EMA Guidelines on Computerised Systems: Expert Panel Discussion on Data Integrity and Long-Term Retention in Clinical Trials
Join expert panellists Russell Joyce (Heath Barrowcliff Consulting) and Matthew Addis (CTO of Arkivum) as we dive into the recently published EMA guidelines on computerised systems and electronic data in clinical trials.
This discussion explores the critical aspects of data integrity and long-term retention outlined in the guidelines, shedding light on the potential challenges and opportunities that lie ahead for pharmaceutical companies and sponsors.
Topics also included:
- Exploring the impact of provisions concerning validation
- Potential complexities around proportionality regarding risk
- Data integrity and ALCOA++ for long-term retention
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