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BEST PRACTICES IN PHARMACOVIGILANCE GOVERNANCE
Session Chair(s)
Jan-Willem van der Velden, DrMed
CEO
Mesama Consulting, Switzerland
The Growing Importance of Independent Adjudication for Post Marketing Studies
Learning Objective : 1. Recognize the increasing application of independent adjudication to adverse events in post-marketing studies 2. Define best practices and technologies enabling independent adjudication and removing bias 3. Discuss where global regulations are headed for independent adjudication
Speaker(s)
The Growing Importance of Independent Adjudication for Post Marketing Studies
Donna Davison
INC Research, United States
Director, Medical Operations
How can we build reliability and quality when outsourcing pharmacovigilance?
Brian Edwards, DrMed
International Society of Pharmacovigilance, United Kingdom
Vice President
The Pharmacovigilance System Master File
Maria Wishart
Astrazeneca, United Kingdom
Medical Director, Global Patient Safety
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