New International Signal Detection Initiative To ‘Influence Industry Practice'
Executive Summary
Drug companies, regulators and academia have joined together under a three-year international project to explore what new methodologies should be developed to make the most of the opportunities provided by big data and artificial intelligence in detecting adverse effects of authorized medicines.
You may also be interested in...
EU Group Facilitates Switching Multinational Trials To CTR
Revisions to the updated EU guideline on transitioning multinational trials to the Clinical Trials Regulation are said to be “solution oriented.”
EMA Addresses Rapid Acting Therapies, Psychedelics In Updated Guidance On Depression Treatments
The European Medicines Agency is consulting on major changes to its decade-old guidance on the development of medicinal products for acute and long-term treatment of major depressive disorder.
UK MHRA Gets A Grip On Spiralling Clinical Trial Assessment Timelines
The UK medicines regulator says the loss of experienced staff and the need to recruit and train new assessors resulted in temporary delays to clinical trial applications, but the crisis measures it put in place to address the situation mean it has now turned the corner.