EMA schedule a free PSUR webinar training session

The European Medicines Agency (EMA) has announced a joint national competent authority and industry training session on periodic safety assessment reports (PSURs).

The training aims to help develop a uniform understanding of the importance of PSURs.  The plan is to address key difficulties faced by both regulators and industry members and provide guidance on how to manage them. The webinar will take place as a question and answer session covering the following topics:

  • signals and close monitoring
  • safety specification
  • product information / reference safety information
  • use of summary tabulations

The webinar will be a live broadcast which will take place on Friday 22 September 2017 from 09.00am – 11.00am GMT.  Prior registration is not required.  Questions are to be sent in advance to psurtraining@ema.europa.eu

To read the announcement and ultimately, towatch the webinar, please click here.