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Symposium 10: Medical Device Epidemiology in Asia: Examples and Challenges

Tracks
Track 2
Monday, October 14, 2024
8:30 - 10:00
South Clinical Research Building

Details

The use of medical devices in clinical practice is rapidly increasing, including new modalities like Software as a Medical Device (SaMD). These devices can compete with or complement pharmaceuticals, making their interaction with drugs a key theme in pharmacoepidemiology. However, unlike drug epidemiology, evaluating medical devices is challenging due to issues like identifying devices in databases. In this session, speakers will present case studies on invasive cardiovascular devices, robotic surgery systems, and SaMD, demonstrating how studies are used for regulatory and reimbursement purposes. Participants will gain insights into Asia's regulatory environment, learn best practices, and discuss strategies to improve study integration into regulatory frameworks. The session will offer valuable insights into how epidemiological studies for medical devices may be conducted in Asia. By learning the methodologies and challenges faced in Japan and China, participants can identify common issues that also affect their own countries, such as difficulties in identifying devices within existing databases and the need for special considerations due to facility or operator factors. The session will also explore how these studies are utilized for regulatory and reimbursement purposes, providing a framework that can be adapted and harmonized across different nations.


Speaker

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Yongjing Zhang
Global Epidemiology, Johnson & Johnson

Presenter

Biography

Dr. Zhang has been working on Real-World research in pharmaceutical and medical device industry for over 15 years. He is dedicated to promoting global universal standards for electronic health databases in the Asia-Pacific region, practicing emerging theories and methods in epidemiological research, and advancing Real-World Evidence guided by the value of clinical practice. He leads a team in establishing database framework and scientific research collaboration in multiple countries in the Asia-Pacific region, providing scientific consultation and training on Real-World research, and conducting cross-national Real-World studies in multiple therapeutic areas to support new indication expansion, pre- and post-market regulatory requirements, evaluation for drug safety and rational drug use in scientific management throughout the entire product lifecycle. At present, he has more than 20 scientific papers and over 50 conference abstracts published in international academic journals and conferences, which have been widely recognized by academic and regulatory institutions. Prior to Johnson & Johnson, he worked in the Epidemiology Department at Novartis, where he was responsible for providing epidemiological support to various functions in the Greater China region, as well as assisting the R&D department on scientific research collaboration with external KOLs.
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Dr. Hiraku Kumamaru
Associate Professor
University of Tokyo

Presenter

Biography

Hironobu Tokumasu
Ohara Healthcare Foundation Clinical research Center

Presenter

Biography

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Dr Mary Ritchey
Chief Scientific Officer
CERobs Consulting

Presenter

Biography


Moderator

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Hiraku Kumamaru
Associate Professor
University of Tokyo

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Mary Ritchey
Chief Scientific Officer
CERobs Consulting

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