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Vol. 93 (September 2, 2019)
  • Data 2019-09-02 18:39:45
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September 2, 2019

A Biweekly Updated Biopharmaceutical News Service
ICH Guideline Training 2019
The MFDS has supported the development of the capacity building
of drug developments with international standards

As one of the ICH member countries, it aims to fulfill its guidelines, enhance their capabilities, and bridge the gap between global standards and local conditions through this professional education. Plus, this program will deal with some parts of ICH guideline should be preferentially handled, share the current mechanisms of safety management reflected the international regulatory requirements, and seek ways to relieve industries’ concerns of ICH guideline implementation.
  • Date: September 4 (WED) - 5 (THU), 2019
  • Venue: Convention (4F) & Emerald Hall (3F), Grand Hilton Seoul
  • Hosted by the NIFDS
  • Organized by the KRPIA and KoBIA
Main Contents
  • Quality (9/4): Q5A(R1),Q5B/D, Q6A/B, Q1A/D
  • Multidisciplinary (9/4): M3(R2), M7(R1)
  • Safety (9/5): S3A (QnA), S3B, S7A/B
  • Efficacy (9/5): E2A/B(R3), E9
KoBIA e-Brochure
KoBIA shall continue to sophisticate expertise in its member services
and to make efforts for further biopharmaceutical industrial development
Major Contents
  • Mission and Vision
  • Organizational Chart 
  • Key Activities
  • Membership Benefits and Application Process
2019 AHC Workshop
Date: September 3, 2019
Venue: Conference Hall 300, CoEX, Seoul
AHC: Asia-pacific Economic Cooperation Harmonization Center
2019 Osong Bio Festival
Biopharmacueticals: From Discovery to Development
- Date: September 3-4, 2019
- Venue: Osong C&v Center
ICH Workshop
NIFDS-DIA ICH Workshop on Pharmacovigilance: Best Practice in PV 
- Date: September 6, 2019
- Venue: Grand Hilton, Seoul
4th Floor, Wonil Building, 10, Nambusunhwan-ro 333-gil, Seocho-gu, Seoul, Korea   
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