• By ICR Secretariat
  • Posted Wednesday, May 10, 2017

UK Pharmacovigilance Post-Brexit: Lots of Questions, Few Answers

http://www.raps.org/Regulatory-Focus/News/2017/05/01/27450/UK-Pharmacovigilance-Post-Brexit-Lots-of-Questions-Few-Answers/?mc_cid=474ff3f393&mc_eid=%5bUNIQID%5d

At last weeks Forum on UK Pharmacovigilance Post-Brexit, a lot of hypotheticals were discussed, but little was said to calm the fears of Qualified People Responsible for Pharmacovigilance. Currently, EU Regulations state that they must work from the EU, so for the large number of QPPV leaders in the UK Brexit represents a serious threat. Ian Hudson, chief executive of MHRA since 2013, said recently that there has been discussion of outsourcing some regulatory work from the UK, but, "We don’t know what that outsourcing will look like."