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A TMF is not only a living archive of a clinical trial’s progress — it is a record required by regulatory authorities and is critical for clinical oversight. By developing, implementing and utilizing a TMF plan, you will be able to monitor a trial’s progress, ensure high-quality documents and be prepared for an inspection. Additionally, creating a TMF means that clinical trial sponsors, CROs and sites can demonstrate that they are meeting GCPs during trials, whether an inspection is conducted by the MHRA, EMA, PMDA or FDA.

At the 2nd Asia-PAC Trial Master File Summit, 15+ speakers will address:

  • Ways to increase quality by implementing QC
  • How to implement and utilize TMF metrics
  • Necessary documents to include in a TMF
  • Preparation strategies for an inspection
  • Methods for selecting when to use a CRO’s eTMF versus an internal system
  • How an eTMF system can increase quality
  • Training and staffing needs for a TMF
  • Methods for improving clinical operations in TMF management
  • TMF milestones and SOPs to ensure timely document submission
  • Preparation for when regulatory authorities are asking for eTMF access

And much more!

Top Five Reasons to Attend

  1. Explore best practices to develop or enhance a TMF management process
  2. Understand how to best prepare for an inspection
  3. Explore all the options of CRO oversight when using their eTMF
  4. Learn how to implement or roll out an eTMF that will meet the needs of your organization and global regulatory authorities
  5. Network with 75+ global trial master file professionals

Testimonials

"Great event to explore various phases that exist in an eTMF rollout in Japan."

"There is no other event this specifically tailored to TMF matters that we would go to."

"Very exciting summit, it is of great help to consider how the sponsor deals with eTMFs at the regional and global levels."

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