The TMF OOO (Operation, Ownership, and Oversight) Day

Sign up now to attend TMF OOO Day 2024

Overview

By Invitation only, the annual TMF OOO Dat sees 60+ Pharmaceutical firms gather to share, discuss, and learn from challenges in the world of the Trial Master File over the last 12 months. Led by Gillians Gittens and Laurel-Ann Schrader (of the TMF Reference/CDISC committee), we will discuss how to adapt to the latest MHRA instructions pertaining to the TMF. The sessions will have a key focus on training and education, where a range of sponsors (and CROs!) can learn from each other, and help expand and connect the UK TMF community.

Location and Date

MAY 2, 2024

The BREWERY, 52 Chiswell St, London EC1Y 4SA

Tubes/Railway

BARBICAN STATION (5 minute walk)

MOORGATE STATION (5 minute walk)

FARRINGDON (10 minute walk)

BANK STATION (15 minute walk)

LIVERPOOL STREET STATION (15 minute walk)



Agenda

Key topics and panels will include:

• Industry update: E6 R3, M11 and the TMF
• TMF Culture: building for success
• Beyond the TMF; standards for SOPs, Training, Migrations, and Reporting
• TMF Rescues: Responsibilities and approaches for ensuring compliance with an inherited TMF (Mergers and Acquisitions, Team Changes, CRO Transfers and similar)
• Panel: “Bring your problems” – Q and A session with a range of industry veterans to share and discuss specific challenges

Why you should attend

A problem shared is a problem halved: This attendees led event grants insight into how the wider community approaches TMF management, and will help you learn how best update and improve TMF strategies in 2024 and beyond. Based on industry veteran recommendation, and the knowledge and approach of peers we aim to help ensure a more robust plan for TMF Compliance for all attendees, whilst connecting the community, and ultimately, helping peers to remain inspection ready.