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 quality control and maintenance of Article 57(2) data and 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:
- Clinical Development
- Information Management
- Safety databases
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.