3D Tissue Models
7th Trial Master File Summit
Hyatt Regency Grand Cypress
One Grand Cypress Blvd.
Orlando, United States
http://tmfsummit.com/us?utm_source=Evvnt&utm_medium=Post&utm_campaign=C945
7th Trial Master File Summit
ExL Event
http://tmfsummit.com/us?utm_source=Evvnt&utm_medium=Post&utm_campaign=C945
Hyatt Regency Grand Cypress
One Grand Cypress Blvd.
Orlando
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
11:30:00 KEYS FOR SUCCESS: OPERATIONALIZING YOUR TMF Lunch Seminar Lisa Mulcahy
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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