Workshop 2 – Clinical Trials for Advanced Therapies
Date: 24 July (Friday) 12:20 – 13:50 (GMT+8)
Venue: www.bioasiataiwan.com - Online event platform
Dr. Tang is currently the Section chief of Regulatory science, Center of consultation at Taiwan Center for Drug Evaluation.
Since joining in the regulatory science field in 2010, Dr. Tang has been involved in various projects. She is an experienced medical reviewer in evaluating market authorizations and clinical trial applications of medical devices, drugs, and advanced therapy medicinal products. Prior to this career, she was a physician specialized in physical medicine and rehabilitation for about 10 years.
A major part of her work at present is to provide scientific advice regarding product development to domestic and international biotech companies, pharmaceutical companies, non-government organizations and research institutes, and to assist government agencies in evaluating biopharmaceutical industry development programs and budget, also to help formulate policies, regulations and guidelines related to biopharmaceutical industry and trade. She is a frequent invited speaker in various domestic and international conferences to introduce the regulatory environment in Taiwan.
Speech title & Synopsis
Since September 2018, there has been a regulatory innovation regarding advanced medicinal products in Taiwan. Currently the regulatory pathway for regenerative therapy medicinal products is a dual-track system, the purpose is to cover urgent patient need and product development at the same time. In today’s presentation, I would like to introduce the dual-track system and review considerations regarding clinical trials and treatment plans.