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GPKOL Symposium
Global expansion platform for Korean pharmaceutical companies to promote collaboration at the national level and share the latest information
 
Title 7th GPKOL International Symposium 2018
Overview 7th GPKOL(Global Pharmaceutical Key Opinion Leaders) International Symposium this year will focus on GMP & CMC strategy for pharmaceuticals to help Korean pharmaceutical companies to develop products with global commercial potential. Experts with years of experience in regulatory authority and multinational pharmaceutical companies will share their expertise and insights about how to successfully access for global pharmaceutical market regarding phamaceuticals production. This symposium will serve as a learning as well as networking opportunity for the participating companies with their sights set on going globally.
Date 2018. 5. 10 (Thu) 09:30~18:00
Venue Rm. 402, 403
Organizer - Hosted by Ministry of Health and Welfare(MoHW)
- Organized by Korea Health Industry Development Institute(KHIDI)
preliminary
participant
Korean medical device manufacturers
 
Program
Time Program Presenter
09:00∼09:20 Registration
09:20∼09:30 Opening Remarks
Congratulatory Remarks
Session 1 : Global Trends, Challenges and Strategies
09:30∼09:35 - Introduction of Session 1 Chair: Shinhong Kang, Ph.D.
(Senior Vice President, Handok)
09:35∼10:15 Keynote Speech
- Overcoming Challenges of CMC
  Development and Manufacturing of
  Innovator Drugs
Soojin Kim, Ph.D.
(Vice President, Hanmi pharmaceuticals)
10:15∼10:55 - CGMPs for Biologics Versus Small
  Molecules
Kathleen Retterson
(Vice President, Spectrum Pharmaceuticals)
10:55~11:35 - Enhanced Process Development and
  Manufacturing Through Continuous
  Processing
Otute Akiti, Ph.D.
(Head of CMC, BlackThorn Therapeutics )
11:35~11:45 Q&A
11:45∼12:50 Lunch
Session 2 : Drug Substance & Drug Product Development Strategies
12:50∼12:55 - Introduction of Session 2 Chair: Hyei-jha Chung, Ph.D.
(Chief Manufacturing Officer, Vivozon)
12:55∼13:35 - Regulatory Guidance and CMC
  Aspects of Drug Substance
  Development with Emphasis on ICH
  Quality Guidelines and Impurity Control
Heewon Lee, Ph.D.
(Director, Boehringer-Ingelheim)
13:35∼14:15 - Present and Future Drives for DS
  Development and Manufacturing
Jale Muslehiddinoglu, Ph.D.
(Senior Principal Scientist,
J&J Janssen)
14:15∼14:55 - Formulation Risk and Opportunity for
  Oral Delivery of Poorly Soluble Drugs
Duksoon Choi, Ph.D.
(Founder, Choi Laboratories)
14:55∼15:35 - Product development and CMC aspects
  of transdermal delivery systems
Cheeyoub Won, Ph.D.
(Associate Director, Allergan)
15:35∼15:45 Q&A
15:45~15:55 Coffee break
Session 3 : GMP & CMC Regulatory Strategies
15:55~16:00 - Introduction of Session 3 Chair: Mahmoud Alqawasmeh
(KHIDI)
16:00~16:40 - GMP and Data Integrity Challenges to
  Global Pharma in 2018
Murali Gavini, Ph.D.
(President, DPLCM)
16:40~17:20 - Conceptual and Historical Overview:
  GMP, Process Validation, Quality
  System, Quality by Design
Charles Ahn
(Principal Consultant, Aegis Beacon Consulting)
17:20∼18:00 - How to do CMC for Phase 1 IND for US
  FDA
Kay Olmstead, Ph.D.
(Consultant, TKO Pharmasolution)
18:00∼18:10 Q&A
18:10 Close
 
Contact
TEL: +82-10-9258-0731 / Email: ssoomkim@nate.com