TransPerfect Life Sciences invites you to be a part of the 2025 TMF Education Road Show.
Join us for an afternoon focused on compliance, best practice, and industry trends. We can’t wait to share this experience with you!
April 3rd | 3:00 PM
Cambridge, MA
Agenda
3:00 – 3:30 pm: Welcome
3:30 – 4:15 pm: Workshop #1: 2024 Trends and Building for the Future
Effective Trial Master File (TMF) management is crucial for ensuring compliance, streamlining clinical trial operations, and maintaining inspection readiness. Whether you’re new to TMF or an experienced professional, we have 25 expert strategies to help you optimize your TMF processes and achieve greater efficiency. Let’s focus on five. Ensuring compliance and regulatory readiness, organizing TMF documents efficiently, enhancing operational efficiency, strengthening risk management and quality assurance, and maximizing long-term value of tmf management.
4:15 – 5:00 pm: Workshop #2: Inspection-Readiness Preparation with New Regulations
Overall best practices for inspection readiness with ICH E6(R3) focus on maintaining a culture of compliance, ensuring robust documentation, and implementing risk-based quality management. Some key steps include: proactive preparation, risk-based approach, data integrity and transparency, stakeholder training, and TMF maintenance.
5:00 – 7:00 pm: Happy Hour and Networking
Meet Your Hosts
Laurel-Ann Schrader
Member of the CDISC TMF Reference Model Committee
Jacklen Gillette
Veteran TMF Operations Professional