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

Sign up now to attend the TMF OOO Day!

Purpose

Training and education regarding TMF best practice for clinical groups, in light of 2023 MHRA Expectations.

Location

Andaz London Liverpool Street (Hyatt)

40 Liverpool Street,

London, England, United Kingdom, EC2M 7QN



Agenda

Short interactive sessions led by Gill Gittens (of Trial Interactive, the TMF Reference Model, now CDISC) accompanied by Avani Amin, TMF Study Owner veteran and Associate Director of Client Solutions will begin at 9:30 AM. These will focus on team training, engagement, and improving TMF best practice as the landscape evolves in 2023. Roundtables and workshops will let attendees learn from and engage with the wider TMF Community.

• 9:30-9:40 AM - Opening Remarks
• 9:40-10:40 AM - EU CTR and the TMF
• 10:40-11:30 AM - TMF Reference Model as a standard
• 11:30-11:45 AM Break
• 11:45-12:30 PM - TMF Management
• 12:30-1:30 PM - Lunch
• 1:30-2:30 PM - Inspection War Stories
• 2:30-3:15 PM - Required/Essential documents for TMF health
• 3:15-3:30 - Break
• 3:30-4:15 PM - eTMF and other eClinical systems
• 4:15-4:30 PM - AOB/Closing Remarks

The sessions will end at 4:30 PM followed by a cocktail hour.

Why you should attend

Attendees will gain insight on how to update and improve TMF strategies based on industry veteran recommendation, and the knowledge and approach of peers. It will also help ensure a more robust plan for TMF Compliance, while learning about new approaches and services to stay inspection ready.