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Tutorial 03: PRACTICAL TOOLS FOR SIGNAL MANAGEMENT SYSTEMS: HOW DO YOU OVERCOME CHALLENGES AND MEET THE NEEDS OF NEW PHARMACOVIGILANCE LEGISLATION? IS DATA QUALITY IMPORTANT?

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 

Specific topics will be elaborated on with main focus on Good Pharmacovigilance Practices (GVP) module VI, the implementation of the new ISO ICSR/ICH E2B(R3) standard as well as coding and data retrieval principles in relation to medication errors. In addition, an update will be provided on the latest development on the business process for notifications of market cessations and medicinal product withdrawals.

 

This tutorial will provide a forum for stakeholders to obtain an overview of the overall achievements and lessons

 

learned regarding the implementation of the new pharmacovigilance legislation.

 

Who Should Attend 

Qualified Persons Responsible for Pharmacovigilance (QPPVs) and persons involved in:

  • Pharmacovigilance
  • Clinical Development
  • Information Management
  • Safety databases

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 developments.
  • Understand the preparation for the implementation of the new ISO ICSR/ICH E2B(R3) and IDMP standards 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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