16 - 19 September, 2019 | Pullman Brussels Centre Midi Hotel, Brussels, Belgium
Jamie Toth, Head of TMF Operations at Daiichi Sankyo
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Jamie Toth

Head of TMF Operations
Daiichi Sankyo

Check out the incredible speaker line-up to see who will be joining Jamie.

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Conference Day Two

Wednesday, September 18th, 2019

11:30 AM Keeping your eTMF system and process contemporaneous by following a continuous improvement process (CIP) model

  • Look at the CIP as a system and understand how this evolves  as regulations and users change 
  • Develop your eTMF road map to ensure you have continuous system improvement 
  • Understand why it is crucial to have a good organisational change management system to avoid the ‘3 legged stool’ collapsing and causing disruption to your process

1:50 PM Round table sessions

Use this opportunity to benchmark with your peers and identify the key strategies required to optimize your eTMF process to ultimately ensure inspection readiness. Choose one round table and after 30 minutes rotate round to another topic area of discussion.
  • Identifying and addressing challenges and opportunities when implementing a new eTMF system
  • eTMF road mapping
  • Process change management in an electronic world 
  • Enablement and execution CRO approach to TMFs

4:10 PM Summative Panel: Whats the future for eTMF?

  • Discuss how digital trends are going to influence the way we view eTMF
  • Evaluate your senior support structure to ensure a proactive method of working to get the most out of your eTMF platform 
  • Focus on the regulatory demands and gain clarity on how to maintain adaptation