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Tokyo Big Sight

11 nov 2018 9:30 a.m. - 13 nov 2018 5:40 p.m.

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

15th DIA Japan Annual Meeting 2018

Innovative technologies such as AI, big data/genomics, and cell/gene therapies are poised to transform healthcare product development across the globe – join us to discuss these topics.

[V5-S2] Oligonucleotide Therapeutics as Next Generation of New Medicine - Regulatory & Quality Considerations

Session Chair(s)

Takao  Inoue, PhD

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

Trend of Development and Regulation of Oligonucleotide Therapeutics

Takao Inoue, PhD

National Institute of Health Sciences, Japan

Chief of Laboratory, Laboratory of Oligonucleotide Therapeutics

Kosuke  Ito, PhD

CMC Considerations for Oligonucleotide Therapeutics

Kosuke Ito, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Principal Reviewer

Hirokazu  Nankai, PhD

Examples and Issues of Analysis in Oligonucleotides Manufacturing

Hirokazu Nankai, PhD

GeneDesign, Inc., Japan

General Manager, Research & Development Division

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