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Mercure Paris La Défense Grande Arche

Apr 19, 2016 8:00 AM - Apr 20, 2016 4:30 PM

17/20 Esplanade Ch. de Gaulle - Rue des Trois Fontanot, 92000 Nanterre/Paris, France

The Regulatory Framework in Europe

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SESSION 8: PHARMACOVIGILANCE

Session Chair(s)

Katarina Jelic Maiboe, PhD

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)

Katarina Jelic Maiboe, PhD

PHARMACOVIGILANCE

Katarina Jelic Maiboe, PhD

Denmark

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