2013 ÷ 籹 û ũ | з | ̳ | |
---|---|---|---|
û | 1970.01.01~1970.01.01 | 2013.10.01~2013.10.02 | |
ǷŸ Ļ ȸǽ | ð | 09:00~17:00 | |
÷ | Agenda.doc |
ǰǾǰó ġ [2013 ÷ 籹 û ũ] Ʒ մϴ.
Title: Review and Approval of Advanced Therapy Products
* Subtitle; Preclinical assessment of cell therapy products
Date: 2013.10.1(ȭ) 14:00~17:00, 2() 09:00~17:00
* ܺλ 101 ϸ, , 뿪 մϴ.
Venue: ǷŸ Ļ ȸǽ
Agenda
Day 1 | Focusing on general regulation of Advanced Therapy products (public session) | |
14:00-14:40 | General considerations for advanced therapy products in Europe | Dr. Beuneu Claire, EMA |
14:40-15:20 | General considerations for advanced therapy products in Canada | Dr. Peter Ganz, Health Canada |
15:30-16:10 | General considerations for advanced therapy products in Korea | Dr. Mi-ra Choi, MFDS |
16:10-17:00 | EU Regulatory perspectives on ATMP | Prof. Dr. Klaus Cichutek, PEI |
Day 2 | Meeting among regulatory authorities (closed session) | |
09:00-11:30 | Session 1. Issues on preclinical assessment of cell therapy products * U.S. FDA will participate during the first session via teleconference. | U.S. FDA, EMA, Health Canada, NIFDS/MFDS |
14:00-17:00 | Session 2. Case discussion on the preclinical assessment of cell therapy products | EMA, Health Canada, NIFDS/MFDS |
* 迡 Ͻþ ؿ ÷ ִ ڸ Ǿ մϴ.
û Ͻô в ѱ̿Ǿǰȸ å (02-725-8435/hwk@kobia.kr) ֽø ȳص帮ڽϴ.
Discover the real world of gambling for Korean players at bons casino, a licensed online casino! Hundreds of exciting games for every taste are waiting for you. From classic slots with reels to games with live dealers. BONS Casino offers registration bonuses, free spins, deposit extra funds for games with live dealers, and other promotions! Play and score at BONS CASINO now!