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Holiday Inn London Kensington Forum

Nov 14, 2016 8:00 AM - Nov 18, 2016 1:30 PM

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

Joint MHRA/DIA Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing

The 5 days of training include a comprehensive overview of the core processes and systems in place and the latest news on the international harmonisation and standardisation activities in pharmacovigilance.

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

Mobile Technologies and Social Media in Signal Management

Phil Tregunno

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

Deputy Director - Patient Safety Monitoring

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