Development & Regulation of CT Products in Korea - Digital Recording (Mar 27/14)
The Development & Regulation of Cell Therapy Products (CTPs) in Korea
Organized by the ISCT Asia Regional Executive Committee.
Please open the PDF slide and click the link on the first page to access the Digital Recording.
Date: Thursday, March 27, 2014 in North America/Europe and Friday, March 28, 2014 in Asia
Chair: Steve Oh, PhD, Bioprocessing Technology Institute, Singapore
Speakers: Jaeseung Lim, PhD, Samseong Bio, South Korea
The trends in medicine are changing from one of treatment of diseases into enhancing our well-being. This new paradigm is known as 4P medicine (Predictive, Preventive, Participatory, and Personalised). One example of the 4P medicines would be a cell therapy product.
Korea is one of the leading countries developing cell therapy products. Since 2001, more than 10 cell therapy products have been approved by the Ministry of Food & Drug Safety (MFDS*). Therefore, several Korean cell therapy companies have developed significant experience in producing clinical grade cell therapy products,which will be shared in this webinar. The manufacturing CTPs and maintaining GMP for CTPs are not easy tasks. In addition, the logistics for CTPs is very different from traditional chemical drugs or biologics. The challenge in getting reimbursement from national health insurance is also one of the most difficult hurdles when developing cell therapy as a medicine. The regulation and current development of cell therapy products in Korea will be discussed.
Background: The regulation of Cell Therapy Products (CTP) in Korea, Current Status of Korean Cell Therapy, etc.
Key Learning Objectives:
- Understanding of Korean Regulation
- Example of developing a cell therapy product
- Future development of Korean CTP markets
*KFDA changed its name to MDFS last year.