ESS 3: Impact of CTIS on Medical Writing

8:45 AM - 12:00 PM

• 8:45 AM
  to
  8:55 AM
  

  Welcome
  Tracy Farrow Holly Hanson


• 8:55 AM
  to
  9:40 AM
  

  Impact of EU-CTR on Medical Writers and Medical Writing Processes
  Pooja Phogat


• 9:40 AM
  to
  10:25 AM
  

  Impact of CTIS on Medical Writing - Perspective of a Contract Research Organisation (CRO)
  Vivien Fagan


• 10:25 AM
  to
  10:40 AM
  

  Refreshment break
  


• 10:40 AM
  to
  11:25 AM
  

  Impact of EMA Clinical Trial Regulation EU 536/2014 for documents and information to be included in Clinical Trial Information System (CTIS)
  Merete Jørgensen


• 11:25 AM
  to
  12:05 PM
  

  Panel Discussion
  


• 12:05 PM
  to
  12:15 PM
  

  Closing Remarks
  Tracy Farrow Christopher Marshallsay