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Holiday Inn London Kensington Forum

Sep 28, 2015 8:00 AM - Oct 02, 2015 1:00 PM

97 Cromwell Road, London, SW7 4DN, United Kingdom

Joint MHRA/DIA Excellence in Pharmacovigilance

This course is designed to provide a firm grounding in key aspects of Global and mainly European Clinical Pre- and Post-Marketing Safety regulatory requirements

TOPIC 4: SIGNAL DETECTION AND SIGNAL MANAGEMENT

Session Chair(s)

Gaby L. Danan, MD, PhD

Gaby L. Danan, MD, PhD

Pharmacovigilance Expert

GLD, France

Phil  Tregunno

Phil Tregunno

Deputy Director - Patient Safety Monitoring

Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

New safety signals may emerge at any time following product launch and must be evaluated for relative risk, medical importance, and likelihood of occurrence. This session will provide approaches to signal detection using quantitative methods illustrated in a workshop with examples as well as general considerations on signal management in the EEA.

Speaker(s)

Phil  Tregunno

Introduction to Signal Detection

Phil Tregunno

Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Deputy Director - Patient Safety Monitoring

Phil  Tregunno

Signal Management in the European Union: Regulatory Network Perspective

Phil Tregunno

Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Deputy Director - Patient Safety Monitoring

Jan  Petracek, MD, MSc

Signal Management in the European Union: Industry Perspective

Jan Petracek, MD, MSc

Ivigee, Czech Republic

CEO

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