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SESSION 8: PHARMACOVIGILANCE
Session Chair(s)
Katarina Jelic Maiboe, PHD
Denmark
- Pharmacovigilance legislation
- Post-authorisation Safety Study (PASS) & Post-Authorisation Efficacy Study (PAES)
- Dossier requirements: Risk Management Plan (RMP), Periodic Safety Update Report (PSUR)
- Safety procedures / referrals
- Pharmacovigilance Risk Assessment Committee (PRAC)
Speaker(s)
PHARMACOVIGILANCE
Katarina Jelic Maiboe, PHD
Denmark
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