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2014 ̿ùз ɻ ũ з ̳
û 1970.01.01~1970.01.01 2014.08.28~2014.08.28
ǰǾǰó ۻд ߾Ļ ȸǽ(1) ð 9:30~16:00

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ǰǾǰ򰡿 2014 NIFDS Biosimilar Workshop Ʒ Ͽ,

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2. Ͻ: 2014. 8. 28() 9:30~16:00

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09:3010:00

REGISTRATION

10:0010:10

Opening Remarks

Dr. Yeowon Sohn

(Director General,

Biopharmaceuticals & Herbal Medicine Evaluation Department, MFDS)

10:1010:50

Topic 1: The current development status of biosimilar

products

Dr. Hyukjae Lee (Celltrion)

10:5011:30

Topic 2: Review and approval system of biosimilar

products in Korea

Dr. Jeewon Joung (MFDS)

11:3013:00

LUNCH

13:0013:40

Topic 3: Review and approval system of biosimilar

products in EU

Dr. Gabriele Reichmann (PEI)

13:4014:10

Questions & Answers

14:1014:30

REFRESHMENT BREAK

14:3015:00

Topic 4: Current status of Korea guidelines on the

evaluation of biosimilar products

Dr. Kyungtak Nam (MFDS)

15:0015:30

Topic 5: Current status of EU guidelines on the

evaluation of biosimilar products

Dr. Gabriele Reichmann (PEI)

15:3016:00

Questions & Answers

 

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