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DIA/FDA Oligonucleotide-Based Therapeutics Conference


Session 8 Track C: General CMC Q&A Session

Session Chair(s)

Kim  Tyndall

Kim Tyndall

  • CMC Regulatory Consultant
  • 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)

Kim  Tyndall

Speaker

Kim Tyndall

  • CMC Regulatory Consultant
  • CMC Tyndall Consultant LLC, United States
Veronika  Jekerle, PhD, RPh

Panelist

Veronika Jekerle, PhD, RPh

  • Head of Pharmaceutical Quality Office
  • European Medicines Agency, Netherlands
Hiroshi  Takeda, PhD, MS

Panelist

Hiroshi Takeda, PhD, MS

  • Technical Officer
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Ramesh  Raghavachari, PhD

Panelist

Ramesh Raghavachari, PhD

  • Chief, Branch I, DPMA1, OLDP, OPQ, CDER
  • FDA, United States
René  Thürmer, PhD

Panelist

René Thürmer, PhD

  • Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
  • Federal Institute for Drugs and Medical Devices, Germany
Ian  Dobson

Panelist

Ian Dobson

  • Team Leader, Evaluator
  • Health Canada, Canada