Risk Management Plans: reassessment of safety concerns based on Good Pharmacovigilance Practices Module V (Revision 2)-a company experience

• Main Authors: Suzan Esslinger (Author), Linda Quinn (Author), Sami Sampat (Author), Marijo Otero-Lobato (Author), Wim Noël (Author), Anja Geldhof (Author), Nicole Herijgers (Author), Sarah-Jane Reeder (Author)
• Format: Book
• Published: BMC, 2022-05-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract Introduction In the European Union (EU), a Risk Management Plan (RMP) is submitted as part of the dossier for initial marketing authorization of a medicinal product or with an application involving a significant change to an existing marketing authorization. A comprehensive revision of the...