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Session 11: PMDA Highlight - Recent Publication of Japanese Guideline for Non-clinical and CMC Topics Related to Oligonucleotide Medicines
Session Chair(s)
Scott Henry, PhD
Senior Vice President, Nonclinical Development
Ionis Pharmaceuticals, Inc., United States
This session will briefly review the Japanese Guideline regarding preclinical assessment of oligonucleotide medicines. This session will also introduce the outline of the points to consider document, and review issue related to CMC in Japan. Common questions will be addressed pertinent to this class of therapeutics.
Learning Objective : At the conclusion of this session, participants should be able to:
- Learn the basic concept of non-clinical safety evaluation required for the development of oligonucleotide therapeutics in Japan
- Explain the outline of points to consider document regarding CMC of oligonucleotide therapeutics in Japan
Speaker(s)
Points to Consider Document on CMC of Oligonucleotide Therapeutics in Japan
Kosuke Ito, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Reviewer
Japanese Perspective on Non-clinical Safety Assessment for Oligonucleotide Therapeutics
Kazushige Maki, DVM, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Scientist, Toxicology
Non-clinical Safety
Kiyoshi Kinoshita, PhD
MSD K.K., Japan
Manager, Regulatory Affairs, Area Japan Development
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