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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

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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.





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