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Crowne Plaza London - The City

05 jun 2018 8:00 a.m. - 06 jun 2018 3:30 p.m.

19 New Bridge Street, London, EC4V 6DB, United Kingdom

Pharmacovigilance Conference

Session 2: The New EudraVigilance (EV) System – Where we are now?

Session Chair(s)

Margaret Anne Walters

Margaret Anne Walters

Deputy EU Qualified Person for Pharmacovigilance

Merck, Sharp & Dohme Ltd, United Kingdom

Major system changes, of which EV is a prime example, inevitably have a settling period during which both technical and procedural issues not seen in testing are likely to arise. The EMA are already aware of many concerns and challenges raised by industry and are addressing them on an urgent basis, plus some more specific challenges can be related to how an MAH has understood and implemented the requirements in their company. This session will review the current situation with respect to ICSR download and (very early) signalling experience, sharing knowledge gained and taking into account perspectives from across Industry (large, small, generics etc.) and Regulators. Additionally, the Panel Discussion will allow participants to directly interact with individuals working on both current issues and future development.

Speaker(s)

Sabine  Brosch, PharmD, PhD, MPharm

Resolving, Ongoing and New Challenges – an ICSR Focus

Sabine Brosch, PharmD, PhD, MPharm

European Medicines Agency, Netherlands

Data Protection Officer

Elspeth  McIntosh, MBA, RN

NEW ICSR Processes - The SME Perspective

Elspeth McIntosh, MBA, RN

Castle Pharmacovigilance Ltd, United Kingdom

Director

Magnus  Ysander, MD

Initial Experience with the E/V Signal Pilot: Practicalities and Possibilities

Magnus Ysander, MD

AstraZeneca, Sweden

EU & UK QPPV & Head Pharmacovigilance Excellence

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