Phlexglobal and industry TMF experts will be reviewing the core principles and best practices required to achieve ongoing inspection-readiness for your Trial Master File - the "TMF Health Zone" - along with common challenges companies face in getting there. We'll provide key ways, with actual customer use cases, of how we've been able to help companies like yours reach the TMF Health Zone and stay there!
Each day will feature a series of presentations and panel discussions focused on achieving a balance between people, process, and technology to better to achieve TMF Health. The agenda will feature members of the Phlexglobal Expert Services team (some of the leading authorities in TMF management) as well as TMF experts from leading pharmaceutical companies providing their insight.
Day one will focus on processes necessary to manage TMF health. Day two will cover innovative technological approaches to achieve TMF objectives. Both days will be exciting, interactive, and informative.
Registration is complimentary for TMF and Pharmaceutical industry professionals.
| DAY 1 - 12 November | ||
| 8:45 am | Registration and Networking Breakfast |
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| 9:15 am | Opening Remarks from the CEO |
John McNeil |
| 9:30 am | How to Approach Getting to the TMF Health Zone A practical overview of how People, Processes, and Technology must be balanced to achieve TMF health. |
Eldin Rammell |
| 10:15 am | Elevating the Importance of the TMF in Your Organisation As a TMF professional, you know the value keeping your organization inspection ready. Learn strategies to help key stakeholders and functional document owners understand the importance as well. |
Marc Webb |
| 11:00 am | Networking Break | |
| 11:30 am | The Right Kind of Training TMF owners often cite People and Processes as major challenges in achieving TMF health. But with proper training, you can turn every member of your organisation into a TMF pro. |
Marion Mays |
| 12:15 pm | Lunch |
|
| 1:15 pm |
Panel Discussion: Raising TMF Topics in Your Organisation |
Moderator: Karen Roy Catherine Copse Gergana Koutsarova Ilaria Manzari Angela Ruck |
| 2:00 pm | Business Case: An Exploration of TMF Operational Models |
Marion Mays Jackie Petty Trio Gregory |
| 2:45 pm | Networking Break |
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| 3:15 pm | Getting Functional Support for the TMF Review One of the biggest challenges in TMF management is getting the various functional teams to support your processes. Learn new ways to get your teams in line by collaborating with allies like QA. |
Karen Roy |
| 4:00 pm |
TMF Expert Round Table |
The Phlexglobal Team |
| 5:30 pm |
Cocktail Reception and Dinner |
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| DAY 2 - 13 November | ||
| 8:45 am | Registration and Networking Breakfast | |
| 9:15 am |
A Broader View of Clinical Trial Technology |
Alison Shurell Karen Roy |
| 10:00 am |
An Exploration eTMF's Future |
Moderator: Karen Roy Tom Underhill Aaron Grant |
| 10:30 am |
Networking Break |
|
| 11:00 am |
Staying Healthy |
Marc Webb |
| 11:45 am |
Leveraging Reporting to Better Understand TMF Health |
Rob Jones Eldin Rammell |
| 12:30 pm |
Lunch |
|
| 1:30 pm |
Intelligent Risk Based Quality Review using Heatmaps |
Sarah Curno |
| 2:15 pm |
Top Trends in TMF Data: Real Insights from Real TMFs |
Dinos Hadjicostas Karen Roy |
| 3:30 pm | TMF Health Zone: The Game Put your TMF knowledge to the test with the Phlexglobal team. |
Marion Mays Chris Englerth |
| 4:30 pm |
Final Observations and Meeting Close |
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The Crowne Plaza Gerrards Cross offers a centralized location, fantastic food and ideal amenities. Make the most of your time at the TMF World Forum by reserving a room and joining your fellow attendees for a cocktail reception and dinner at this award-winner hotel and conference center.
