by chuck_ltd | 22 Jul, 2017 | CHCUK News & Articles, News, NIS, PASS, Real Word Evidence, Real World Evidence
The recently updated EMA page lists questions that marketing-authorisation holders (MAHs) may have on post-authorisation safety studies (PASSs). It provides an overview of the European Medicines Agency’s position on issues that are typically addressed in...
by chuck_ltd | 10 Aug, 2016 | CHCUK News & Articles, GVP, News, NIS, Real Word Evidence
Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev 2) Date for coming into effect of Revision 2 – 9 August 2016 Revision 2 contains the following: Changes to VIII.A., clarifying the link between the...
