Trial Master File Summit

JUST ADDED TO THE PROGRAM:
We are also proud to announce that Ann Meeker- O’Connell, Acting Associate Director, Risk Science, Intelligence, and Prioritization, Office of Scientific Investigations, CDER/FDA 
will join the faculty to speak on FDA filing expectations

 

The pharmaceutical industry is one of the world’s largest and most influential industries. Yet, when it comes to maintaining and managing trial master files, they are surprisingly behind the cutting edge in areas such as process improvement and technology. At ExL’s Trial Master File Summit, document managers will share their successes in creating efficient filing systems that are logically integrated with their companies’ way of operating and compatible between departments, sites, CROs, and other external partners.

Upgrading to an electronic filing system can be cumbersome. To reap the benefits, learn from others’ experiences in implementing the change.

You will learn from sessions on:

  • INSPECTION READINESS: Right from the Start, Ready all the Time
  • PORTALS OVERVIEW: How Integrating Portals can Facilitate Communication and Filing
  • ADVANCES IN eTMF TECHNOLOGY: How has technology changed to make eTMF more tenable?
  • REDUCING CLUTTER: What Should be done with Paper After an Upgrade to eTMFs?
  • PROCESS IMPROVEMENT AND MASTER FILES: Streamlining TMF Filing to Reduce

Non-Value-Add Tasks and Inefficiency Throughout the Drug Development Process Our esteemed speaker faculty, are the leaders from top pharma companies who are responsible for the arduous task of overseeing the TMF operations and upgrades. Several have helped create the TMF Reference Model supported by the DIA. If you are responsible for clinical trial documentation, this is a not to be missed event.

Top Five Reasons To Attend:

  1. Learn how leading pharmaceutical companies have developed the infrastructure to efficiently handle the 1000 documents that are part of the TMF
  2. Become inspection ready by making sure all participants are filing regularly as a part of their daily operation procedure
  3. Ensure that the filing process doesn’t detract from the main function of employees and partners
  4. Understand different ways to organize eTMF filing and organization system (eg. folders vs. metadata) to determine which will work best for your company
  5. Effectively monitor trial progress through efficient file management

Who Should Attend

From Pharma, Biotech, Med Device Companies, and CROs, Vice President, Director, Manager, or Heads of:

  • Clinical Operations
  • Document Management
  • Trial Master File
  • Clinical Development
  • Regulatory Operations
  • Product Managers
  • Quality Assurance
  • Quantitative Operations
  • Auditing
  • Global Planning & Standards
  • Project Management
  • Data Management
  • Knowledge Management
  • Records Management
  • Clinical Trials
  • Archives
  • Submission Management
  • Legal
  • IT Compliance

This conference is also of interest to:

  • Technology vendors for filing and database management
  • Consultants for coordinating process management