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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

Session 8 Track C: General CMC Q&A Session

Session Chair(s)

Kim  Tyndall

Kim Tyndall


CMC Tyndall Consultant LLC, United States

During this session, you will have the opportunity to interact with regulators and experts to discuss current and future concerns in the development of oligonucleotide programs. This open discussion will focus on pre-submitted questions and open the floor to questions from the audience. It is your time to explore the oligonucleotide regulatory arena. There will be regulators from FDA, EMA, PMDA, bFarm, and academia.


Kim  Tyndall


Kim Tyndall

CMC Tyndall Consultant LLC, United States


Veronika  Jekerle, PhD, RPh


Veronika Jekerle, PhD, RPh

European Medicines Agency, Netherlands

Head of Pharmaceutical Quality

Hiroshi  Takeda, PhD, MS


Hiroshi Takeda, PhD, MS

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Technical Officer

Ramesh  Raghavachari, PhD


Ramesh Raghavachari, PhD

FDA, United States

Chief, Branch I, DPMA1, OLDP, OPQ, CDER

René  Thürmer, PhD


René Thürmer, PhD

Federal Institute for Drugs and Medical Devices, Germany

Deputy Head of the Unit Pharmaceutical Biotechnology BfArM

Ian  Dobson


Ian Dobson

Health Canada, Canada

Team Leader, Evaluator

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