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Bethesda North Marriott Hotel and Conference Center

2017 年 10 月 25 日 7:00 上午 - 2017 年 10 月 27 日 3:00 下午

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

DIA/FDA Oligonucleotide-Based Therapeutics Conference

Convening industry and health authorities to inform, educate, and share advancements in oligonucleotide-based therapeutic product development.

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Session 9A: Interactive Discussion of CMC Challenges and Moving Forward

Session Chair(s)

Kim Tyndall

Kim Tyndall

President

CMC Tyndall Consultant LLC, United States

During this session you will have the opportunity to interact with panelists to discuss current and future concerns in the development of oligonucleotide programs. This open discussion will focus on a set of questions and topics that have been predetermined prior to the conference and will include examples from case-studies as well as complications faced by regulators.

Speaker(s)

Ramesh Raghavachari, PhD

Panelist

Ramesh Raghavachari, PhD

FDA, United States

Supervisor, Unit 3/DPQA IV/OPQA I/OPQ/CDER

Ashley Boam, MS

Panelist

Ashley Boam, MS

FDA, United States

Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER

René Thürmer, PhD

Panelist

René Thürmer, PhD

Federal Institute for Drugs and Medical Devices, Germany

Quality Assessor