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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
CMC Tyndall Consultant LLC, United States
President
Panelist
Veronika Jekerle, PhD, RPh
European Medicines Agency, Netherlands
Head of Pharmaceutical Quality
Panelist
Hiroshi Takeda, PhD, MS
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Technical Officer
Panelist
Ramesh Raghavachari, PhD
FDA, United States
Chief, Branch I, DPMA1, OLDP, OPQ, CDER
Panelist
René Thürmer, PhD
Federal Institute for Drugs and Medical Devices, Germany
Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
Panelist
Ian Dobson
Health Canada, Canada
Team Leader, Evaluator