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

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. Now available in individual Modules.

Our outstanding faculty consists of industry representatives and regulators. This is the only course where participants have opportunity to learn and ask from MEB speakers and the Dutch Health Inspectorates directly.

Objectives
Additionally to the five key topics, you should also be able to:
· Understand basic definitions and methods in pharmacovigilance
· Describe the expedited and periodic ICSRs reporting requirements in clinical trials and post-marketing including the medical evaluation
· Understand the process of audits and inspections in pharmacovigilance
· Understand the principles of signal management
· Describe the components of the risk management

Targeted audience
This course will benefit professionals with basic knowledge and experience in Pharmacovigilance or adjacent functions, for example, PV Officers, PV Specialists, PV Experts, PV Coordinators, Heads/Directors/Managers of Regulatory Compliance, Quality or Safety departments.