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European Medicines Agency

Dec 07, 2015 8:00 AM - Dec 07, 2015 5:00 PM

30 Churchill Place, Canary Wharf, London, E14 5EU, United Kingdom

EMA Information Day on Services and Systems in Pharmacovigilance

This event will provide marketing-authorisation holders with information on the development of the enhanced systems, helping them prepare for the business change to come.

Session 3: EMA Service of Medical Literature Monitoring for Reports of Suspected Adverse Drug Reactions

Session Chair(s)

Sabine  Brosch, PharmD, PhD, MPharm

Sabine Brosch, PharmD, PhD, MPharm

Data Protection Officer

European Medicines Agency, Netherlands

Margaret Anne Walters

Margaret Anne Walters

Deputy EU Qualified Person for Pharmacovigilance

Merck, Sharp & Dohme Ltd, United Kingdom

This session will focus on the recently launched medical literature monitoring service including the impact of the EMA medical literature service on the NCAs’ and pharmaceutical companies’ business processes and experience to date.

Speaker(s)

Tom  Paternoster-Howe, MSc

How the Service Works and Experience to Date

Tom Paternoster-Howe, MSc

European Medicines Agency, Netherlands

Scientific Administrator, Data Analytics & Methods, Task Force, Healthcare Data

Murielle  Musset, PhD

Industry Experience and Feedback

Murielle Musset, PhD

Sanofi, France

Literature Surveillance Team Lead (Pharmacovigilance)

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