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Bethesda North Marriott Hotel and Conference Center

Oct 28, 2019 7:00 AM - Oct 30, 2019 12:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Oligonucleotide-Based Therapeutics Conference

Breakfast Plenary Session: Global Regulatory

Session Chair(s)

Paul C. Brown, PhD

Paul C. Brown, PhD

Associate Director for Pharmacology and Toxicology, OND, CDER

FDA, United States

Laurence  Whiteley, DVM, PhD

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.


Yoko  Hirabayashi, MD

Draft Guideline for Non-Clinical Safety Evaluation of Oligonucleotide Therapeutics in Japan

Yoko Hirabayashi, MD

National Institute of Health Sciences, Japan

Division Head

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