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, GVP, News, NIS
European Commission publishes three-year report on implementation of pharmacovigilance legislation Closer collaboration between the European Medicines Agency (EMA), the European Commission and the EU Member States, enabled by the new European pharmacovigilance...
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...
by chuck_ltd | 18 Apr, 2016 | CHCUK News & Articles, GVP, News
Drug companies operating in Russia and other Eurasian Economic Union (“EAEU”) countries are being advised to prepare for the new obligations and liabilities that an impending new regulation on pharmacovigilance in the EAEU might introduce for them. The new...
by chuck_ltd | 1 Mar, 2016 | CHCUK News & Articles, GVP, Pragmatic Trials, Real Word Evidence, Registry, Virtual Clinical Research
Summary The European Medicines Agency is consulting stakeholders on an amended risk management plan (RMP) template, to be used by medicine developers. The revision of the template is based on the principles described in the updated good pharmacovigilance practices...
by chuck_ltd | 16 Dec, 2015 | CHCUK News & Articles, Consultation, GVP, News, NIS, Real Word Evidence, Registry, Virtual Clinical Research
Latest EMA GVP (XVI) Module Update The final Addendum I to Module XVI on educational materials is published, taking into account comments from the public consultation. Further, revision 1 of Module XV on safety communication, with revision 1 of the template for Direct...
