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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, International Labeling
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)
Formal implementation of e-labelling in Japan
Tomoko Ohsawa, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director of Office of Informatics and Management for Safety
De-centralised Clinical Trial in China: Progress and Practice
Tong Guo
LinkDoc Technology (Beijing) Co. Ltd, China
Executive Vice President
Digital Endpoint Ecosystem & Protocols
Kai Langel
Janssen, Spain
Senior Director, Strategy and Innovation, Global Regulatory Policy