• June 3-6, 2024
  • San Diego Convention Center, California

Sessions

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Regulators & DTRA Enabling DCTs

Thursday, June 06, 2024
Breakout Session
Clinical Trials Innovations
26B
This year, several global regulatory authorities, including the FDA, EMA, and SFDA, have drafted guidance on the design and implementation of Decentralized Trials (DCTs). The Decentralized Trials and Research Alliance (DTRA) and its members have reviewed these guidance documents and have offered comments and input for further consideration and clarification. While there are some differences between the regulatory guidance’s, there are some key themes that session panelists will specifically address. The session will also have leaders from the regulatory authorities further comment on the guidance and the extensive feedback they have received.
Moderator
Amir Kalali, MD
Co Chair
DTRA
Speakers
Jane Myles
Program Director
DTRA
Rasika Kalamegham, PhD
Head US Regulatory Policy
Genentech
Steffen Thirstrup, MD, PhD
Chief Medical Officer
European Medicines Agency (EMA)
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