[GBC7] R+T Meeting
- [GBC 7] ű
- [GBC 3] Ǿǰ
- [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
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!
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