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NH Berlin Alexanderplatz

25 abr 2017 8:00 a.m. - 26 abr 2017 4:30 p.m.

Landsberger Allee 26-32, 10249 Berlin, Germany

Essentials and Overview of the Regulatory Framework in Europe

ONLY 1 OFFERING IN 2017! The course will give an overview of the European regulatory system for human medicines.

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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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