Role of statistics / quantitative science in regulatory decision-making.Chairs: Emmanuel Zuber (Novartis) and Benjamin Hofner (PEI)
- Talk 1 (15min): Aloka Chakravarty (FDA, virtual): Generating Actionable
Insights Using RWD during COVID-19 pandemic.
- Talk 2 (15min): John Johnston (MHRA): What role should statistics play
in regulatory decision-making?
- Talk 3 (15min): Yuki Ando (PMDA, virtual): Role of biostatisticians in
regulatory decision making: the current discussion in Japan.
- Talk 4 (15min): Rajeshwari Sridhara (FDA, virtual): Experience with the
project SignifiCanT.
- Q&A and panel discussion (30min): Speakers + Kit Roes + Anja Schiel +
Rob Hemmings
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