August 16-17, 2021
Online Livestream
2nd ElectronicTrial Master File Forum
Days
Hours
Minutes
Seconds

Your skills at using integrated TMF technology will make or break the success of your clinical research. A full command of the details is essential – yet the dangers and variables change significantly based on your company’s size and worldwide markets.

DGE’s 2nd eTMF Forum provides unprecedented depth on meeting regulatory requirements, prepping for audits, prioritizing inspection readiness, and novel techniques for tracking and filing correspondence.  Join us on a proven interactive streaming platform August 16-17, for success techniques you won’t find anywhere else!

Top Reasons to Attend
  • Improve your competitive position through enhanced inspection readiness techniques
  • Communicate the expectations and timing of a completeness review
  • Build a robust function quality review process and ensure quality control
  • Refine collaborative procedures with CROs and sites
  • Align with SOP and work instructions among both sponsors and third parties
Who Should Attend
You will benefit from attending this event if you are a Life Science professional working in the medical device, pharmaceutical, biotech, or CRO sectors, with responsibility in the following areas:
  • TMF/eTMF Operations/Management
  • Data Management
  • TMF Lead
  • TMF Project Manager
  • Head of Trial Master File
  • Clinical Document
  • Clinical Research Associate
  • Clinical Trial Coordinator
  • Clinical Team Leader
  • Clinical Project Management
  • Clinical Operations
  • Clinical Trial Assistants
  • Clinical Trial Administration
  • Document and Record Specialist
  • Trial, Document and Record Management
  • Regulatory Operations
  • Regulatory Affairs
  • Clinical Process
  • Strategic Operations
  • Clinical IT
  • Competency Development
  • Quality Control/Operations
  • Quality Assurance
  • Informatics
  • Quality Management
  • Clinical Development/Study Management
  • Clinical Document Coordination

This conference is also of interest to:

  • Solution Providers
  • Paper and Electronic Archiving
  • Clinical Research Organizations
  • DataRecords Management
  • eTMF Service Providers
Event Sponsors
Conference
New Topics
Featured Speakers
Anusha Rameshbabu
TMF Lead
ALEXION
Aryn Knight
Administrative Director - Center for Clinical Research
TEXAS HEART INSTITUTE
Daniel Ansted
TMF Specialist II, TMF Operations Global Clinical Development Operations
SARPETA THERAPEUTICS
Dawn Niccum
Senior Director, Quality Assurance & Compliance
INSEPTION GROUP
Hobson Lopes
Manager, Clinical Archive Management
REGENERON PHARMACEUTICALS
India Gardner
Senior Manager, TMF Operations
ALEXION
Jaime Chang
Manager, Regulatory TMF
BIOGEN
Jason D King-Andreini
Sr Manager, TMF Operations
EIDOS THERAPEUTICS
Jen Horonjeff
Patient Advocate, Founder and CEO
SAVVY COOPERTIVE
Joanne Malia
Director, Clinical Documentation Management
REGENERON PHARMACEUTICALS
Matt Lowery
Director of Clinical Research
SUNCOAST NEUROSCIENCE ASSOCIATES
Rebecca Halbur
Associate Director of TMF Systems
BIOGEN
Ronla Price
TMF Services Lead
ASTRAZENECA
Sholeh Ehdaivand
President and CEO
LMK CLINICAL RESEARCH CONSULTING
Stephanie Viscomi
Associate Director, TMF Operations
ALEXION
Teena Cochran
former Business Improvement Director
GLAXOSMITHKLINE ADVISORY BOARD
Vanessa Suffy
Senior TMF Manager, Clinical Program Operations
REATA PHARMACEUTICALS
Event Schedule
ALL TIMES ARE IN EASTERN STANDARD TIME
Understand how to effectively communicate the expectations and timing of a completeness review. Who should do the review and what are the most important factors they must check?
  • Understand the importance of timing and readability
  • Use technology for maximum integration
  • Explore completeness review from a resourcing and staffing perspective
Sustaining an inspection-ready TMF requires a comprehensive and sound approach, accounting for variables, and evaluating what went wrong. Are you prepared to craft a meaningful response other than having a CAPA to address findings?
  • Build a robust function QC process
  • Link quality management to the TMF Plan, which is a less frequently addressed approach
  • Implement a quality management system in TMF plan documentation for effective change
Patient perspectives collected before, during, and after a trial can help provide a more complete picture about patient priorities, trial outcomes, and the overall trial experience.
  • Identify key topics and methodology for patient insights collection at various trial stages
  • Explore the benefits and limitations of PROs, and how qualitative approaches can provide additional context to outcomes and endpoints
  • Learn the value of exit interviews and how they complement trial data
Develop a working partnership to appreciate the CRO’s experience. While teaching the CRO to understand your end game goals, you need to understand their own requirements and motivations as well.
  • Refine collaborative procedures with CROs
  • Maintain a constant state of inspection readiness while enhancing the relationship with your CRO
  • Establish proper training and support for inspections
Your current portfolio and existent quality review processes need to be evaluated for fit for purpose. This process involves defining your needs, optimal schedule, contributors, and documentation steps.
  • Prepare your teams to evaluate for “Accuracy and Completeness”
  • Track your eTMF improvements over time
  • Ensure quality review documentation
ALL TIMES ARE IN EASTERN STANDARD TIME
By following every update in eTMF reference model activities, you can better adapt to changes in artifact and sub artifacts. Hear about those and other configurations that affect the TMF such as users access, profiles and data dictionaries.
  • Organize eTMF systems with ease
  • Discuss the importance of artifacts/sub-artifacts in eTMF Systems
  • Align additional attribute configuration with your artifacts/sub-artifacts
  • Position assessments through time
Ensure timeliness so that all parties understand their role in the successful documentation of the clinical study. Only rigorous documentation can help preserve reliable data quality.
  • Adapt the eTMF for better clinical data management
  • Implement a stable clinical trial management process with your clinical team and the third-parties
Are you using your eTMF to its full capacity? Probably not. Take an in depth look at the technical improvements that can maximize your eTMF and increase your efficiencies to read data and automatically filing into the eTMF.
  • Align your Index/TOC with your eTMF and discuss the challenges that arise from that reconciliation
  • Work with your technical representative from implementation to maximize your eTMF
  • Hear new and exciting adaptations to your eTMF that most aren’t using or even considering
Effective corroboration with sites is imperative to the success of the TMF. Ensure all correspondence is meaningful and to the point.
  • Incompleteness challenges and solutions addressed regarding sites
  • Certify your sites contact log feature is properly implemented
  • Explore performance and compliance strategies with your site
Register Now

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Event Partners
15
Speakers
21
Days
251
Participants
125
Workshops
90
Venue
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