial operations in ensuring regulatory compliance. Similar to other Development functions, it has an integrated International presence, with staff placed in the UK and most of Amgen's local Country Offices across Europe.

For products under development, we contribute to protocol design (defining the safety data to be collected), evaluate safety data, prepare regulatory reports (for serious adverse reactions) and contribute to the safety sections of investigator brochures during Phases 1-3. We also make a significant contribution to annual reports and product license applications.

Operationally driven, once a product has been marketed we analyse and report on spontaneous events, maintain data sheets and review and distribute Periodic Safety Update Reports (PSURs). We have an input into Phase 4 study design, and appraising and summarising concomitant safety data. Furthermore, we compile information in order to reply to regulatory safety questions and maintain awareness of competitor product safety profiles. In addition, we collaborate with the US headquarters team, ensuring a strong International input into the development and implementation of safety plans.