Electronic Trial Master File Forum

Achieving Increased Efficiencies with Integrated Technology and User Engagement

October 26-27, 2020

Online Livestream

Event Overview

To improve life sciences organization's operations, the quest for reduced cycle times, acceleration, quality, technology is one of the pillars for success. Data and records management is essential to demonstrate integrity, reliability, and compliance. Pharmaceutical companies, CROs, institutions, investigational sites, research centers developing drugs or devices must adapt to a business and regulatory environment that is rapidly changing and evolving. Technical solutions are the new norm and like any other domain records management should adopt electronic solutions for efficient management of the documentation generated during the life cycle of clinical trials.

Attendees at this conference will learn best practices and actionable strategies for evaluating, implementing, and sourcing eTMF systems.  This event will touch upon user engagement, improving clinical data management, and workflow efficiencies. Faculty will present on TMF regulatory requirements, eTMF internal audits/quality reviews to enhance inspection readiness, techniques for tracking and filing correspondence, and AI and machine learning. Take advantage of this opportunity to share best practices with thought leaders in the TMF space.

Top Reasons to Attend

  1. Optimize your organization’s TMF operations and improve inspection-readiness levels with tested, proven best practices
  2. Understand eTMF regulatory requirements and set up your eTMF to assure compliance from the first day
  3. Learn from industry professionals to manage organizational culture change, enhance user engagement, and lead cross-functional teams around an eTMF
  4. Hear eTMF document management strategies directly from leaders in clinical data management
  5. Discover the latest integrated technologies that allow all clinical partners (CRO, sponsor, sites, IRB’s and regulators) secure and global access to dispersed content 

Attendee Profile

This Conference is Designed for Life Science Professionals responsible for:

  • TMF/eTMF Operations/Management
  • eTMF Systems Integration
  • Quality Management Systems
  • Document Management
  • Digital Innovation
  • Clinical/Research Operations
  • Clinical Study Management
  • Clinical Research Management
  • Clinical Trial Compliance
  • Clinical Innovation
  • Clinical Trial Design
  • Clinical Project Management
  • Clinical Regulatory Affairs
  • Clinical Safety
  • Clinical Supply Chain
  • Protocol Design
  • Patient Engagement
  • Patient Experience
  • Patient Recruitment
  • Site Selection & Start Up
  • Investigations
  • Research Nursing
  • Quality Assurance
  • Quality Control
  • Safety Analysis
  • Information Systems Management
  • EClinical Technologies
  • Data Integration/Oversight
  • R & D
  • Risk Management
  • CRO Oversight
  • Outsourcing/Vendor Management
  • Cooperative Research Groups
  • Alliance Management
  • Medical Affairs
  • Medical Information
  • Report Writing
  • Biostatistics
  • Biotech Engineering
  • FDA Submissions
  • Strategic Operations
  • Tactical Planning
  • Corporate Legal Affairs
  • Corporate Financial Planning
  • eTMF Service Providers
  • QMS Service Providers
  • IT Service Providers
  • Clinical Trial Service Providers


October 26th, 2020 | Day 1

8:00 AM - 9:00 AM EST


9:00 AM - 9:15 AM

Conference Opening Remarks

9:15 AM - 10:00 AM

Begin your eTMF Journey with the Most Essential Elements for Success: Processes, Technologies, and People

  • Define end-to-end process and controls using quality by design and risk-based principles
  • From business case to technical solutions and roadmap, identify key steps and components
  • Define TMF operational model, roles and ensure user engagement

Marie-Christine Poisson-Carvajal - Head of TMF and Registry

10:00 AM - 10:45 AM

Create a TMF Plan to Assess, Measure and Align with SOPs

  • Effective revision of your process documents
  • Certify that the SOPs and WIs align
  • Create efficient TMF reference model templates

Traci Wendler - TMF Study Lead Line Head
Bristol Myers Squibb

10:45 AM - 11:00 AM

Morning Break

11:00 AM - 11:45 AM

Execute a Truly Integrated eTMF Process

  • Apply real-time KPIs and metrics to determine the health of your eTMF
  • Generate and manage automated workflow to reduce manual effort and obtain key insights
  • Take advantage of the full capabilities of the platform you adopt

Jason Weintstein - Manager eTMF
Regeneron Pharmaceuticals

11:45 AM - 12:15 PM


12:15 PM - 1:00 PM

Changing TMF Culture from Negative to Positive

  • Change management for long term TMF culture transformation
  • How to achieve a positive TMF culture change with many completing complexities
  • Renew TMF to improve processes

Stephanie Viscomi - Associate Director, TMF Operations

1:00 PM - 1:45 PM

How to Select an eTMF that Works Best for Your Organization's Needs

  • Evaluate and understand the needs to transition to eTMF
  • Define the requirements and controls and articulate the ROI
  • Best practices to prepare for the RFP process

Sholeh Ehdaivand - President and CEO
LMK Clinical Research Consulting

1:45 PM - 2:00 PM


2:00 PM - 2:45 PM

PANEL: Next Generation of eTMFs that are Leveraging Emerging Technologies

  • Grasp practical applications and look ahead to future developments
  • Embrace technologies in the eTMF space
  • How to implement task automation whenever possible 

Keith Win - Business Analyst, TMF Operations
Daiichi Sankyo, Inc. 

Ronla Prince - TMF Services Lead

Paula Carol Federline - TMF Coordinator
Chimerix Inc.

Stephanie Viscomi - Associate Director, TMF Operations

2:45 PM - 3:30 PM

Challenges and Solutions for TMF Completeness

  • Execute truly integrated TMF plan to support your TMF process
  • Generate and manage automated workflow to gain the edge 
  • Ongoing cross checks practices to ensure completeness throughout the TMF

Mary Emanoil - Senior Director, Authoring and Workflow Business Solutions Information Management

3:30 PM - 4:15 PM

Regulatory Improvements for Remote TMF Access for Inspectors and Auditors

  • Identify threats to data integrity and compliance issues
  • Keep Up to Date with EMA and ALCOA Guidelines
  • Strategies to maintain processes in real-time as the TMF is being generated

Jason D King-Andreini - Sr Manager, TMF Operations
Eidos Therapeutics


October 27th, 2020 | Day 2

8:00 AM - 9:00 AM


9:00 AM - 9:45 AM

Collaborate with CROs Using Cooperative Procedures for Highest Productivity

  • Successful strategies to create CRO partnerships that last
  • Build out relationships with internal change management
  • Techniques to develop clear expectations before during and until TMF transfer to the SPonsor

Carolyn DeVivo - eTMF Manager
Xeris Pharmaceuticals, Inc.

9:45 AM - 10:30 AM

Enhance Operational Productivity

  • Optimize your eTMF efficiency 
  • Demonstrate vendor oversight while also undertaking routine system maintenance activities
  • Think ahead: seamless execution of large-scale clinical trials with respect to TMF access and document management

Saurabh Kothari - Director, Regulatory Affairs
Evelo Biosciences

Gordon D. Bedford - Regulatory Documentation Specialist
Evelo Biosciences

10:30 AM - 10:45 AM

Morning Break

10:45 AM - 11:30 AM

Effective TMF Periodic Review Process

  • What is periodic review and why is it important to your TMF
  • When and how is periodic review conducted
  • Periodic review for inspection readiness and archiving

Richard Golden - TMF Analyst
Glaxo SmithKline

11:30 AM - 12:15 PM

Good Documentation Practice to Maintain a Healthy TMF

  • Introduction and Definition of GDP according to ICH guidelines
  • Recognize the importance of methodical and organized documentation in research
  • Some challenges while filing in TMF
  • GDP and maintaining TMF compliant and complete

Christine Beshay - TMF Study Lead, Global Trial Master File Process, Global Clinical Operations
Bristol Myers Squibb

12:15 PM - 12:45 PM


12:45 PM - 1:30 PM

Best Practices for Compliant eTMF Archiving

  • Structure contents for accessibility, storage and quality for successful eTMF archiving
  • Address regulatory challenges facing archiving such as low data integrity, data immutability and retention periods
  • Learn methodologies to digitally preserve and actively manage documents on an ongoing basis

Christopher Michael - GCP Archivist

1:30 PM - 2:15 PM

PANEL: TMF And Being Ready for Next Inspection

  • How to ensure daily processes, procedures, and operations have inspection readiness 
  • Implement proactive versus reactive tactics for inspections
  • Ensuring GCP for the organization’s routine inspections

Ronla Prince - TMF Services Lead

Jason Weintstein - Manager eTMF
Regeneron Pharmaceuticals

Jason D King-Andreini - Sr Manager, TMF Operations
Eidos Therapeutics

Alana Wriggins, BSN, MHS - Assoc. Vice President, Global Site Management Operations, TMF Operations, Compliance & Study Start Up
Formally of Allergan

Marie-Christine Poisson-Carvajal - Head of TMF and Registry



Sholeh Ehdaivand

LMK Clinical Research Consulting

President and CEO


Marie-Christine Poisson-Carvajal


Head of TMF & Registry



Stephanie Viscomi


Associate Director, TMF Operations


Traci Wendler

Bristol Myers Squibb

TMF Study Lead Line Head


Alana Wriggins

Formally of Allergan

Assoc. Vice President, Global Site Management Operations, TMF Operations, Compliance & Study Start Up


Gordon D. Bedford

Evelo Biosciences

Regulatory Documentation Specialist


Saurabh Kothari

Evelo Biosciences

Director, Regulatory Affairs


Ronla Prince,


TMF Services Lead


Christopher Michael


GCP Archivist


Christine Beshay

Bristol Myers Squibb

TMF Study Lead, Global Trial Master File Process, Global Clinical Operations


Mary Emanoil


Senior Director, Authoring and Workflow Business Solutions Information Management


Jason Weintstein

Regeneron Pharmaceuticals

Manager eTMF


Keith Win

Daiichi Sankyo, Inc.

TMF Operations


Carolyn DeVivo

Xeris Pharmaceuticals, Inc.

eTMF Manager


Richard Golden

Glaxo SmithKline

TMF Analyst


Jason D King-Andreini

Eidos Therapeutics

Sr Manager, TMF Operations


Paula Carol Federline

Chimerix Inc.

TMF Coordinator




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