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Tutorial 02: IMPLEMENTATION OF THE PHARMACOVIGILANCE LEGISLATION IN THE EU- ACHIEVEMENTS, LESSONS LEARNED AND NEXT STEPS

Mar 25 2014 9:00AM - Mar 25 2014 12:30PM | Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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Overview 

The tutorial will discuss sources of signals from clinical trials to any post authorisation data such as world-wide literature, spontaneous data, post-authorisation safety studies, periodic benefit/risk evaluation reports (PBRER), variations, data from other regulatory bodies such as WHO, EudraVigilance and US FDA AERs. The advantages and disadvantages of methodologies used in signal detection and whether data mining tools really help? How analysis and prioritisation could be carried out and tools which are helpful. We will also consider the impact of communicating these potential safety signals. Finally we will look at database requirements which ensure data quality and minimize the generation of false signals focusing on solutions for large, medium and small enterprises.

Who Should Attend 

  • Pharmacovigilance professionals
  • Statisticians
  • QPPVs and deputy QPPVs
  • Medical Affairs
  • Clinical safety

Learning Objectives 

At the conclusion of this tutorial, participants will be able to:

• Share knowledge about the new pharmacovigilance legislation, overall achievements and lessons learned.

• Discuss key areas of the new pharmacovigilance legislation and further development.

• Understand the preparation for the implementation of the new ISO ICSR/ICH E2B(R3) with main focus on EU specific requirements.

• Discuss recent changes and frequently asked questions in relation to GVP module VI.

Instructor(s) 

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