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Learn how the regulatory changes will affect your TMF management process!

While we often have to wait patiently for regulators to release new regulations and guidance for the life sciences, in recent years we've seen a dramatic change in pace, with a wealth of new updates coming from regulatory authorities and standards organizations.

In our webinar titled "Navigating the New TMF Regulatory Landscape" Montrium’s Paul Fenton and Christina Mantzioros present the regulatory changes announced in 2018 that will impact trial master files and providing a practical outlook on how to apply them moving forward.

The 50 minute webinar will focus on:

  • The changing regulatory landscape
  • How eTMF systems are shaping the regulations
  • Updates from the MHRA Symposium
  • Overview of the recent EMA guidance
  • Before and after the GCP E6 (R2) update
  • 21 CFR Part 11 for Trial Master File (recent update)
  • Practical considerations for 2018
  • The "State of the Union" of the TMF Landscape
  • And much more...

Your Presenters:



Christina Mantzioros

Clinical Solutions Specialist


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Paul round

Paul Fenton

President & CEO


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