$1,985 – $8,385

The 7th Trial Master File Summit (EXL)

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Location

Hyatt Regency Grand Cypress

1 Grand Cypress Boulevard

Orlando, FL 32836

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No Refunds

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Event description

Description

A TMF 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 improvement
  • System migration and eTMF implementation.
  • Determining and Managing Relevant communications in the TMF.
  • Completeness review by the study team and how to streamline this process.
  • Maintaining a real time TMF/Implementing Processes to maintain a real time eTMF.
  • 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.
  • 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

  1. Learn from case studies and best practices for designing and implementing a TMF plan for global trials and inspectional readiness.
  2. Networking and learn with over 250 TMF colleagues.
  3. Hear updates on the DIA reference model and MCC’s metrics working group.
  4. Develop a TMF strategy to ensure proper TMF oversight.
  5. Explore the latest trends, preparations and expectations for TMF inspections from the FDA, EMA, MHRA and PMDA.

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 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 Service Providers
  • Data/Records Management Vendors
  • Clinical Research Organizations
  • Paper and Electronic Archiving Solution Providers

Some of the topics under consideration include:

  • TMF QC or TMF Process Implementation
  • Maintaining a real time TMF/Implementing Processes to maintain a real time eTMF
  • Clarity on retention of documents, especially a wet-ink signature documents after file in eTMF
  • Implementing metrics/ risk based metrics and how a external stakeholders can assist this progress
  • Continual progression of the TMF process post eTMF implementation
  • Designing and implementing a TMF governance plan for your CRO and eTMF vendors
  • CRO partnership for TMF
  • TMF inspection readiness action plans


Sponsor


DRS Corp


DRS Corp

DRS Corp is a technology and services company focused on eTMF solutions and TMF services for over 30 years. DRS’ TMF OneSource offers customers a variety of 21CFR Part 11 proprietary hosted validated eTMF solutions, document processing, TMF audit, platform migration and oversight services. DRS’ strategy is to have your TMF audit- and inspection-ready 24/7. DRS carries out business globally with sponsors and CROs from its headquarters in New Jersey.

LMK Clinical Research


LMK Clinical Research

LMK Clinical Research Consulting, LLC, (LMK) is a global Functional Service Provider of Trial Master File (TMF) consulting and TMF services. LMK specializes in the strategic development, project management and quality control of documents and content that support clinical development. A combination of TMF expertise and an extensive knowledge of the clinical drug development process have helped LMK become a trusted leader in the life sciences industry with a reputation for quality.

Phlexglobal


Phlexglobal

Phlexglobal are the Trial Master File (TMF) experts, and pioneers in the provision of innovative, flexible and technology-enabled TMF solutions and services.

A specialist provider of electronic Trial Master File (eTMF) solutions and other support services to the global clinical research market, we offer a unique combination of technology, quality and services that deliver a range of flexible, targeted solutions to the life science industry.

Veeva Systems


Veeva Systems

Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 200 customers ranging from the world's largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America. For more information, visit www.veeva.com.

Wingspan Technology, Inc.


Wingspan Technology, Inc.

Wingspan Technology, a QuintilesIMS company, provides an ECM platform for the life sciences industry in a high-performance, scalable, validated cloud environment. Our industry-leading eTMF is used by sponsors and CROs of all sizes to manage trials from planning through archival. Wingspan eTMF provides the transparency needed to understand TMF health and inspection readiness, along with tools to support and measure the productivity of eTMF processes. As a result, eTMF contributed significantly to supporting our clients’ record of successful health authority inspections.

Event Partners



MEDtube.net


MEDtube.net

MEDtube is an innovative video education platform for health professionals. It allows sharing videos and other materials with a community of more than 110,000 users worldwide, as well as building e-learning courses. The videoteque is updated daily and now contains almost 15 thousand videos.

Pharmaphorum


Pharmaphorum

Pharmaphorum is the exciting new online discussion and networking site for the pharma, medical devices and diagnostics industry. It features topical articles by industry thought leaders upon which users can comment, a live forum for open discussion across various commercial and R&D areas, and a directory of conferences and companies. Aimed at those working in the industry or associated services sector, pharmaphorum welcomes all those involved in bringing healthcare to market who wish to share opinions and ideas in order to drive innovation and progression. Visit pharmaphorum today to share, discuss and debate.

PharmaVoice


PharmaVoice

PharmaVOICE magazine reaches more than 41,000 qualified subscribers and 100,000 users with its digital edition. PharmaVOICE is the forum that allows business leaders to engage in a candid dialogue on the challenges and trends impacting the industry. PharmaVOICE provides readers with insightful and thought-provoking commentary in a multiple-perspective format through forums, topics and articles covering a range of issues from molecule through market. PharmaVOICE subscribers are also kept abreast of the latest trends and information through additional media resources, including Social Media, WebLinx Interactive WebSeminars, Podcasts, Videocasts, White Papers, E-Surveys and e-Alerts.


PM360


PM360

PM360 is the premier, must-read magazine for marketing decision-makers in the pharmaceutical, biotech and medical device industries. Published monthly, PM360 is the only journal that focuses on delivering the full spectrum of practical information necessary for product managers and pharma marketing professionals to succeed in the complex and highly regulated healthcare environment. The journal's targeted and insightful editorial focuses on issues that directly impact critical decision-making, including the planning and implementation of cutting-edge strategies, trends, the latest technological advances, branding/marketing, advertising/promotion, patient/professional education, sales, market research, PR and leadership. Additionally, the "360" in our title signifies the combination of this critical, how-to info with personal and career insights for an enjoyable and thought-provoking read. By providing the full circle of enriching content, PM360 is truly an indispensable tool for busy and productive marketing professionals to stay at the top of their game.

Technology Networks


Technology Networks

Technology Networks is an internationally recognised publisher that provides access to the latest scientific news, products, research, videos and posters. Our global community is made up of over 300,000 researchers and scientific professionals from the life science, drug discover and analytical arenas.




Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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Date and Time

Location

Hyatt Regency Grand Cypress

1 Grand Cypress Boulevard

Orlando, FL 32836

View Map

Refund Policy

No Refunds

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