Opportunities lie in enhancing data integrity auditing skills within pharmaceutical manufacturing, focusing on GxP audits. Companies can capitalize by offering comprehensive training that delves into ...

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started a review of Amgen’s Tavneos (avacopan), ...

"EMA will now review all available data to assess whether this emerging information has an impact on the balance of benefits and risks of Tavneos," said the EU regulator. "The agency will then issue a ...

In the latest bunch of recommendations from the European Medicines | Sanofi, Novo Nordisk, UCB and others received positive ...

Validfor is excited to announce the launch of its Agentic Digital Validation Platform for life sciences, designed to ...

Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...

aTyr Pharma's pivotal data readouts in 2025 for SSc-ILD (Phase 2) and pulmonary sarcoidosis (Phase 3) could significantly impact its market potential and approval prospects. Efzofitimod shows promise ...

Data integrity is key to the success of any cell therapy program. CDMOs can implement robust data management systems for ...

At a time when organizations are dedicating vast resources and staff hours to exploring the applications of artificial intelligence in the workplace, data integrity has become a make-or-break factor ...