RMP and PSUR in life-cycle management: An art, not a miracle - Seminar / Kurs von FORUM Institut für Management GmbH

Insights into RMP and PSUR preparation, assessment and regulatory management

Inhalte

- RMP management in the post-authorisation phase - Insights in pharmacovigilance writing and QPPV oversight - Impact of EU assessment reports on RMPs and PSURs - Effective global management and harmonisation of RMPs and PSURs - Additional risk minimisation measuresTips & tricks for managing periodic reports and risk management plans post marketing authorisation. Furthermore insights into global PV document management will be given. Thus the training course gives you an allround overview.

Lernziele

This seminar provides insights into RMP and PSUR preparation, assessment and regulatory management. After completing the seminar, you will: - be able to understand and handle your RMP correctly according to the current guidelines; - be familiar with the tasks and duties of a QPPV in the lifecycle of a marketing authorisation; - know the tips and tricks for strategic planning and project coordination as a pharmacovigilance writer; - be able to handle EU assessment reports and understand their impact on RMPs and PSURs; - have a good understanding of the planning, preparation and management of additional risk-minimisation measures.Insights into the global management of pharmacovigilance documents round off this seminar.

Zielgruppen

This seminar is intended for those working in the pharmaceutical industry already having profound knowledge of pharmacovigilance writing (with a focus on PSUR and RMP). QPPVs and people responsible for national pharmacovigilance are also invited to join the intensive discussion.

Termine und Orte

Datum Preis
Bonn, DE
26.03.2020 Jetzt buchen ›

SG-Seminar-Nr.: 5327155

Anbieter-Seminar-Nr.: 39276

Termine

  • 26.03.2020

    Bonn, DE

Preise inkl. MwSt. Es können Gebühren anfallen. Für eine exakte Preisauskunft wählen Sie bitte einen Termin aus.

Jetzt buchen ›
Seminar merken ›

Semigator berücksichtigt

  • Frühbucher-Preise
  • Last-Minute-Preise
  • Gruppenkonditionen

und verfügt über Sonderkonditionen mit einigen Anbietern.

Der Anbieter ist für den Inhalt verantwortlich.

Über Semigator mehr erfahren

  • Anbietervergleich von über 1.500 Seminaranbietern
  • Vollständige Veranstaltungsinformationen
  • Schnellbuchung
  • Persönlicher Service
Datum Preis
Bonn, DE
26.03.2020 Jetzt buchen ›