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2019 AHC Biotherapeutics Workshop з ̳
û 2019.08.19~2019.08.30 2019.09.03~2019.09.04
ڿ ۷Ȧ 300ȣ ð
÷ Draft agenda_AHC Biotherapeutics Workshop_Agust13.pdf

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AHC

   
APEC ̿Ǿǰ ε 2020 
̿Ǿǰ о APEC ȸ ý ȭ ޼ ǥ 2012 ϴ.
 
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APEC RHSC 츮 ǥ ǵ , 
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2019 APEC Harmonization Center 
Biotherapeutics Workshop
Biotherapeutics Roadmap 2012-2019: 
Gap Analysis and Assessment of Progress Made Towards Convergence
AHC?
ƽþơ ü ȭ(Asia-Pacific Economic Cooperation Harmonization Center, AHC) 󼳱ⱸ APEC ǾǰǷ 㰡 ü ȭ 2009 ľó Ͽ
  • Ͻ: 2019 9 3(ȭ) - 4()
  • : ڿ ۷ 300ȣ
  • : ǰǾǰó AHC
  • α׷ û ȳ Ʈ Դϴ.
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  • [Introductory] APEC RHSC 2020 Vision and the Accomplishment
    Overview of APEC RHSC 2020 Vision and the Strategic Approaches; Share the results of the joint AHC-LSIF project to track key performance indicators (KPIs) measuring progress towards regulatory convergence in the APEC region.    
  • [Session I] APEC RHSC Biotherapeutics Roadmap
    Overview of the Biotherapeutics roadmap; Highlight major outcomes from the past 7 years of roadmap activities including CoEs    
  • [Session II] Global Impacts of the APEC RHSC Biotherapeutics Roadmap
    The impact of the work of Biotherapeutics Roadmap in the development and adaptation of the global guidelines as well as leveraging the initial concept of regulatory capacity-building
  • [Session III]
    Part A: Evolving the APEC Biotherapeutics Roadmap

    Considerations for broadening the scope of work areas in Biotherapeutics and Innovated Technologies for Manufacturing Biotherapeutics
    Part B: Evolution of the APEC Biotherapeutics Roadmap
    Working together with other PWAs and initiatives and navigating the synergy
  • [Session IV] [Panel Discussion] 
    Pre-assessment of the APEC regulatory convergence in Biotherapeutics
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2019 APEC Harmonization Center Biotherapeutics Workshop
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