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Session 3: Check Points of Biologics Development
Session Chair(s)
Ho-Sang Jeong
NIFDS, Korea, Republic of
Speaker(s)
Session 3.1 :Considerations and Challenges on CMC-related Issues for the Early-Stage Development of Biotechnology Products
Changjin Lee, PhD
Hugel Inc., Korea, Republic of
CTO
Session 3.2 : Regulatory Inspections for Data Integrity and Human Protection
SeongEun Cho
FDA, United States
Director
Session 3.3 : Pharmacology and Toxicology Testing of Biologics from a Regulatory Perspective
Yangmee Shin, PhD
KWiSE, United States
Sr. Pharmacologist
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