7:45 am Breakfast Briefing Registration

8:00 am Breakfast Briefing: Health Sciences Records Archives Association (HSRAA)- Exploring Archiving Considerations & Challenges to Effectively Navigate Shifting Regulations

Synopsis

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

11:00 am Morning Refreshments & Conference Registration

11:30 am Chairpeople’s Opening Remarks

Navigating TMF Quality & Health Metrics to Establish Industry Standards

11:40 am Exploring How eTMF Health Metrics Can be Used to Improve eTMF Compliance

  • Jason Weinstein Senior Manager TMF Systems & Partner Management, Regeneron

Synopsis

  • Determining how to create eTMF health metrics to leverage the use of your eTMF system
  • Navigating what data is most import for eTMF health metrics to uncover how you improve your tracking
  • Getting study teams to use eTMF health metrics by understanding what drives each team

12:10 pm Panel Discussion: How can Intelligent & Accurate Metrics be Defined to Ensure Compliance

  • Jason Weinstein Senior Manager TMF Systems & Partner Management, Regeneron
  • Keith Win Manager, Clinical Systems, Daiichi Sankyo
  • Nisi Nazim Senior Manager, Global Clinical Operations, BeiGene

Synopsis

  • Discussing the challenges surrounding current metrics definitions to understand how they can be addressed
  • Determining what steps need to be taken to standardize industry metrics such as timeliness and completeness

12:40 pm Fireside Discussion: Understanding How to Manage Sponsor Oversight in a Multi-vendor Ecosystem to Ensure eTMF Compliance

Synopsis

  • Exploring how sponsors oversee eTMF health when there is a multi-vendor environment within CROs
  • Understanding what impact sponsor oversight quality has on data integrity and inspection readiness

Preserving Data Integrity to Ensure Consistent Quality Data

1:10 pm Lunch

2:00 pm Understanding Your Responsibilities for Long-Term eTMF Archiving to Remain Compliant

Synopsis

  • Exploring why data integrity matters for Trial Master Files
  • Navigating what practices and standards can help ensure data integrity over the long-term and during migration into eTMF archives
  • Establishing what level of long-term digital preservation best suits your organization to ensure an effective archive

2:30 pm Roundtables

Synopsis

Delve into discussions on your topic of choice and have the chance to raise your burning questions and talk in more detail about points mentioned during talks:

  • Bots & Artificial Intelligence
  • Working with Sites
  • eTMF / CTMS Integration
  • Inspection Readiness

3:15 pm Navigating Effective Migration of Data Between eTMF Systems to Ensure Data Integrity

  • Keith Win Manager, Clinical Systems, Daiichi Sankyo

Synopsis

  • Understanding the contractual obligation for migration of data at the end of the study to ensure you are compliant
  • Exploring how to implement checksum programs to check data integrity prior to migrations
  • Utilizing a validated & secured staging environment in data migrations

3:45 pm Chairpeoples’s closing remarks

4:00 pm End of Conference Day Two