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Mercure Paris La Défense Grande Arche

Nov 13, 2017 8:00 AM - Nov 14, 2017 4:30 PM

17/20 Esplanade Ch. de Gaulle - Rue des Trois Fontanot, 92000 Nanterre (Paris region), France

Advanced Workshop: QPPV Tool Box – Your Key to Success

ONLY 2 SEATS LEFT! The workshop will allow you to be more efficient in solving the problems in your daily business, and learn the right thinking processes to land at good results.

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SESSION 5: SIGNAL DETECTION AND BENEFIT/RISK ASSESSMENT

Session Chair(s)

Shelley Gandhi, MSc

Strategic Advisor, Pharmacovigilance and Drug Safety

NDA Group, United Kingdom

This session will discuss how the QPPV can supervise and be involved in establishing the safety governance processes for signal detection and benefit-risk assessment, be responsible for the adequacy of documentation describing these processes and their tracking and assure compliance. The QPPV is expected to explain best signal detection practices, the rationale for different methodologies and choice of sources for signal detection and how validation should occur.

Speaker(s)

SIGNAL DETECTION AND BENEFIT/RISK ASSESSMENT

Shelley Gandhi, MSc

NDA Group, United Kingdom

Strategic Advisor, Pharmacovigilance and Drug Safety

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Advanced Workshop: QPPV Tool Box – Your Key to Success

SESSION 5: SIGNAL DETECTION AND BENEFIT/RISK ASSESSMENT

Session Chair(s)

Shelley Gandhi, MSc

Speaker(s)

SIGNAL DETECTION AND BENEFIT/RISK ASSESSMENT

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