3D Tissue Models
7th Trial Master File Summit
Hyatt Regency Grand Cypress
One Grand Cypress Blvd.
Orlando, United States
7th Trial Master File Summit
ExL Event
Hyatt Regency Grand Cypress
One Grand Cypress Blvd.
United States

Schedule of Presentations:

Tuesday, January 16, 2018
07:30:00 Registration and Continental Breakfast Begin
08:00:00 Dinner Workshop Concludes
08:00:00 BUILDING THE FOUNDATION Breakfast Workshop Lisa Mulcahy
11:00:00 Breakfast Workshop Concludes
16:30:00 Seminar Concludes
17:00:00 OUTLINE YOUR MANAGEMENT OF THE TMF Dinner Workshop Lisa Mulcahy
Wednesday, January 17, 2018
08:00:00 Registration and Continental Breakfast Begin
08:45:00 Summit Chairpersons’ Opening Remarks
09:15:00 Case Study Focus on Quality by Conducting a Comprehensive TMF Review
09:45:00 Survey and Comprehend Essential Considerations of Accurate Resourcing for eTMF Janice Fletcher, Sharon Ames
10:15:00 Networking Break
10:45:00 Take a Deep Dive Into Effective TMF Collaboration and Metrics Utilization
11:15:00 Ensure Inspection Readiness From the Beginning
11:45:00 Panel Establish Milestones for Piloting, Implementing and Executing a TMF System Shannon A. Simpson, JP Miceli
12:30:00 Ensure GCP and Harmonization by Bringing Your TMF In-House Sholeh Ehdaivand
13:00:00 Luncheon
14:00:00 Case Study Survey the Triumphs and Challenges of a Large-Scale eTMF Implementation on a Short Timeline Wendy Kelly, Mike Czaplicki
14:35:00 Transition Time
14:40:00 Improve Your TMF Process by Creating a Collaborative Culture That Empowers Teams
15:15:00 Networking Break
15:45:00 Create Effective QC Process for Documents in an Electronic and Paper Formats
16:20:00 Transition Time
16:25:00 Case Study Experience Implementing and Ramping up an eTMF System
17:00:00 Networking Reception
18:00:00 Day One Concludes
Thursday, January 18, 2018
06:00:00 New Presentation
06:00:00 New Presentation
08:00:00 Registration and Continental Breakfast Begin
08:30:00 Co-Chair’s Recap Day One
08:45:00 Use Software Development Methodology to Maintain Quality in Your TMF
09:20:00 Transition Time
09:25:00 Case Study Maintain Consistency Through M&A and Other Transitions
10:00:00 Break
10:30:00 Set up a Successful TMF Staff James Peterson
11:05:00 Transition Time
11:10:00 Panel Coordinate to Collaborate: How CROs and Sites Can Become Partners Colleen Maude
11:45:00 Transition TIme
11:50:00 Build Your Comprehensive TMF Governance Documents Suite Evelin Baez, Melissa Asare-Aboagye
12:25:00 Luncheon
13:15:00 Prepare for a TMF Inspection — Follow the Trends and Remain Compliant
13:45:00 Panel Monitor eTMF Completeness and Compliance Kelley Robinson
14:45:00 Break
15:00:00 Panel Learn From Sites to Inform and Standardize Procedures, Provide Support and Develop Trainings Amy Lounsbury
15:45:00 Panel Coordinate to Collaborate: How CROs and Sites Can Become Partners Colleen Maude
16:30:00 Conference Concludes
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