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[] 373ȣ (2019.9.3.)
  • ۾
  • ۼ 2019-09-03 16:00:53
  • ȸ 7922
÷ 373.jpg
'19.09.03, ̿Ǿ

ȭ Ʈ Ǵ ̿Ǿǰ Դϴ.
α ҽ
ľó, Ǿǰ ߿
2019 Ǿǰȭȸ(ICH) ̵
(ľó) 2019 ICH ̵
  • : , ̿Ǿ Ǿǰ ICH ̵ ٽɺо  
  • Ͻ: 2019 9 4() - 5() *9 6() : DIA-NIFDS ICH Workshop
  • : ׷ư,
  • ֿ
    (9/4) ǰо : ̿Ǿǰ , ̷
    (9/4) պо : ӻ , Ҽ
    (9/5) ȿо : ӻ , ӻ
    (9/5) о : , ฮ  
KoBIA's comments
- 2019 ICH ̵ () մϴ.
- ڷ 켱 Դϴ.
- ڷ (ǥڷ) Ȩ ٿεϽ ֽϴ.
Ǿǰ 鿪 򰡿 ̵
Ǿǰ ֽ ݿ (2019.07.31.) ε
Ǿǰ 鿪 򰡿 ̵ ֿ
  • Ǿǰ 鿪 ִ ε (ȯ ȯ / ǰ)
  • 鿪 ӻ
  • ü 鿪 Ȯ ( / ü / 븮̼)
  • Ǿǰ ü Ư м
  • 鿪 ӻ󰳹 (ൿ / ȿ / 鿪  )
  • 鿪 α׷
  • η
    - 鿪 ü
    - ü Ư м ȵǴ
    -  鿪 α׷
Ǿǰ (09/02)
  • Ǿǰ(ǥ1)
  • ߴܰ Ǿǰ(ǥ2)
  • Ǿǰ 濬 
    - 207 ָ(ֻ)
    - 258 ̻ø(ֻ)
˱ ȳ
  • ſ ùٸ

  • - ÷翣 ()
    - BCG (ٿ)
  • ֿ䳻
    - , , ñ
    - ̻ ߻ ó
KoBIA ˷帳ϴ
̿IT÷
2019 ű ȳ(, ƸƼ)
̿IT÷ 19
ƸƼ ̿Ǿǰ ű
̿ ٶϴ.
'̿IT÷' ؿ ̿Ǿǰ
(̵ /) ϰ  ִ ƮԴϴ.
ڿ  
Ȱ űα׷ (~9/11)
ű α׷
  • α׷ Ʈ
    Ʈ ( ) ( ) ߼߰߱ (ܱ⺸) Ư (ſ뺸_) űԴü (Ժ ؿܻ) ų (ؿܼ Ư)   
  • 9 11() ѱ̿ȸ åºη ȸ
    * åȰ ٸ
ӻ/㰡 ҽ
ӻ 
  • Ro 712-1661/F01-01 (PD1-TIM3) /༺ /Ǵ ̼ ȯڿ PD-1/TMI-3 Ư ü RO7121661 , ൿ Ȱ ϴ , ٱ, 뷮 Ȯ 1  / 1 ѱν / 2019-09-02 
  • ÷(Eteplirsen) / 51 Űο ̰ ִ ༾ ̿ ȯڸ 뷮 ÷(Eteplirsen) 뷮 ȿ ϴ , , 뷮 Ȯ ӻ / 3b̿ġ쾲ڸ ȸ / 2019-08-30 
ؿ 㰡 (̱)
  • NOURIANZ NDA #022075 ISTRADEFYLLINE /Ź /KYOWA KIRIN (08/27/2019)
  • HARVONI NDA #212477 / LEDIPASVIR;SOFOSBUVIR / ſ뷮 / GILEAD SCIENCES INC (08/28/2019)
  • SOVALDI NDA #212480 / SOFOSBUVIR / ſ뷮 / GILEAD SCIENCES INC(08/28/2019)
  • RIOMET ER NDA #212595 / METFORMIN HYDROCHLORIDE / ſ뷮 / SUN PHARM INDS LTD  (08/29/2019)
ؿ ӻ  (clinicaltrials.gov  2019.08.27~2019.09.02)
<̱>
  • NCT04035005 / A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive / Multiple Sclerosis Multiple Sclerosis, Primary Progressive / Ocrelizumab, Placebo / Hoffmann-La Roche / Phase 3 
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KoBIA Ȩ ü Ȯ
EVENT
2019 AHC Workshop
  • 9 3(ȭ) - 4()
  • ڿ ۷Ȧ 300ȣ
  • AHC:  ƽþơ ü ȭ(Asia-Pacific Economic Cooperation Harmonization Center)
2019 ̿佺Ƽ
  • 9 3(ȭ) - 4()
  • CV
  • 8 31ϱ
NHS ӻ󿬱
  • 9 17()
  • ̿ ȸǽ
2019 Ϲݱ Ʈ ŷ Ưȭ
  • Ǿǰ: 9 23()
  • ѱǺη°߿ ǻ 9 3ǽ
SR & META Analysis
ǹǽ ⺻
  • Ͻ : 9 30(), ѱǺη°߿ ǻ 9 2 ǽ
  • ֿ䳻: ž Ƿ() ü ӻ (ٰŹȰħ(EBRM) META м ǽ(RevMan) )
2019 ѹȸ ߰мȸ
  • 10 11()
  • 縯б ǻ 2 밭
  • 10 6()
  • ̿ ȭ о /п ǹ߽
  • 10 10() - 11()
  • (뱸) 3 ǽ
  • ,
2019 ȭ
  • ġŰ 鿪ġ ̷
  • 11 7() - 8()
  • ȭ ϴϿȭ
  • ~10 31()
Ÿ ҽ
# (KPMG) Pharma Outlook 2030 : From Evolution To Revolution [Click]
# The Small Molecule Antibiotics Pipeline : 2014 - 2018 [Click]
# SCM, ... ǥ [Click]
ѹ, , ؽ, " ̿ĸ" [Click]
SK CMO 3 ա2025 10 ġ [Click]
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Vol. 93 (September 2, 2019)
374ȣ (2019.9.10.)

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