Fierce European Trial Master File Summit 2022 has ended

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Fierce European Trial Master File Summit 2022

10:00 GMT

Registration & Welcome Tea

11:00 GMT

Workshop A - How the TMF Professional can “Win Friends and Influence People” to Manage their TMF ContentLisa Mulcahy, B.S. Workshop B – TMF Quality Control: Develop a Risk-Based Approach to TMF Management and OversightSarah Curno

13:00 GMT

Networking Lunch Hyatt Regency Churchill

14:00 GMT

Workshop C: Define and Develop TMF Metrics as Oversight on TMF PerformanceMartin Hausten Workshop D: Align on Differences in the TMF Process When Working with PartnersGillian Gittens • Laurel-Ann Schrader

08:00 GMT

Networking Breakfast & Registration

08:45 GMT

Chairperson’s Opening RemarksVittoria Sparacio • Henry Raley

09:00 GMT

What Changes in ICH E6 R3 Can Be Anticipated in Relation to Impact on Clinical Trial Essential Documents and Trial Master Files and Why?Andrew Fisher, MS

09:30 GMT

Group Discussion on ICH E6 GCP and TMFAndrew Fisher, MS

10:00 GMT

Considerations for a Global TMFLaurel-Ann Schrader • Gillian Gittens

10:30 GMT

Panel: How Trial Teams and Study Monitoring Groups Strive to Maintain ComplianceBarbara Hepworth-Jones • Andrew Fisher, MS • Mallorie Sayre, MSIS • Damien Mair

11:15 GMT

Networking Break

11:45 GMT

Explore Strategies for Maintaining a Contemporaneous TMFChris Jones

12:15 GMT

How Can TMF Management Impact Overall Trial Quality?Eldin Rammell • Rob Jones

12:45 GMT

Networking Lunch

13:45 GMT

From File Cabinet to a Process Hub: The Remarkable Journey of the eTMFKen Lownie

14:15 GMT

Explore Differences in a Sponsor-Managed vs. CRO-Managed eTMFMartina Duevel • Christopher Betts • Stephanie Viscomi • Liz Farrell

15:00 GMT

Networking Break

15:30 GMT

A Look Beyond Document Management: How to Build a Strong TMF Performance Culture?

16:00 GMT

Interactive Discussion: How the TMF Adds Value to Functional AreasMeredith Lafond-Phésans • Ranee DiCarlo

16:45 GMT

Chairperson’s Closing RemarksVittoria Sparacio • Henry Raley

17:00 GMT

Networking Cocktail Reception

18:00 GMT

Conference Day One Concludes

08:00 GMT

Networking Breakfast

09:00 GMT

Chairperson’s Opening RemarksVittoria Sparacio • Henry Raley

09:15 GMT

The Ripple Effect of SaaS eTMF Upgrades: Strategies for Efficient ValidationDarshan Patel

09:45 GMT

The Harmonization of Clinical Research Information Standards: What Will the Future of the TMF Look Like? Presented by the TMF Reference Model and CDISCLisa Mulcahy, B.S. • Rhonda Facile, MS • Joanne Malia • Kathie Clark • Karen Roy

10:45 GMT

Networking Break

11:15 GMT

Streamlining your eTMF: 10 Good Practices for Reducing Both Effort and RiskKathie Clark

11:45 GMT

Incorporate Milestones and Expect Document Lists (EDLs) into Your TMF PracticeSoraya Nossoughi

12:15 GMT

Networking Lunch

13:15 GMT

Explore the Increased Use ‘Merging’ of Data to Enhance Research Data & Improve Patient SafetyMick Mullane

13:45 GMT

Transform Your TMF into an Active Study Management ToolVittoria Sparacio

14:15 GMT

Chairperson’s Closing RemarksVittoria Sparacio • Henry Raley

14:30 GMT

Conference Concludes