14th September 2017

From PHUSE Wiki
Jump to: navigation, search

Attendees: Dan, Tony, Hans-Peter, Lawrence, Evi, Larry, Chris, Bill, Richard, Bob, Suzanne, Lauren

Apologies: Karnika

Discussion

  • Tony- The guidance has not been formulated and is not sitting with the office commissioner. Crystal has offered to try and get a definitive answer to what has happened
  • Bob- Still need to meet with Serena to discuss the supporting document
  • Bob met with Bill who was going to draft a few questions/answers and send over to potentially use as a new scenario on the document (Security and uncertainty)
  • Deadline for scenario document -Publish independently of the framework document as a supporting document so that we can continually add to
  • Suzane – German inspectors inforce pharmaceutical companies indicate the location of all their external site master files
  • Site master file will be under control of the manufacture pharmaceutical company who runs it


Actions

  • Bob and Evi - To put together the supporting document and focus on the content for the PhUSE conference within the next two weeks (28/09/17)
  • Chris - Format the document
  • Tony- Put a slide together with the updated version of the framework document and version 1 of the scenario document. One slide with talking points with what the updates and links are
  • Evi - Pick up the names of who we spoke to at Novartis
  • Chris - To update the contributors list on the framework document
  • Tony - To review the paper once completed