5th Trial Master File Summit – 5th Trial Master File Summit

Regulators worldwide require sponsor companies to assemble a comprehensive Trial Master File during clinical trials. This means filing and maintaining hundreds of thousands of clinical documents. This is important for both patients and sponsor companies as it ensures that companies are ready for inspection and that GCP guidances are being followed.

In recent years, there has been much discussion regarding what documents should be included in a TMF and how to make the switch to an eTMF system, which could make archiving easier for TMF professionals. While implementing an eTMF can be costly and training employees can be difficult, you can ensure real-time monitoring of data to ensure accuracy by using an eTMF. This results in better management of CRO partners and eases the inspection process for sponsor companies.

At ExL Pharma’s 5th Trial Master File Summit, TMF experts will discuss best practices for developing, managing and monitoring a TMF process that is regulatory compliant for audits and inspections. TMF process owners, quality assurance, clinical, regulatory and information technology professionals who are responsible for Trial Master Files will share insights and best practices to facilitate successful TMF management.

Top Five Reasons to Attend

  1. Discuss where standardization measures, including the TMF Reference Model and OASIS, stand and add your voice to the debate
  2. Hear a “state of the union” from relevant inspectors and regulatory bodies, such as the FDA and the MHRA
  3. Master conversions to eTMF, including staff training and archiving obsolete paper documents
  4. Hear from inspectors regarding which documents they require for your TMF and assemble a TMF tool kit that will allow for immediate access to critical files during an inspection
  5. Learn about advancements in technologies supporting TMF, including cloud-based solutions and eTMF platforms

Who Should Attend

This conference is designed for professionals from pharmaceutical, biotechnology and medical device companies with responsibilities in the following areas:

  • Clinical Operations
  • Document Management
  • Regulatory Affairs
  • TMF and eTMF
  • Data Management
  • Clinical Document Coordination
  • Document and Record Specializations
  • Clinical Development
  • Regulatory Operations
  • Essential Document Management
  • Quality Assurance and Operations
  • Knowledge Management
  • Global Planning and Standards
  • Strategic Clinical Operations and Planning
  • Clinical Trial Management
  • Quality Management
  • Informatics
  • Clinical Information Technology

This conference is also of interest to:

  • TMF Service Providers
  • Data/Records Management Vendors
  • CROs
  • Consultants