Breakfast Briefing: Health Sciences Records Archives Association (HSRAA)- Exploring Archiving Considerations & Challenges to Effectively Navigate Shifting Regulations

Time: 8:00 am
day: Day Two


While eTMF systems advance, the maintenance of data integrity and management of long-term records become more complex. With rapidly changing regulations, now is the time to join industry experts, Jamie Toth, Beigene and Hobson Lopes, Regeneron, and dive into an in-depth exploration of what record management and regulatory frameworks are required for long-term archiving to ensure a healthy and compliant eTMF:
• Understanding records management principles to ensure a healthy eTMF
• Outlining regulatory framework for GxP archives to best navigate requirements
• Illuminating key required roles for archiving and document management
• Exploring the GxP archive to understand what it involves
• Navigating the use of third parties