2020台灣生技月 Bio Taiwan 生物科技大展

2020 台灣生技月 南港展覽館

講師

Jarret Su

Session 10 –New Frontiers in Therapeutics
Date: 24 July (Friday) 09:00 – 10:30 (GMT+8)
Venue: 701EF, 7F, TaiNEX2 / Online event platform


Jarret Su

Head of Healthcare and Life Science, KPMG in Taiwan/ Lawyer / Doctor

Jarret Su is Head of Healthcare & Life Science at KPMG Advisory Services Co., Ltd. and senior lawyer at KPMG Law Firm. He has over 20 years of clinical experience in medical practice, and also practiced law as a qualified attorney in Taiwan and in the USA. He had served as a member of IRB, School of Medicine, Washington University in St. Louis, USA, and now serves as a member of the Advisory Committee of Regeneration medicine, TFDA. Jarret provides advisory services to deal with the healthcare and bio-pharmaceutics issues, such as clinical trial, licensing, drug pricing, reimbursement, merge & acquisition, and IPO. Jarret is also in charge of the governmental projects focusing on regulation framework including Precision medicine, Cell therapies, and many healthcare related issues. The abundant experiences and great enthusiasm that Jarret possesses in the life science and healthcare profession has empowered him to be the pioneer and an expert in the relevant businesses.


Speech title & Synopsis

Regulatory Framework of Cell Storage and Processing Industries in Cell Therapy — From Taiwan to Global

With the execution of” Regulation of Implementation or Use of Specific Medical Technology, Inspection, and Medical Devices” in Taiwan, more and more patients opt for cell therapy, cells storage and tissues. In view of this, Cell Storage Unit gradually plays an indispensable role in cell therapy industrial chain. However, current regulatory of Cell Storage Unit seems not yet provided a clear guideline for Cell Storage Unit companies to construct and provide storage services. To elaborate that, we will analyze current regulatory of Cell Storage Unit in Taiwan. Followed by comparing regulatory in Japan, USA, and EU. Finally we will come up with a framework for Cell Storage and processing companies to provide services expected, including quality control system of cell storage, processing and traceability and resumes of cell product.