Journal of Pharmacovigilance

European pharmacovigilance under EudraVigilance and the extended EudraVigilance medicinal products dictionary (XEVMPD) environment within it

4^th International Conference and Exhibition on Pharmacovigilance & Clinical Trials

August 10-12, 2015 London, UK

Alistair Coates

Scientific Tracks Abstracts: J Pharmacovigilance

Abstract:

EudraVigilance is a data processing network and management system for reporting and evaluating suspected ADRs during the development and following the marketing authorisation of medicinal products in the EEA. EudraVigilance is also one of the main pillars of the European Risk Management Strategy, which strengthens the conduct of pharmacovigilance in the EEA. It facilitates the process of risk management at several levels including aspects of risk detection, risk assessment, risk minimisation and risk communication. Consequently, EudraVigilance contributes to the protection and promotion of public health in the EEA. Furthermore, it provides a powerful tool for the safety monitoring of medicinal products and in minimising potential risks related to suspected ADRs.

Biography :

Alistair Coates is the UK Business Advisor for Oviya MedSafe. Current clients range from start-up companies to established pharmaceutical companies in Europe, the US and the rest of the world. He offers an independent, expert, consultancy services to the pharmaceutical, medical devices and biotechnology industries for Clinical Drug Safety and Pharmacovigilance. His career within the pharmaceutical industry spans over two decades, where he has been involved with pre-clinical pharmacology, premarketing Clinical Drug Safety and Clinical Data Management, post-marketing Pharmacovigilance and medical device vigilance. He holds a degree in pharmacology and he has a subsequent qualification in Pharmacovigilance.