About Staff

．Institute for Information Industry / Science & Technology Law Institute / Legal Researcher (February 20, 2023 - )
．Taiwan Food and Drug Administration / Division of Medicinal Products / Reviewer (January, 2021 - February, 2022)
．Ivy Life Sciences Co., Ltd. / Clinical Department / Associate Research Fellow (January, 2020 - December, 2020)

Thesis
．Cheng-Yen Lu, The role of Cholesterol-Hydroxyecdysone-Vitellogenin Pathway in the Longevity of Honey bees (Apis mellifera) (2017)
．Cheng-Yen Lu, Energy metabolism of ambient temperature reduction in an annual fish (Nothobranchius rachovii) (2011)

Article
．Cheng-Yen Lu, Risk-based Classification and Regulatory Frameworks for In Vitro Diagnostic Devices: A Comparative Study of the EU, the United States, and Taiwan, Angle Health Law Review (Issue 107), 40-53 (2025).
．Cheng-Yen Lu, The Korea Ministry of Food and Drug Safety issues the world’s first Guideline on Approval and Review of Generative AI-based Medical Devices, Global Bio & Investment (June 24, 2025).
．Cheng-Yen Lu, Japan’s Ministry of Health, Labour and Welfare publishes Guideline on the Use of Medical Digital Data for AI Research and Development to Ensure Compliance, NCKU Medical Device and Technology Innovation Newsletter (Issue 17) (April 2025).
．Cheng-Yen Lu, UK MHRA conducts its first comprehensive analysis of clinical trial applications: What lessons can Taiwan learn, Global Bio & Investment (April 23, 2025).
．Cheng-Yen Lu, Korea establishes the National Biotechnology Committee to drive biotech development through three major transformations, Trade Insight Biweekly (Issue 666) (April 16, 2025).
．Cheng-Yen Lu, Korea releases the “Korea Bio-Great Transformation Strategy” on January 23, 2025, to advance infrastructure, R&D innovation, and industrial development, Global Bio & Investment (February 27, 2025).
．Cheng-Yen Lu, EU promotes “Qualification of Novel Methodologies” to support innovative technologies in drug development, Global Bio & Investment (November 1, 2024).
．Cheng-Yen Lu, U.S. FDA encourages the use of digital health technology in clinical trials with medicinal products, Global Bio & Investment (September 23, 2023)
．Cheng-Yen Lu, The Korea Ministry of Food and Drug Safety publishes the Guideline on Quality, Non-clinical and Clinical Assessment of Extracellular Vesicles Therapy Products, Global Bio & Investment (October 24, 2023)
．Cheng-Yen Lu, New EU Clinical Trials Regulation streamlines the application process for clinical trials across 27 Member States, Global Bio & Investment (November 23, 2023)
．Cheng-Yen Lu, Aichi Cancer Center Hospital conducted the first fully decentralized clinical trial in Japan, Science and Technology Law Review, 35(9), 13-14 (2023)

Professional speech
．Cheng-Yen Lu, Enhancing Taiwan’s Decentralized Clinical Trial Framework and Practice: Insights from International Experience, TMU Clinical Trial Insight 2025 — Pathway to DCT in Taiwan (September 26, 2025).
．Cheng-Yen Lu, Legal analysis on the application of AI and digital technologies in drug development, Symposium on Regulatory Compliance for Advanced Medical Technology Products (August 13, 2025).
．Cheng-Yen Lu, Legal analysis on the application of AI and digital technologies in clinical trials, 2025 Annual Clinical Trial Center Collaboration Platform – First Meeting Keynote Speech (May 27, 2025).
．Cheng-Yen Lu, Decentralised Clinical Trials in Taiwan – policy, ARCS Australia Conference (August 29, 2024).
．Cheng-Yen Lu, Legal analysis on the application of AI and digital technologies in drug development, Advanced Medical Products Legal Foresight Symposium (August 13, 2024).
．Cheng-Yen Lu, Global regulatory trends in precision tests, Precision health legal conference (August 16, 2023)
．Chen-Hui Chou & Cheng-Yen Lu, Current regulatory status and development of international telemedicine and decentralized clinical trials, Elementary training course in clinical trials with medical devices (March 23, 2023)

．ISO/IEC 27001:2022 Lead Auditor
．ISO/IEC 27701:2019 Lead Auditor
．ISO/IEC 42001:2023 Lead Auditor