Posts with tag EMA

Sort by Latest
HMA-EMA publish multi-annual AI workplan: further guidance on the use of AI in the medicines lifecycle
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 medicines development. The HMA and EMA recognize that pharmaceutical companies are increasingly using AI-powered tools in research, development and monitoring medicines. In this workplan it is stated that the aim is to embrace the opportunities of AI for personal productivity, automating processes and systems, increasing insights into data and supporting more robust...
January 16, 2024
4 min read
EMA’s envisaged risk-based and human-centric...
Bird & Bird’s international life sciences and healthcare...
September 14, 2023
6 min read
Proposed reform of the EU pharmaceutical legislation:...
This article is part of a series that covers the proposed...
June 27, 2023
4 min read
Single-arm clinical trials: EMA launches consultat...
In contrast to randomised controlled trials (RCTs), single-arm...
April 26, 2023
2 min read