Sofus Talks about eSubmission

eSubmission, a changing field - are you prepared?

In the coming years, there will be major changes in eSubmission that will affect practical regulatory work.

Welcome to hear Sevim Hasözbek and Rolf Eriksson from Sofus Head Office Regulatory Affairs present news in the field. Among the issues addressed are:

  • What are EMA and ICH doing in eSubmissions?
  • When will the eCTD be mandatory for national products?
  • What is SPOR and how will it affect our daily work?
  • When will the eApplication Form disappear and what will replace it?

Sofus Talks are short lectures on current and interesting topics in regulatory affairs. We offer coffee and light snacks.