Trial Master File Summit

Effect Inspection Readiness, Quality, and Streamlined Operations Using Technology and Improved Internal and External Alliances

Orlando, FL, United States

A Paragon of Collegial Excellence Wrought by a Participant-Focused Approach

Participants return to work informed, equipped, prepared and inspired to see their TMF to its full potential!

Come and learn from the best with the best!
The collegiality of the speaking faculty is matched by the fellowship among participants. The synergy among the participants that constitute the TMF community at this event is fueled by a shared drive for continuous improvement. This event is truly by, for, and of the participants.

Returning customers are happy customers.
Greater than half of the participants at the 7th TMF Summit had attended at least one of our TMF summits previously. The majority of attendees came as a group.

Bigger is not better - unless it is.

The prominence and annual growth of this event is a testament to the value and impact of the learning, networking, professional development and overall experience to the everyday success of participants.

Continuous Improvement

The 2018 summit featured 40% more sessions and 30% more speakers than 2017. The 8th TMF Summit will continue to expand offerings by adding a third track on day two so that participants may better tailor their experience to their particular needs. Takeaways include:
  • tactics for streamlining operations
  • strategies for collaborating with CROs
  • ideas for embedding inspection readiness
  • tools for plying risk-based QC for data integrity
  • orientation to the future of automation and AI
  • metrics for oversight of trials
  • information on inspection trends
  • lessons learned to support and develop staff

Who Should Attend

This conference is designed for representatives from pharmaceutical, biotech, medical device and clinical research companies with responsibilities in the following areas:
  • TMF/eTMF Systems Management
  • Clinical Document Management
  • Clinical Trial Documentation
  • Clinical Trial Administration
  • Clinical/TMF Project Management
  • Quality Control/Quality Management
  • Clinical Operations
  • Clinical Research Coordination/Management
  • Regulatory Affairs/Operations
  • Trial, Document and Records Management
  • Clinical Document Coordination
  • Clinical Trial Compliance
  • Clinical Development/Study Management
  • Quality Assurance/Control/Operations
  • R&D Quality Management
  • Strategic Operations and Planning
  • Global Development
  • R&D IS Management
This event is also of interest to:
  • eTMF Process Service Providers
  • Data/Records Management Vendors
  • Clinical Research Organizations
  • Paper and Electronic Archiving Solution Providers

"It is great to hear from others that do what I do and understand my concerns and offer solutions. It really helps my confidence that I am doing what is best regarding the TMFs I manage."
Clinical Document Management Specialist, CR BARD

"The event was very informative and will greatly impact current TMF processes in my role."
Clinical Research Support Specialist, NUVENTRA PHARMA SCIENCES

"Enjoyed hearing case studies and implementing an eTMF and leveraging metrics."
Records Analyst, ASTELLAS

Speakers Include

  • Christina Allen, Senior TMF Specialist, TMF Operations, DAIICHI SANKYO
  • Jennifer Arters, eClinical Manager eTMF and Collaboration, CSL BEHRING
  • Evelin Baez, Clinical Document Management Specialist, BECTON DICKINSON
  • Wendy Beeby, Clinical Document Management and Inspection Readiness - SHIRE
  • Kristen Bretzius, Document Center Manager - PSI PHARMA SUPPORT AMERICA
  • Andy Chu, Director, Regulatory Affairs - Regulatory Systems Strategy, BIOGEN
  • Kathie Clark, Vice President, Product Management, WINGSPAN TECHNOLOGY, AN IQVIA COMPANY
  • Grace Crawford, VP Clinical Quality and Compliance, MEDIMMUNE
  • Sheryl Crean, Director Quality Assurance Strategic Advice- Science Unit QA, GCP and PV, ASTRAZENECA
  • Sonja Davis, QA Consultant, QA-Product Research and Development, ELI LILLY
  • Elias Dorfman, Clinical Quality Manager, MERCK
  • Donna Dorozinsky, President, JUST IN TIME GCP
  • Martina Duevel, Systems Excellence Project Leader, BAYER
  • Mary Emanoil, Senior Director, Content Management and Authoring, PFIZER
  • Liz Farrell, Senior Manager, TMF, BIOGEN
  • Paul Fenton, President and CEO, MONTRIUM
  • Karen Freid, Essential Document Specialist, MERCK
  • Patty Fulton, Quality Consultant, TMF, ELI LILLY
  • Susan Groth, Associate Director, Headquarters Clinical Quality Management (HQ CQM) - MERCK
  • Amy Gunnett, Certified Clinical Research Coordinator, UNIVERSITY OF FLORIDA
  • Rebecca Halbur, Senior Manager, TMF Systems, BIOGEN
  • Janis Hall, Senior Consultant, THE AVOCA GROUP
  • Nela Hayes, Senior Manager, Clinical Documentation, ABBVIE
  • Kathy Hijek, Associate Director, Clinical Operations - Duke Clinical Research Institute
  • Victoria Ho, Director, Clinical Operations, GILEAD
  • Michelle Ingraham, Manager information Governance and Compliance - PPD
  • Lisa Joseph, Senior Manager, Process, Training and Compliance, TAKEDA
  • Aryn Knight, Clinical Research Oversight Specialist; Assistant Administrative Director - Center for Clinical Research, TEXAS HEALTH INSTITUTE
  • Amy Lounsbury, Clinical Research Director, MN GASTROENTEROLOGY
  • Joanne S. Malia, Director, Clinical Documentation Management - REGENERON
  • Alex Markiel, Director, Clinical Operations, Head of Clinical Document Control, PHARMACYCLICS
  • Colleen Maude, Director, Trial Master File, MEDIMMUNE
  • Ann McCabe, Director, Process Excellence and Risk Management Clinical Development Operations, DAIICHI SANKYO
  • JP Miceli, Associate Director of Document Management - ADVANCED CLINICAL
  • Pat Miesner, Global Quality Manager - NOVELLA CLINICAL
  • Thomas Miller, Manager, Clinical Supply Planning and Execution, ELI LILLY
  • Lisa Mulcahy, Owner and Principal Consultant, MULCAHY CONSULTING
  • Curran Murphy, Director, Clinical Operations, DECIPHERA PHARMACEUTICALS
  • Elisa Murphy, Senior Information Manager, PFIZER
  • Laura Naranjo, TMF Operations, Clinical Development Operations Function, DAIICHI SANKYO
  • Dawn M. Niccum, Director, Quality Assurance, INSEPTION GROUP
  • Barbara A. Novak, Senior Manager, Clinical Operations, KYOWA KIRIN PHARMACEUTICAL
  • Sabrina Owens, Clinical Trial Administrator - Chiesi
  • Miriam Philmon, Clinical Research Manager, MYLAN
  • Marie-Christine Poisson-Carvajal, Head of TMF Operations, PFIZER
  • Minette Pugh, Advisor, Quality Systems and Compliance Management, ELI LILLY
  • Mark Romano, R&D Customer Success Manager, VEEVA
  • Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
  • Casey Ryan, Clinical Trial Document Specialist, Global Clinical Development, BECTON DICKINSON
  • Barry Sacks, Chief Technology Officer, PHLEXGLOBAL
  • Bryan Souder, Director, TMF Head, MERCK
  • Perry Steinberg, Regulated Content Management, General Manager and Product Leader - MEDIDATA
  • Mindy F. Taback, Clinical Trial Associate, AERIE PHARMACEUTICALS
  • Laura Tenbrink, TMF Manager, XCOVERY
  • Jamie Toth, Director and Head of TMF Operations, DAIICHI SANKYO
  • Melissa Umbehauer Chiasson, Senior Manager, Process, Training and Compliance, TAKEDA
  • Stephanie Viscomi, Associate Director, Clinical Trial Office, IMMUNOGEN
  • Jason Weinstein, Business Lead for eTMF, REGENERON
  • Michele Weitz, Senior Director GCP, Compliance Operations, CLOVIS ONCOLOGY
  • Debra Wells, Manager, TMF and Compliance, EISAI
  • Karen Whitson, Assistant Director, Clinical Documentation Center, ABBVIE
  • Robert Willis, Merck Research Labs IT, Merck
  • Alana Wriggins, Head Site Management, NA, Acquisition Integration and Clinical Records Management, ALLERGAN
Pre-Conference Training Day - January 22, 2019

Conference Day One - January 23, 2019

Conference Day Two
- January 24, 2019


Hilton Orlando Lake Buena Vista
1751 Hotel Plaza Blvd
Lake Buena Vista, FL 32830

Experience a relaxing retreat within walking distance to Disney Springs. Our resort features shuttle service to Disney Theme Parks and Disney Springs, delectable dining options, two heated outdoor pools, an arcade and Disney Character Breakfast on Sundays at Covington Mill.

To make reservations, guests can call 1-800-782-4414 and request the negotiated rate for ExL's January Meetings. To make reservations online Click Here

The group rate is available until January 3, 2019. Please book your room early, as rooms available at this rate are limited.
14 MAY 15 MAY
San Francisco (Burlingame), CA
United States
Event details
Organizer : ExL Events
Venue : Hilton Orlando Lake Buena Vista, Orlando, FL, United States
Event type : Conference
Reference : ASDE-19064