Introduction to the 2nd Edition of the GAMP GPG on GCP Systems
Complimentary
Learning Level: Advanced
Time: 1000 - 1100 EST
Session Length: 1 hour
The pharmaceutical and life sciences industries are navigating an era of rapid technological advancement, heightened regulatory scrutiny, and growing complexities in clinical trials. The GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice (2nd Edition) provides critical guidance tailored to the unique demands of highly outsourced GCP (Good Clinical Practice) environments. This webinar will offer an essential overview of the updated guide, highlighting its practical application in ensuring compliant, efficient, and effective computerized systems in clinical research.
Learning Objectives
- Why GCP is Unique Among GxP Areas: Explore the distinct challenges of GCP environments, where the primary focus is on safeguarding patient rights, safety, and well-being, while ensuring data integrity and the reliability of clinical trial results.
- Emerging Technologies in Clinical Trials: Understand the opportunities and challenges posed by artificial intelligence, real-world data, and decentralized trials in the context of computerized systems.
- Data Integrity and Privacy: Understand the importance of robust data management practices, anonymization techniques, and security measures to meet regulatory expectations.
