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European Medicines Agency

Mar 12, 2014 8:15 AM - Mar 12, 2014 5:00 PM

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

15th EudraVigilance Information Day

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Session 3: Signal Management

Session Chair(s)

Sabine Brosch, PharmD, PhD, MPharm

Sabine Brosch, PharmD, PhD, MPharm

Data Protection Officer

European Medicines Agency, Netherlands

As of September 2013, PRAC recommendations on signals are published on a monthly basis. This session provides an overview of signals related activities from a regulators’ and pharmaceutical industry’s perspective.

Speaker(s)

Sabine Straus, MD, PhD, MSc

Management of signals from an EU regulator’s perspective

Sabine Straus, MD, PhD, MSc

Medicines Evaluation Board (MEB), Netherlands

PRAC Chair, Staff Member

Georgy Genov, MD

Management of signals from an EMA perspective

Georgy Genov, MD

European Medicines Agency, Netherlands

Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department

Laurent Auclert, MD

Experience with PRAC signals (follow-up and communication) from an industry perspective

Laurent Auclert, MD

France

Pharmacovigilance Expert

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