Publications and Documentation on XEVMPD

Andrew Marr has published several articles on XEVMPD.

The most recent is a further Assessment of the EMA announcements of 31 January 2014, together with subsequent revisions and additional documents.  The article looks at how companies should be responding to this guidance, how they should update their information and then prepare to maintain it.

Previous publications have been:

  • Assessment of the EMA announcements of 31 January 2014
  • Assessment of the status of the implementation¬† of XEVMPD and the challenges ahead (with John Kiser and Wim Cypers (October 2013)
  • Assessment of the revised guidances and other supporting documentation published by EMA on 5 March 2012.
  • Assessment of the status of the programme at year-end 2011
  • Assessment of the EMA announcements of 1 September 2011 and Information Day 23 September 2011
  • Assessment of the EMA announcements of 1 July 2011

EMA’s announcements and documents can be accessed through the following links