4th Trial Master File Summit – 4th 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 documentation. This is important both for the patient and for the sponsor companies to ensure they 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 TMF and how to make the switch to an eTMF system, which could result in greater ease of archiving for TMF professionals. While implementing eTMF can be costly and training employees can be difficult, through eTMF you can ensure realtime monitoring of data to ensure data. This will result in better management of CRO partners and ease the inspection process for sponsor companies.

At ExL Pharma’s 4th 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 TMF will share insights and best practices to facilitate successful TMF management.

Top Five Reasons to Attend

  1. Hear from inspectors which documents they require for your TMF and assemble a TMF toolkit that will allow for immediate access of critical files during an inspection
  2. Discuss where standardization measures stand and add your voice to the debate
  3. Hear a “state of the union” from relevant inspectors and regulatory bodies — such as the FDA and MHRA
  4. Master conversions to eTMF, including staff training and archiving obsolete paper documents
  5. 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