About Staff
Lu, Cheng-Yen is currently working as a legal researcher, mainly implementing legal plans related to biomedical science and technology, such as precision medicine, regenerative medicine, contract development and manufacturing organization. Specializes in Medical Care Act, Pharmaceutical Affairs Act, Clinical Trials Regulations.
．Doctor of Philosophy, Graduate Institute of Biomedical Sciences, Chang Gung University
．Master of Science, Graduate Institute of Biomedical Sciences, Chang Gung University
．Bachelor of Science, Department of Biomedical Sciences, Chang Gung University
．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, 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, 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