Jan 18, 2024 SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin – Preparation Authorisation under the SoHO Proposal By Marc Martens Lora Arifagic The SoHO proposal introduces the procedure for obtaining an authorisation for SoHO preparations by the introduction of an EU-wide...
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...