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Session 3: Digital Technology Advances The Modernization Of Regulatory Science & Drug Development
Session Chair(s)
Fengyun (Vicky) Han
Senior Director, Head of Regulatory Policy for Asia Pacific, Johnson & Johnson Pte. Ltd., Singapore
Rie Matsui, RPH
Senior Director, Regional Labeling Head for APAC, Pfizer R&D Japan G.K., Japan
Digital is a very dynamic and developing in a very fast manner, it has been wildly applied in almost everywhere and has been accelerated during the COVID-19 pandemic. the pharmaceutical industry and academia have been using many digital tools to accelerate the drug R&D and clinical trial development, and regulator is leveraging the digital technology to improve its drug review and supervision system etc. In this session, will focus on updating of digital technology to advance the regulatory system modernization, and the transitioning to e-labelling by using 2D barcode and structured format, and digital endpoint to facilitating the clinical trial development and cloud based system
Speaker(s)
Tomoko Ohsawa, PHD
Director of Office of Informatics and Management for Safety, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Tong Guo
Executive Vice President , LinkDoc Technology (Beijing) Co. Ltd, China
Kai Langel
Senior Director, Strategy and Innovation, Global Regulatory Policy, Janssen, Spain
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