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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)
Takao Inoue, PHD
Chief of Laboratory, Laboratory of Oligonucleotide Therapeutics, National Institute of Health Sciences, Japan
Trend of Development and Regulation of Oligonucleotide Therapeutics
Kosuke Ito, PHD
Principal Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
CMC Considerations for Oligonucleotide Therapeutics
Hirokazu Nankai, PHD
General Manager, Research & Development Division, GeneDesign, Inc., Japan
Examples and Issues of Analysis in Oligonucleotides Manufacturing