Learn New Ways to Optimize TMF Health at Phlexglobal's Complimentary TMF World Forum

 

As regulatory agencies redouble their focus on Trial Master File compliance and the complexity of clinical trials increases, effective TMF management and inspection-readiness is now more critical than ever.

Attend the 2019 Phlexglobal TMF World Forum & User Conference to obtain practical guidance on Trial Master File best practices from leading TMF experts at Phlexglobal as well as companies like yours. You’ll discover how to overcome people, process, and technology challenges to better maintain TMF quality, completeness, and timeliness - with less time and effort.

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.

Registration is complimentary for TMF and Pharmaceutical industry professionals. Plus, Phlexglobal is offering hotel rooms at the low price at $189 a night. Don't delay--secure your space today! 

 

Register Now Reserve a Room

 

The TMF World Forum Agenda - U.S.

DAY 1 - October 8th 
11:45 am Registration and Lunch  
12:45 pm Opening Remarks from the CEO

John McNeil
Chief Executive Officer

1:00 pm 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. 

Marion Mays
Vice President, Expert Services
Phlexglobal 

1:30 pm Elevating the Importance of the TMF in Your Organization
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
Director, Client Solutions
Phlexglobal 

2:15 pm Networking Break  
2:45 pm 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 organization into a TMF pro. 

Sharon Ames
Director, Client Solutions
Phlexglobal 

3:15 pm Business Case: An Exploration of TMF Operational Models
An exploration of functional TMF models and how they can better improve TMF Health

Wendy Beeby
Director, Clinical Document Management and Inspection Readiness
Takeda Pharmaceuticals

Jodi Scarola
Sr. Consultant, Client Solutions
Phlexglobal

4:00 pm Panel Discussion:
Raising TMF Topics in Your Organization
A group of experienced TMF leaders discuss presenting ideas to leadership and getting buy-in from your organisation.
 TBA
4:30 pm The Value of Risk-Based Quality Checks
New regulations are pushing for a risk-based approach to quality in clinical trials. This session will focus on ways to implement this strategy in your organization. 

Sharon Ames
Director, Client Solutions
Phlexglobal 

Eric Day
Senior Consultant Client Solutions
Phlexglobal 

5:45 pm

Cocktail Reception and Dinner

 

   
DAY 2 - October 9th
8:00 am Breakfast  
8:45 am

Opening Remarks

 

9:00 am

How External TMF Support can be the Key to TMF Health
You're not in this alone! Having the right external support can make a world of difference in achieving TMF Health. Learn ways Regeneron has leveraged available resources to better support their TMF management. 

Joanne Malia
Associate Director, Clinical Documentation Management 
Regeneron

9:45 am

A Broader View of Clinical Trial Technology
Increased specialization has made many of us experts in one area but uninformed in others. Join us for an overview of the clinical technology landscape and improve your overall clinical trial knowledge. 

Jim Streeter
Global Vice President Life Sciences Product Strategy
Oracle

Karen Roy
Chief Strategy Officer
Phlexglobal

10:30 am Networking Break  
11:00 am

A Technology approach to Risk-Based Quality Review
Learn more about ways technology like Heatmaps can help you focus your attention and resources on what matters most. 

Sharon Ames
Director, Client Solutions
Phlexglobal 

Aaron Grant
Solutions Consultant
Phlexglobal

11:45 am

eTMF Features to Help Ensure TMF Health
New advances in technology are streamlining the TMF process and helping us all better achieve quality, completeness, and timeliness. In this session, we will explore these advances and how they can benefit your TMF process. 

Aaron Grant
Solutions Consultant
Phlexglobal

12:30 pm

Lunch

 

1:30 pm

TMF Health Zone: The Game
Put your TMF knowledge to the test with the Phlexglobal team.

Marion Mays
Vice President, Expert Services
Phlexglobal 

Chris Englerth
Head, Global Marketing
Phlexglobal

2:15 pm

Clinical Technology Integrations: Why they are Critical to Daily Data Workflows
There's nothing better than identifying the right technology solutions for your organization and finding ways to make them work together. We will look at some of the best ways to build your "dream platform" with best-of-breed technology. 

TBA

3:00 pm

Staying Healthy
Using Metrics, Dashboards, and Reports to keep your TMF inspection ready. 

Marc Webb
Director, Client Solutions
Phlexglobal 

3:30 pm

Final Observations and Meeting Close

 

 

Location: The Beautiful Sonesta Philadelphia Downtown in Rittenhouse Square

Sonesta Rittenhouse

Act now! Rooms available for $189 a night

Chosen for its meeting amenities and centralized location, the Sonesta Philadelphia Downtown is the perfect location for this event. Phlexglobal has secured a limited room block as the special rate of $189 a night. Act now to secure your space! 

Reserve a Room

 

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