How will you navigate the new TMF regulatory landscape?

Many organizations today still struggle to develop effective compliance strategies. In recent years we have seen a dramatic change in pace from regulatory authorities and standards organizations. With a wealth of new updates coming in, it is becoming increasingly more complex to remain compliant. With this in mind, our upcoming webinar will focus on the recent regulatory changes that will impact trial master files and provide a practical outlook on how to apply them and stay one step ahead.

The webinar will cover the following topics:

• 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 & applications for 2019 and beyond
• The "State of the Union" of the TMF Landscape
• And much more...