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RISK-BASED MONITORING – PART I
Session Chair(s)
Estrella Garcia, PhD
Head of Global Clinical Operations
Almirall S.A., Spain
Learning Objective : The objective is to learn how a small-medium size pharma company is going to change the monitoring strategy from a very conventional model to a risk-based monitoring model analyzing the success factors, limitations and challenges.
Speaker(s)
Risk-Based Monitoring – The GCP Inspector's point of view
Catharine Raitt
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
GCP Inspector
Transition from a traditional monitoring strategy towards a risk-based monitoring approach: key learnings and challenges
Idoia Herrero, MSc
Almirall S.A, Spain
Clinical Trial Manager
Evolution on trial management under risk based monitoring approach
Crona Ann O'Conallain, PhD
Quintiles Ireland Ltd, Ireland
Director
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