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
Sarepta Theraputics
India Gardner
Senior Manager, TMF Operations
Alexion
Jamie Chang
Manager, Regulatory TMF
Biogen
Jason D King-Andreini
Sr Manager, TMF Operations
Eidos Therapeutics
Jen Horonjeff
Patient Advocate, Founder and CEO
SAVVY COOPERTIVE
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
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
Investigator and sponsor TMFs must integrate to form the story of the study while protecting patient privacy. Hear about the common elements for both the investigator and the sponsor TMF.
  • Discuss successful methods for enforcing responsibilities and changes
  • Ensure standardization of the investigator TMF records with the sponsor and the reference model
  • Rethink the electronic investigator reference model
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
A revision of ICH GCP guidance is now in progress, and you can’t afford to be left behind. By following every update in eTMF reference model activities, you can better adapt to changes in artifact level and data exchange.
  • Use the artifact level now available in the eTMF industry reference model
  • Discuss the benefits and challenges with this extensive change in your eTMF
  • Align with SOP and work instructions among both sponsors and 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.
  • Hear new and exciting adaptations to your eTMF that most aren’t using or even considering
  • Identify improvements that are configured from user needs
  • Work with your technical representative from implementation to maximize your eTMF
  • Improve configuration changes based on network function feedback
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
TMF Head On ICH, FDA 21 CFR Part 11 as well as other vital TMF regulations will be covered in this session. COVID has changed regulatory visits, understand the accessibility of inspectors and auditors while preserving confidential information of the sponsor (such as contractor agreements).
  • Build an effective virtual team and tackle the challenges that hit because of the pandemic
  • Understand good clinical practices GCP’s
  • Implement techniques to keep your TMF up to date and collect data in real time
eTMF software is rapidly diversifying and increasing uptake around the world. Hear what is working and what is not from KOLs in the industry.
  • Outline common pitfalls from regulatory authorities
  • Gather considerations from strategic partners
  • Explore worldwide eTMF rollouts and troubleshooting
Register Now

This window is secured by 256 bit encryption on a PCI compliant network. Click here to view this window in its own page.

Subscribe to Conference Updates
Join our e-newsletter list to follow closely all news.
Event Partners
15
Speakers
21
Days
251
Participants
125
Workshops
90
Venue
Contact Us