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BioTalk

18 Jan, 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...

16 Jan, 2024

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...