Jan 16, 2024 HMA-EMA publish multi-annual AI workplan: further guidance on the use of AI in the medicines lifecycle By Hester Borgers In December 2023, the joint HMA-EMA Big Data Steering Group (BDSG) published a multi-annual (2023-2028) AI workplan to guide use of AI in...
Sep 14, 2023 EMA’s envisaged risk-based and human-centric approach to regulate AI By Hester Borgers Christian Lindenthal, LL.M. Dr. Nils Lölfing Bird & Bird’s international life sciences and healthcare team is at the forefront of the legal developments with regard to AI and the...
Jun 27, 2023 Proposed reform of the EU pharmaceutical legislation: New regime for orphan medicinal products under the proposed regulation By Anna Koster Hester Borgers Sarah Faircliffe This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
Apr 26, 2023 Single-arm clinical trials: EMA launches consultation By Phillipus Putter In contrast to randomised controlled trials (RCTs), single-arm clinical trials (SATs) are relatively simple by design: a sample of...