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DIA/FDA Oligonucleotide-Based Therapeutics Conference
Breakfast Plenary Session: Global Regulatory
Paul C. Brown, PhD
- ODE 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.
Draft Guideline for Non-Clinical Safety Evaluation of Oligonucleotide Therapeutics in Japan
Yoko Hirabayashi, MD
- Director, Center for Biological Safety & Research
- National Institute of Health Sciences (NIHS), Japan