You are invited to a multi-stakeholder workshop where participants will discuss requirements for Digital Health Technologies in clinical trials, including the development of digital endpoints. What are current challenges related to the use of Digital Health Technologies and what the opportunities for optimising evidence generation for qualification and regulatory pathways?
Building on the great momentum in Europe, with initiatives such as ACT-EU or the EMA Regulatory Science Research needs, and advances in IMI projects such as IDEA-FAST or Mobilise-D, EFPIA is organising a multi-stakeholder workshop on the use of Digital Health Technologies (DHTs) in drug development, with a focus on digital data including digital endpoints. This workshop will offer an opportunity to discuss how to optimise DHTs development, evidence generation for validation/qualification, and regulatory pathways, and to clarify some of the challenges faced so far.
To be held virtually on 12-13 December 2022, the workshop seeks to build a roadmap for enabling the use of DHTs in drug development in Europe and beyond. It will be designed with plenary sessions and interactive breakout sessions to integrate views and expectations of the various stakeholders, and to share learnings and solutions.
Discover the draft agenda here.