A
TMF system is more than a living archive of a clinical trial's progress; it is a system required by regulatory authorities and is critical for clinical oversight. By developing, implementing and utilizing a sound
TMF plan, you will be able to monitor a trial as it advances, ensure high-quality documents and prepare your organization for an inspection at any stage. Additionally, by creating a
TMF process, the clinical trial's sponsors, CRO, and site will be able to demonstrate their continued adherence to GCP during the trial.
At the
7th Trial Master File Summit, 40+ speakers will share best practices on a wide range of topics including:
- Quality TMF process improvement
- System migration and eTMF implementation
- Determining and Managing Relevant communications in the TMF process
- Completeness review by the study team and how to streamline this process
- Maintaining a real-time TMF system and implementing processes to maintain a real-time eTMF system
- Senior Management acceptance/funding/championing of eTMF implementation
- Metrics with CRO and internal staff
- How to construct a successful TMF team
- Involving functions in TMF systems
- Relevant correspondence, working with CRO partners, inspection readiness
- Document management and processes
- TMF QC or TMF process implementation
- Inspection readiness, metrics, sponsor oversight responsibilities
- Nothing specific at this time
- CRO's and their SOP's and standards
- Study Close-out/Transfer
- How to set up a successful TMF staff. How to reduce the number of correspondence by downsizing the number of emails
Top Five Reasons to Attend
- Learn from case studies and best practices for designing and implementing a TMF plan for global trials and inspectional readiness
- Networking and learning with over 250 TMF colleagues
- Hear updates on the DIA reference model and MCC's metrics working group
- Develop a TMF strategy to ensure proper TMF oversight
Explore the latest trends, preparations and expectations for TMF inspections from the FDA, EMA, MHRA and PMDA
Speakers
- Sharon Ames, Director, Client Solutions, PHLEXGLOBAL
- Dina Antonacci, Clinical Training and Systems Manager, MALLINCKRODT PHARMACEUTICALS
- Evelin Baez, Clinical Document Management Specialist, CR BARD
- Terri Baker, Director, Professional Services, WINGSPAN TECHNOLOGY
- Brenda Brown, Trial Master File (TMF) Business Support and CAPA Management Lead, PFIZER
- Mark Choe, TMF Quality Management and Inspection Readiness Consultant, DAIICHI SANKYO
- Grace Crawford, VP Clinical Quality and Compliance, MedImmune
- Mike Czaplicki, Clinical Documentation Operations Manager, GSK
- Martina Duevel, Senior Global Clinical Project Manager, BAYER PHARMACEUTICALS
- Sholeh Ehdaivand, President and CEO, LMK CLINICAL RESEARCH CONSULTING
- Catharine Espanhol, LATAM eTMF Coordinator, BOEHRINGER INGELHEIM
- Betsy Fallen, Special Topics Consultant, SAFE-BIOPHARMA ASSOCIATION
- Renee Fate, Director, Clinical Records Management, ALLERGAN
- Janice Fletcher, Senior TMF Project Manager, RHO
- Allison Grosik, Senior Associate, TMF Management and Compliance, EISAI
- Amy Gunnett, Certified Clinical Research Coordinator, UNIVERSITY OF FLORIDA
- Louise Hawkins, Clinical Operations Manager, Clinical Operations, AGIOS PHARMACEUTICALS
- Wendy Kelly, Manager, Global Development, SUNOVION PHARMACEUTICALS
- Aryn Knight, Clinical Research Oversight Specialist,TEXAS HEALTH INSTITUTE
- Amy Lounsbury, Manager, MINN. GASTROENTEROLOGY P.A.
- Joanne Malia, Associate Director, Clinical Documentation Management, REGENERON
- Alex Markiel, Associate Director, Developmental Sciences Quality, BIOMARIN
- Colleen Maude, Director, Trial Master File, MEDIMMUNE
- Jason Methia, VP, Vault Clinical, Enterprise, VEEVA SYSTEMS
- JP Miceli, Associate Director, Clinical Document Management, SHIRE
- Jackie Morrill, Director of Clinical Operations, LMK CLINICAL RESEARCH CONSULTING
- Lisa Mulcahy, Owner and Principal Consultant, MULCAHY CONSULTING
- Laura Naranjo, TMF Operations, Clinical Development Operations Function, DAIICHI SANKYO
- Dawn M. Niccum, Director, Quality Assurance, INSEPTION GROUP
- James Peters, Director of Professional Services, DATA REDUCTION SYSTEMS CORPORATION
- Marie-Christine Poisson-Carvajal, TMF Operations Lead, PFIZER
- Jennifer J. Poulakos, Director, Development Quality Assurance, AGENSYS
- Tyler Prater, Clinical Trial Management, ELI LILLY
- Lori Julia Ridge, Clinical Operations Project Associate/eTMF Analyst, MYLAN
- Kelley Robinson, Repository Management Lead, Content Management and Authoring, PFIZER
- Fabio Rodrigues, Head of eTMF in LATAM, BOEHRINGER INGELHEIM
- Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
- Eric Rubinson, Executive Director, Clinical Records Management, ALLERGAN
- Kate Santoro, Clinical Trial Manager, Clinical Systems and Documentation, ALKERMES
- Supriya Shoroff, Associate Director, TMF, SAGE THERAPEUTICS
- Shannon A. Simpson, IRB and Clinical Trials Documentation Specialist, PATH’S CENTER FOR VACCINE INNOVATION AND ACCESS
- Bryan Souder, Director, TMF Head, MERCK & CO., INC., USA
- Jamie Toth, Head of TMF Operations, DAIICHI SANKYO
- Wendy Trimboli, Head of TMF Process Management and QC, EISAI
- Anne-Mette Varney, Principal Competency Development Specialist, NOVO NORDISK
- Stephanie Viscomi, Associate Director, TMF, Clinical Training and Records Management, IMMUNOGEN
- Jason Weinstein, Business Lead for eTMF, REGENERON
- Michele Weitz, Director, GCP Compliance Operations, CLOVIS ONCOLOGY
- Karen Whitson, Assistant Director, Clinical Documentation Center, ABBVIE
- Steve Whittaker, Executive Director, THE AVOCA QUALITY CONSORTIUM; Senior Consultant, THE AVOCA GROUP
- Alana Wriggins, Head Site Management, North America, Global Site Management Operations, ALLERGAN
Please fill in your name and email to receive the conference agenda of this event.
Pre-Conference TMF Training Day - Tuesday, January 16, 2018
Conference Day One - Wednesday, January 17, 2018
Conference Day Two - Thursday, January 18, 2018
The agenda is available as PDF under downloads at the right side of the page.
Venue
The venue is not yet available for this event.
Follow this event to be informed when the venue is available and stay informed on other changes.
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 and eTMF System Management
- Clinical Document/Data Management
- Clinical Trial Administration
- Clinical Operations
- Regulatory Affairs/Operations
- Trial, Document and Record Management
- Clinical Document Coordination
- Clinical Development/Study Management
- Quality Assurance/Control/Operations
- Competency Development
- Strategic Operations and Planning
- Quality Management
- Informatics
- Clinical IT
This event is also of interest to:
- eTMF Process Service Providers
- Data/Records Management Vendors
- Clinical Research Organizations
- Paper and Electronic Archiving Solution Providers
Venue
Hyatt Regency Grand CypressOne Grand Cypress Blvd.
Orlando, FL 32836
Hyatt Regency Grand Cypress is a family-friendly, luxury resort where elegance and convenience come together. See for yourself with our scheduled shuttle service to area theme parks, outdoor gardens, twelve tennis courts and 45 holes of Jack Nicklaus Signature designed golf. Inside, you’ll find 815 guest rooms, award-winning restaurants and more than 65,000 sq. ft. of meeting, wedding and event space.
To make reservations, guests can call 1-800-233-1234 or 407-239-1234 and request the negotiated rate for ExL’s 7th Trial Master File Summit. To make reservations online
Click HereThe group rate is available until December 26, 2017. Please book your room early, as rooms available at this rate are limited.
