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[V5-S2] Oligonucleotide Therapeutics as Next Generation of New Medicine - Regulatory & Quality Considerations
Session Chair(s)
Takao Inoue, PhD
Chief of Laboratory, Laboratory of Oligonucleotide Therapeutics
National Institute of Health Sciences, Japan
The Oligonucleotide therapeutics is currently one of the hottest topics as a next generation of new medicines. It is also proposed for a new ICH topic by the Japanese regulators, and is just started to discuss the regulatory and quality considerations. In this session, the key experts from the regulator, industry and academia will discuss how the oligonucleotide-based drugs are assured from the regulatory and quality viewpoints.
Speaker(s)
Trend of Development and Regulation of Oligonucleotide Therapeutics
Takao Inoue, PhD
National Institute of Health Sciences, Japan
Chief of Laboratory, Laboratory of Oligonucleotide Therapeutics
CMC Considerations for Oligonucleotide Therapeutics
Kosuke Ito, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Reviewer
Examples and Issues of Analysis in Oligonucleotides Manufacturing
Hirokazu Nankai, PhD
GeneDesign, Inc., Japan
General Manager, Research & Development Division