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Session 8 Track C: General CMC Q&A Session
Session Chair(s)
Kim Tyndall
President, 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.
Speaker(s)
Speaker
Kim Tyndall
President, CMC Tyndall Consultant LLC, United States
Panelist
Veronika Jekerle, PhD, RPh
Head of Pharmaceutical Quality, European Medicines Agency, Netherlands
Panelist
Hiroshi Takeda, PhD, MS
Technical Officer, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Panelist
Ramesh Raghavachari, PhD
Supervisor, Unit 3/DPQA IV/OPQA I/OPQ/CDER, FDA, United States
Panelist
René Thürmer
Deputy Head of the Unit Pharmaceutical Biotechnology BfArM, Federal Institute for Drugs and Medical Devices, Germany
Panelist
Ian Dobson
Team Leader, Evaluator, Health Canada, Canada
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