Back to Agenda
Eudravigilance, the New ICH E2B(R3) ICSR and the EU Telematics Programme - How to Prepare For Change
Session Chair(s)
Sabine Brosch, PharmD, PhD, MPharm
Data Protection Officer
European Medicines Agency, Netherlands
The new EudraVigilance system will be subject to an independent audit in the 1st quarter of 2017. Six months following the announcement of the successful outcome of the audit, major business process changes will apply including the use of the new ICH E2B(R3) format. NCAs and pharmaceutical companies need to prepare for these important changes. Initiatives to improve operational efficiencies in support of data evaluation will be also presented.
Learning Objective : Describe ISO/E2B(R3) ICSR implementation planning in the EU and beyond Understand how the adverse reaction reporting and analysis in EudraVigilance will change based on the new E2B(R3) format Discuss pharmacovigilance system changes to come Describe the EudraVigilance change management planning and training programme
Speaker(s)
The New EudraVigilance System – Change Management Planning in the EU and a Pperspective from a Member State
Fatima Hergy, PharmD
INFARMED - Autoridade Nacional do Medicamento , Portugal
Pharmacist, Pharmacovigilance and process manager
Change Management Planning - A Perspective of the Pharmaceutical Industry
Margaret Anne Walters
Merck, Sharp & Dohme Ltd, United Kingdom
Deputy EU Qualified Person for Pharmacovigilance
Mick Foy
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Director of Delivery
Have an account?