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(Webinar) Decentralised Clinical Trials in Taiwan – policy and practice
活動介紹
The Taiwan Food and Drug Administration (TFDA) issued the Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials in June, 2023.
Dr Lu will discuss the guidance which aims to cover a wide array of decentralized measures; they aim to increase trial subjects’ willingness to participate in trials, reduce the need for in-person visits to clinical trial sites, enhance real-time data acquisition during trials, and enable clinic sponsors and contract research organizations to process data remotely.
In addition, Tina Sun, who is the President of the Taiwan Clinical Research Association (TCRA), which includes many of the major pharma companies in Taiwan, will outline experience to date in the conduct of decentralised trials in Taiwan.
- Date｜29 August 2024
- Time｜10:30-11:30 AM
- Venue｜Online
- Who Can Register?｜Anyone
活動議程
Speaker details: Dr Cheng-Yen Lu, Science & Technology Law Institute, Institute for Information Industry
Cheng-Yen Lu 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
Tina Sun, Taiwan Clinical Research Association (TCRA)
Tina Sun is a highly educated professional with a background in Pharmacy from National Taiwan University and an EMBA from National Taiwan University of Science and Technology. Currently, she holds multiple positions, including Study & Site Operations (SSO) Country Head for Global Clinical Operations (GCO) at Novartis, Country Network lead for TransCelerate Biopharma Inc. in Taiwan, and President of the Taiwan Clinical Research Association (TCRA).
Her specialties lie in global clinical trials operations and management, frequently speaking on clinical trial topics in GCP training programs, universities, and conferences.
【About ARCS Interest Area meetings serve】
ARCS Interest Area meetings serve as dynamic and collaborative webinars where professionals and experts come together to explore and discuss the latest trends, challenges, and innovations within our respective fields. While we're currently in the process of finalising the details, including the specific topic and esteemed speakers, we can assure you that this webinar will offer valuable insights and the chance to connect with like-minded individuals who share your passion and expertise.
