Early October Meeting

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When: 10:00 EDT, 04Oct2018
Place: GoTo Meeting
Facilitator: Wendy Dobson
Scribe: Wendy Dobson
Agenda: General Discussion

Co-lead Update

  • Wendy made a call for a co-lead to help support Jared. No one has come forward yet.

Educational Videos

  • Mary discussed that she is still keen to do educational videos. During our face to face CSS meeting back in March Alan mentioned about potential FDA courses that could be shared.

Action: Mat to investigate further and see what is useful

Clinical Review Template

  • It was finalised in December 2017 but has still not been made public.
  • FDA are looking at modernising drug review and the CRT may no longer be relevant.
  • Could be moving in the direction of Uni-Review.
  • Keep on radar.


  • Mat submitted an abstract and is awaiting feedback. We reviewed their training models on line but these are at a cost.

Action Items

  • Jared: By next meeting, combine all outstanding actions from previous meetings to establish what is outstanding. To also include in the next agenda, the High, Medium and Low goals so we can start to plan for 2019
  • Mat: investigate FDA courses further and see what is useful
  • Mary: produce some promotional materials for the Working Groups PhUSE booth at Frankfurt EU Connect; seek budget approval from Lilly for DIA

Last revision by Jared s,10/8/2018