At the 2014 World Drug Safety Congress Americas, Mariska Kooijmans, Biogen Idec, gave a presentation on “New EU Good Vigilance Practices Legislation.”
Download and learn:
- Background and goals EU PV Legislation
- EU GVP Modules – major changes
- PV Quality Requirements
- Pharmacovigilance Systems Master File (PSMF)
- Biogen Idec approach to implementation
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