by Syneos Health_1 | 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 | 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...
by chuck_ltd | 10 Aug, 2016 | CHCUK News & Articles, Consultation, GVP
Draft guideline on good pharmacovigilance practices (GVP) – Module IX – Signal management (Rev. 1) Regulation (EC) No 726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 (hereinafter referred to as REG, DIR and IR,...
by chuck_ltd | 10 Aug, 2016 | CHCUK News & Articles, Consultation, GVP, News, NIS
Draft guideline on good pharmacovigilance practices (GVP) – Module VI – Management and reporting of adverse reactions to medicinal products (Rev. 2) This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC 183 and Chapter...
