by Stuart McCully | 28 May, 2019 | Consultation, NIS, Real Word Evidence, Safety Management
ICH has released a new E series guideline for consultation: ICH E19 – Optimisation of Safety Data Collection Objective of the Guideline This Guideline is intended to provide internationally harmonised guidance on an optimised approach to safety data collection...
by chuck_ltd | 14 Feb, 2017 | CHCUK News & Articles, Safety Management
The Ministry of Food and Drug Safety of Korea (the “MFDS”) announced major policy initiatives in the pharmaceutical sector for 2017 on January 9, 2017 (the “Policy Initiative”) With respect to pharmaceuticals, the MFDS declared plans to select...
