ESS 1: Non-clinical Regulatory Writing (virtual option available)

8:45 AM - 12:00 PM

• 8:45 AM
  to
  8:55 AM
  

  Welcome
  Carola Krause


• 8:55 AM
  to
  9:20 AM
  

  Introduction to Non-Clinical Regulatory Writing
  Ruggero Galici


• 9:20 AM
  to
  9:45 AM
  

  Avoid Annoying the Regulators: Getting Module 2 Right
  Paul Baldrick


• 9:45 AM
  to
  10:15 AM
  

  Refreshment break
  


• 10:15 AM
  to
  10:40 AM
  

  Nonclinical CTD Modules: What Goes in, Why and How?
  Arthur Noach


• 10:40 AM
  to
  11:05 AM
  

  Safety Assessment of Borderline Products
  Margriet van der Zee


• 11:05 AM
  to
  11:45 AM
  

  Panel discussion