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Chris Dai

Device and Combination Products Regulatory Affairs Takeda

Takeda Head of Device of China CMC Regulatory Affairs. Engaged in medical product regulatory affairs for 20 years, focusing on medical devices (active devices, disposable devices implantable devices), drug-device combination products and digital products. Has ever lead Device Regulatory teams in China for Philips and Bayer before Takeda. expertise in submission strategy and project management, regulatory policy research, and regulatory authority communication.

See Chris Dai at this event

  • Day 3 Thursday 5 December

Combining strengths: Preparing regulatory systems for combination products for advanced therapies and biologics

Session objectives:

  • Raise awareness on the current global regulatory landscape on ATMPs and Drug-Devices combination products (DDCPs).
  • Share regulatory best practices and challenges in the APEC region.
  • Discuss the need for capacity-building activities on ATMPs and DDCPs.
  • Discuss the opportunity to develop for the APEC region a cooperative network of experts and an effective roadmap for a combined approach for ATMPs and DDCPs.

Speakers