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[] [GBC 2019] Vol.2 ű ...
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  • ۼ 2019-06-13 11:45:35
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[GBC7] R+T Meeting

[2019 ۷ι ̿ ۷] Ʈ ҽԴϴ.
Ʈ Ǵ ̿Ǿǰ ҽ غ! [Click]

  GBC 繫 😈 ۼ ǰǾǰó ذ ƴ ϴ.
  1.  [GBC 7] ű
  2.  [GBC 3] Ǿǰ  
  3.  [Networking] ̺Ʈ Ұ 

̿Ǿǰ Ȳ  

4 ô Ҿ ֱ ϰ ִ ̿Ǿǰ , , 㰡 ݿ Ǿ з ٲٰ ֽϴ. Ӱ GBC7 ű ǥ 4 ô ٽ ٷ Դϴ.  ͵ ?
#1. ӻ (Continous Manufacturing, CM)

̼ٿȭ 'Ȳݾ ' 𸣴 ϴ. Ŵ ڲ Ѻ ǽ̳ ϴ ϰ ȸ ֽ ͵ Ȳݰ ˴ϴ. ̵ ϱ?
̵ Input Output Ȯϰ Ǵ Ӽ մϴ. ǰ ϰǰ Ǵ ǰ ϴ Ư ֽϴ. ̿Ǿǰ 굵 Ȳݰ ? ̹ ߰, ٱ ϰ ֽϴ. ֿ ٸ ϴ () ϰ (Control, QbD ٽ) ϰ ϰ, ǰ , ϰ . ٷ ӻ Դϴ.
̰ ⼺ ٿ ߽ð Ű, ǰ ñⰣ , , DzƮ ȿ Ű ַǵ Ȳ ؼ غؾ ֽϴ. Ⱓ , μ ȿ ˻, ǽð PAT, ¶ ͸ ȯ ؼϱ Դϴ. [GBC7]ű ù ° ǿ CM Ե ʸ Ȯغ, ȯ濡 ִ غϴ.
#2. ǻ뵥(RWD) ǻ(RWE) 

4 Ϳ ۵Ǹ, 4 ٽɺо߷ ղ コɾ Ϳ Ǿ ֽϴ.(4 , ٽ 'ʿ' ˰ ôٸ, GBC Archive 湮ϼ!) 
コɾ о߿ ʹ Real World Data(RWD, ǻ뵥) Real World Evidence(RWE, ǻ) ǥ˴ϴ. RWD ǰ (Electronic health records) ⺸ 䱸(Claims) û(billing) Ȱ ǰ (Product and disease registries) ǰ ͸ (Health-monitoring devices) ϸ RWE RWD м ٰڷḦ մϴ.
'' Ȯϰ '' ¸ ִ ǥ Ǿ ӻ ϰų, ǽ , ͸ ϰų, Ǵ , ڵ '' ȿ Ǿǰ ϴµ ֽϴ.
[GBC7]ű ° ǿ RWD RWE ̿ ȯ ġ , ο ߰, õ ŭ Ǿ Ȯϰ, 츮 ư մϴ.

#3. ü (Blockchain Technology) 

ȭ ǽ Ϸ(2001) پ ϵ , ȫä ϵ ij ϴ ϴ. ȭ ġ ¥ Ѵٸ Դϴ. RWD, RWE Ƿ ͸ ̾߱ϴ ǻ , ǰ, ̿Ǵ ƴұ ˴ϴ. ϰ ȣ , 4 ɸ ϱ? 
[GBC7] ű ǿ P2P Ʈũ л (DLT) ϴ ȣȭ Ʈũ ü Ư ˾ƺ, ü Ե ̻ PHR (Personal Health Records, ΰǰ) Բ ü ̿ PHR ÷ Ȳ Ǵ ̷ 캾ϴ.

׾üǾǰ Ȳ ׾ġ ̷ 

迡 ϸ ų 20 ̻ ް , 7 ϰ ֽϴ. ű ϰ ? ü 鿪 ý ϴ ü ׾üǾǰ(ADC, Antibody-drug conjugate) ֽ Ȯغ, ġʿ ̷ 캾ϴ.
FDA Ǿǰ 㰡Ȳ ֽ
Maria Teresa Gutierrez Lugo, US FDA

Ǿǰ ǥȭ õ WHO
(WHO)

R+T Meeting

MSD, Z̿, ̹̿, SCM, ĸ, ťƼ, ťý, ̿׷, ̿, ƿ, PlantForm Corporation ̱ȸ(USP),  Z𺴿 پ о ְ ڸ Դϴ. 
GBC 2019 ϴ ֿ ι/ ϰ, Ͻ ߱غ! 
#R+T Meeting
  • Ͻ: 2019 6 27() 1(10-12) / (12-14) / 2(14-16)
  • : ׷ ƼŻ ĸ (5F)
  • GBC 2019 Ͻ R+T Meeting ûּ!
1:1 Ǵ #GB-Communication !
  • Ͻ: 2019 6 27() - 28(), 10ú 5ñ
  • : ׷ ƼŻ ĸ ī̼(5F)
  • Ϻ ð 뿪 / 繫ǰ, ٰ, !

  GBC 2019 11.3% $%name%$԰ ٸ ֽϴ!
̿ ľó, GBC ; е ãƺ!

#GB-Communication û

GBC 2019 6 19() ˴ϴ.
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