Chemistry, Manufacturing and Controls content
The evolving role of the regulatory professional in the age of Artificial Intelligence
This article explores how artificial intelligence can be used across dossier preparation, CMC, clinical development and more.
Empowering digital innovation in CMC: A framework for regulatory readiness and confidence
This article looks at the evolution of CMC and technologies, such as AI, to help with applications, regulatory assessments and more.
Regulatory challenges and key considerations in the development of radiopharmaceuticals
This article looks at CMC, clinical and non-clinical considerations in the development of radiopharmaceuticals.
HM6: How Artificial Intelligence is transforming regulatory approaches towards chemistry, manufacturing and controls (CMC)
This is a report of the HM6 session that took place at this year’s Symposium.
ICH Q1 guideline revisions to promote innovation and enable global patient access to high-quality medicines
This article looks at the new ICH Q1 stability guidance and its various approaches to help promote innovation.
Maximising regulatory success through early EMA engagement in drug development
This article explores the importance of early regulatory engagement with the EMA and some tools, guidance and procedures on offer.
