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 | 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 |
| 10:00 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. |
Karen Roy |
| 10:45 am | Networking Break | |
| 11:15 am | The Right Kind of Training TMF owners often site 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 |
| 12:00 pm | Business Case: An Exploration of TMF Operational Models An exploration of functional TMF TMF models implemented / presented to leadership. |
Eldin Rammell Director, Expert Services Phlexglobal |
| 12:45 pm | Lunch | |
| 1:45 pm | Panel Discussion: Raising TMF Topics in Your Organisation A group of experienced TMF leaders discuss presenting ideas to leadership and getting buy-in from your organisation. |
TBA |
| 2:30 pm | The Value of Risk-Based Quality Checks New regulations are and pushing for a risk-based approach to quality in clinical trials. Learn ways to bring implement this in your organisation. |
Claire Mooney Sarah Curno |
| 3:15 pm | Ask the Experts: Any TMF Question you have, we will answer! |
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 |
Amplifying Solutions with Automation Technology Augmented Intelligence (A.I.) is an alternative conceptualization of artificial intelligence that focuses on AI's assistive role in advancing human capabilities. We will learn how this can be applied to common clinical and regulatory technologies to amplify their potential. |
TBA |
| 10:00 am |
A Broader View of Clinical Trial Technology |
Jim Streeter |
| 10:45 am | Networking Break | |
| 11:15 am |
A Technology approach to Risk-Based Quality Review |
Karen Roy
Robert Jones |
| 12:00 pm |
Clinical Technology Integrations: Why they are Critical to Daily Data Workflows |
TBA |
| 12:45 pm |
Lunch |
|
| 1:00 pm |
TMF Health Zone: The Game |
Marion Mays Chris Englerth |
| 2:30 pm |
eTMF Features to Help Ensure TMF Health |
Robert Jones |
| 3:30 pm |
Staying Healthy |
Marc Webb |
| 4:15 pm |
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.
