Ana Montoya Alarcon

Head of Global Regulatory Systems Operations at Daiichi Sankyo

Advisor, Speaker

Ana leads the Regulatory Systems and Operations team at Daiichi Sankyo, where her team is responsible for all Global and Local Regulatory systems (including RIM) and projects such as IDMP, labelling optimization, data governance, etc. to support the digital transformation journey at Daiichi Sankyo globally. Before that, part of Novartis & Sandoz, leading different initiatives, such as RIM project in terms of System Design and Delivery or Document Management System for R&D. Before joining the RIMS space, previous experience in Regulatory Affairs in consulting and in the AEMPS (Spanish Agency of Medicines and Medical Devices). Graduated in Pharmacy (Msc.) and Master in Clinical Trials and Medical Affairs. Ana’s focus is on enabling data-driven strategies across the regulatory landscape and having strong commitment to continuous improvement.