Fierce TMF Summit Workshop Day

 Workshop A: What You Need to Know About TMF Plan Template Version 2.0!

Presenters:
Jamie Marie Toth, Trial Master File Management & Records, BeiGene USA, Inc.
Deb Oriez, Associate Director, TMF Operations and Inspection Readiness, Sarepta Therapeutics

Description:
The TMF Management Plan has been updated to version 2.0 after 4 years!In this workshop, we will review the constructs of the TMF Plan Template updated by a subgroup of the CDISC TMF Reference Model Working Group and use real examples of how to create your plan for your company.Topics that will be addressed during this workshop are:

• Take a walk-through of the updated TMF Plan Template, reviewing and explaining each component from the beginning, including what was newly added:
  • Re-arranged the order for better flow, i.e. moved Archiving section to section 10 from section 7.
  • Made all definitions as instructional text to be filled in with company-specific definitions.
  • Added tables for both CRO and Sponsor Applicable SOPs.
  • Added table for type of training.
  • Removed the RACI and replaced it with an activity table to state who is doing what.
  • Created a new table for vendor types under TMF format/structure and removed Authoritative Sources as a separate section.
  • Added sub-sections where it made sense to do so.
  • Added TMF Transfer agreement text into section 11.
• Get and generate ideas for quality reviews.
• Best practices from the presenters and the audience.

 Workshop B: Trust the Process: An Overview of End-to-End TMF Management

Presenters:
Gillian Gittens, Director, e-Clinical Strategy & Solutions, TransPerfect Life Sciences
Laurel-Ann Schrader, Director, Client Solutions, TransPerfect Life Sciences

Description:
TMF document management can be a high volume process. If possible, TMF processing should work like a production line with defined workflows, with an organized team and eTMF system functionality and documented audit trails supporting to ensure throughput and quality. In this workshop, you will look at best practice and tips, along with the pitfalls of a smooth TMF processing operation from scan and upload to index, QC and Finalize, through to periodic review.

 Workshop C: The Ugly Truth: A Deep Dive into TMF Review

Presenters:
Jason King-Andreini, Sr Manager, TMF Operations, BridgeBio Therapeutics

Description:
We all face it – do we do enough for quality review, how can it be better, and is it going to be sufficient for inspection readiness? We learn to not trust because no matter how many we perform, Auditors and Inspectors continue to find reasons for us to feel insecure about our quality review process.In this session, we will discuss multiple scenarios for your starting point:

• We have no quality review process implemented
• We have a process, but it isn’t satisfactory
• We want to improve a solid process

Understanding your tools, understanding your systems, and understanding your TMF Contents – creating your relationships for support and subject matter expertise and taking on only what your TMF group can take on but establishing a business case for other functions to participate are THE constant challenges to getting an effective and thorough Quality Review Process established.Join us by bringing your experience, your questions, and your concerns about how to improve a quality review process in your organization.

 Workshop D: Reporting & Archiving: The Overlooked Value of Common eTMF Tasks

Presenters:
Dario Lirio, Senior Director, Clinical Product Management, ArisGlobal
Shannon Kryder, Product Manager, LifeSphere Intelligent Content Management, ArisGlobal

Description:
Day to day eTMF tasks may feel redundant, but they drive important metrics for managing your trials more effectively. Learn about the overlooked value in your common eTMF tasks and how you can use them to your advantage in the future.