In this session, we also aim to learn about the differences and similarities in regulatory requirements as well as challenges and opportunities for increased patient engagement - not to mention how COVID-19 situation has affected the regulatory work and potential repercussions to be experienced by the patient community.
Join us to hear about the current patient engagement developments from the regulators’ side, learn about the global regulatory dialogue and ask your questions to the panel.
Juan Garcia Burgos - Head of Public and Stakeholders Engagement Department-European Medicines Agency (EMA)
Daisaku Sato Ph.D., Chief Management Officer & Associate Centre Director for Regulatory Science, from The Pharmaceuticals and Medical Devices Agency in Japan (PMDA)
Lenita Lindström-ICH Assembly Chair and Senior Expert - DG Health and Food Safety (Medicines: policy, authorisation and monitoring)
Robyn Bent-Patient-Focused Drug Development Program Director, Center for Drug Evaluation and Research (CDER), FDA
Nicholas Brooke - Executive Director Patient Focused Medicine Development (PFMD)
Regulatory Review & Approval