Electronic Trial Master File Forum
(East Coast)

Achieving Increased Efficiencies with Integrated Technology and eTMF User Engagement

October 19-20, 2020

East Brunswick, NJ

Event Overview

Integrated technology permeates every aspect of pharmaceutical, biotech and medical device clinical trial research. Attendees at this conference and workshop will learn best practices and actionable strategies for evaluating and implementing eTMF systems, engaging eTMF users, improving clinical data management, and achieving cost savings and workflow efficiencies. Faculty will present on eTMF regulatory requirements, eTMF internal audits/quality reviews to enhance inspection readiness, techniques for tracking and filing correspondence, and AI and machine learning. Speakers will address specifics as for small, mid-size and large companies. Take advantage of this opportunity to share best practices and network with thought leaders and decision makers in the life sciences.

Hilton East Brunswick


3 Tower Center Blvd.
East Brunswick, NJ 08816

(732) 828-2000

Hotel Website

About the Chairperson


Dr. Matthew T. Roe has been a faculty member at Duke University School of Medine and the Duke Clinical Research Institute (DCRI) since 1999. As a senior investigator at the DCRI, he has been the principal investigator for numerous phase II-IV cardiovascular clinical trials and is currently a co-principal investigator for the ADAPTABLE trial—the first large-scale pragmatic trials being conducted in the PCORnet network. He has also served in leadership roles for several observational registries focusing upon the treatment and outcomes of patients with cardiovascular disease and has served as the Director of the DCRI Clinical Research Fellowship since 2010.

Featured Speakers


Craig Lipset

Head of Clinical Innovation


Jeff Kingsley

Chief Executive Officer
IACT Health 


Dawn Anderson

Managing Director, Life Sciences Strategy and Operations, R&D Practice


Ross Friedberg

General Counsel & Chief Privacy Officer
Doctor on Demand

Top Reasons to Attend

  1. Discover the latest integrated technologies that professionals in biotech, pharmaceutical and medical device companies and CROs are using with success to manage clinical trial data and quality
  2. Understand eTMF regulatory requirements and set up your eTMF to assure compliance from the first day
  3. Optimize your organization’s eTMF operations and inspection-readiness with tested, proven best practices
  4. Learn from industry pros how to manage organizational culture change, enhance user engagement and lead cross-functional teams around an eTMF
  5. Enhance your professional and personal network with ample opportunities to meet and speak with peers and thought leaders in clinical data management

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 19th, 2020 | Day 1

8:00 AM - 9:00 AM

Registration & Continental Breakfast

9:00 AM - 9:15 AM

Conference Opening Remarks

9:15 AM - 10:00 AM

Paper to Hybrid to eTMF – Best Practices for Selecting, Implementing, Transitioning and Assuring Compliance from Day One

Maha Saad, Ph.D., MBA - Americas Pharmacovigilance Head, Bioresearch Quality and Compliance, Quality Assurance

10:00 AM - 10:45 AM

Moving Toward a Risk-based eTMF Operating Model

Laura Naranjo - Associate Director, TMF Operations

10:45 AM - 11:00 AM

Morning Networking Break

11:00 AM - 12:00 PM

Using Metrics to Optimize Business Decisions


12:00 PM - 1:00 PM

Networking Lunch

1:00 PM - 1:45 PM

Sponsor Opportunity

1:45 PM - 2:45 PM

TMF Inspection Readiness

2:45 PM - 3:00 PM

Afternoon Networking Break

3:00 PM - 4:00 PM

Best Practices for Compliant eTMF Archiving


4:00 PM - 4:45 PM

TMF Governance

4:45 PM - 5:00 PM

Day 1 Closing Remarks


October 20th, 2020 | Day 2

8:00 AM - 9:00 AM

Registration & Continental Breakfast

9:00 AM - 9:15 AM

Recap of Day 1 & Day 2 Opening Remarks

9:15 AM - 10:00 AM

Emerging Technologies: AI for eTMF Quality Review

10:00 AM - 10:45 AM

PANEL: Welcome eTMF! Embracing Technology and Culture Change Management


10:45 AM - 11:00 AM

Morning Networking Break

11:00 AM - 12:00 PM

CASE STUDY: Using Electronic Software Suites to Automate Communication, Streamline Workflow and Increase Efficiency

12:00 PM - 1:00 PM

Networking Lunch

1:00 PM - 1:45 PM

Sponsor Opportunity

1:45 PM - 2:30 PM

CASE STUDY – Mastering the Basics of a Sound eTMF System in a Small Biotech Organization

2:30 PM - 2:45 PM

Afternoon Networking Break

2:45 PM - 3:45 PM

Effective Tracking and Filing of Correspondence

3:45 PM - 4:30 PM

AI, Machine Learning and Digital Tools – Practical Applications in Clinical Operations for Today and Tomorrow

4:30 PM - 4:45 PM

Day 2 Closing Remarks



Oscar Segurado

ASC Therapeutics

Chief Medical Officer


Judy Hsiung

Arena Pharmaceuticals

Vice President Safety & Pharmacovigilance


Israel Gutierrez

Geron Corporation

Vice President, Pharmacovigilance and Drug Safety


Joan A. Chambers

The Center for Information & Study on Clinical Research Participation (CISCRP)

Senior Director, Marketing & Outreach


Michael Forstner


Senior Vice President and Head of Pharmacoepidemiology and Risk Management


Sheila Bose

SB Lifesciences Consulting, Inc



Christine Von Raesfeld

More Than Lupus

Patient Advocate and Board Member


Angela Ramirez Holmes

Cal Rare





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Contact Amy Chapman at (561) 571-7687
or achapman@dgeconfs.com




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