Kit C. Roes

Nov 22, 2024 | ascpt.onlinelibrary.wiley.com | Peter Arlett |Kit C. Roes |Luis Correia Pinheiro |Flora Musuamba Tshinanu

The European Medicines Regulatory Network (EMRN) has developed a multi-annual workplan to leverage artificial intelligence (AI) for public and animal health. The plan focuses on regulating products including AI in their lifecycle, enhancing process efficiency, and advancing healthcare data analytics through four streams: guidance and policy, tools and technology, collaboration and change management, and experimentation.

Apr 28, 2023 | onlinelibrary.wiley.com | Manja Deforth |Charlotte Micheloud |Kit C. Roes |Leonhard Held

1 INTRODUCTION There are several ways how a new treatment can obtain market approval by regulatory agencies. Confirmatory clinical evidence for the effectiveness of a drug is usually required, and often includes some evidence of robustness.