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Breakfast Plenary Session: Global Regulatory
Session Chair(s)
Paul C. Brown, PhD
Associate Director for Pharmacology and Toxicology, OND, CDER
FDA, United States
Laurence Whiteley, DVM, PhD
Senior Director, Global Pathology Team Leader
Pfizer Inc, United States
Representatives from the Pharmaceutical and Medical Devices Agency (PMDA) of Japan will present their proposal for a regulatory guidance for oligonucleotide therapeutics. Discussion will focus on the overall approach and whether aspects can be more widely applied. The information presented may also support discussion in other sessions of the meeting.
Speaker(s)
Draft Guideline for Non-Clinical Safety Evaluation of Oligonucleotide Therapeutics in Japan
Yoko Hirabayashi, MD
National Institute of Health Sciences, Japan
Division Head