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 | 27 May, 2016 | CHCUK News & Articles, Medical Devices
On Wednesday 25 May the EU institutions reached agreement on the draft texts for the revised Medical Devices Regulation and In Vitro Diagnostics Regulation, which will together replace the existing three Directives regulating devices, active implantable devices and in...
by chuck_ltd | 10 May, 2016 | CHCUK News & Articles, Data Privacy, News, Virtual Clinical Research
The EU Data Protection legislation has been reformed. On 15 December 2015, the European Parliament, the Council and the Commission reached agreement on the new data protection rules, establishing a modern and harmonised data protection framework across the EU. The...
by chuck_ltd | 14 Apr, 2016 | CHCUK News & Articles, News
The European Medicines Agency (EMA) has begun running a series of modular training courses to support stakeholders in using EudraVigilance, the centralized database for managing information on suspected adverse reactions reported with medicines authorised in the...
by chuck_ltd | 24 Mar, 2016 | CHCUK News & Articles, HTA, News, Real Word Evidence, Reimbursement
Date: 16/02/2016 Purpose of the meeting DG SANTE was invited to the EFPIA Working Group on HTA. The purpose of the meeting was to present the EU activities on HTA and to discuss the possible ways of HTA collaboration in the area of relative efficacy (REA) in view of...