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Pharmacovigilance (Legislation 2010 (Mediator 2012 (Amended legislation)),…
Pharmacovigilance
Legislation 2010
Mediator 2012
Amended legislation
Eudravigilance
benefits
PSUR
ICSR
Patients reporting
positive or negative
Zydelig
Case Study
New legislation
PRAC involvement
RECOMMENDATIONS
PRAC
Communication channels
RMP
QPPV
PMSF
Safety signals