Senior Regulatory Affairs Manager
Catherine Akers has worked at Amgen for more than 10 years working in Regulatory Affairs, most recently as a Senior Manager in the Policy Group. Whilst working with Amgen, Catherine has worked in the areas of CMC in addition to clinical trials and post marketing activities.This has allowed a thorough insight into the unique ways that biologics are developed and their key features. Catherine has a special interest in pharmacovigilance requirements for biologics including biosimilars, as called out in the recent update to the EU Pharmacovigilance legislation, together with the need to ensure traceability of biologics from prescription to end-user, in addition to other issues which effect biologics and biosimilars. She is also involved with the European Trade associations at both EBE and EuropaBio.