Fierce European TMF Summit Workshop Day

 Tuesday, 14 November 2023

What is Workshop Day?

Workshop Day at the Fierce European TMF Summit will take place on Monday, 14 November 2023 and features 3 professional development trainings designed to provide pharmaceutical and biotech professionals responsible for managing TMF and clinical research a deeper, hands-on approach to learning about achieving optimal quality control, ensuring inspection readiness, and streamlining operations and technology.

This is a great opportunity for attendees to learn in a hands-on and interactive setting while being supported by our expert trainers in the room. 

*Workshop Day is available to all-access pass holders

Workshop Day
Workshop Day

Why Attend?

  • Interactive Learning Experience:
    • Engage in dynamic 2-hour sessions designed for active participation, featuring interactive formats that include activities and exercises.
  • Collaborative Strategy Building:
    • Immerse yourself in a collaborative environment where you not only learn but also actively contribute to the creation of actionable strategies.
  • TMF Peer Community Building:
    • Work together to develop tools that will guide your organization's Trial Master File (TMF) towards its full potential, leveraging collective expertise for mutual success.

What Sessions are Available?

Learn the fundamentals to refresh or get an updated perspective on TMF basics; or expand your knowledge further and discover new best practices that will elevate your organization’s TMF operations. Check out the available workshops. Please note: Workshops subjects are subject to change.

  • Workshop A: Develop a TMF Value proposition Statement and Objectives & Key Results (10:00 - 13:00 GMT)
    • ​​​​​Martin Hausten, Boehringer Ingelheim, will be discussing how to create a TMF value map and customer profile, and will help you understand your products/services.
  • Workshop B: TMF Inspection Readiness Essentials: Understanding Expectations, Document Lifecycles, and Reducing Risks (10:00 - 13:00 GMT)
    • Laurel Ann-Schrader and Avani Amin, Transperfect Life Sciences, will discuss regulatory expectations, completeness risks, preparation checklists and more.
  • Workshop C: What Does it Take to Manage a GCP Archive? (14:00 - 17:00 GMT)
    • ​​​​​​​Sarah Hitching, Hedian Records Management, will discuss GCP Archives. This workshop is run by the HSRAA, a global, non-profit, member-driven professional association serving the life sciences/healthcare sectors.