Pharmacovigilance in the paediatric population workshop

• Date:
  Monday, 28 April 2014, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The aim of this workshop is to address the needs and priorities for pharmacovigilance in the paediatric population. The objectives are to outline the current work performed at the European Medicines Agency with regard to paediatric safety, and to discuss the potential for improvement in terms of active paediatric pharmacovigilance.

Documents

Report on the European Medicines Agency workshop of pharmacovigilance in the paediatric population

Reference Number: EMA/288486/2014

Presentation - A pharmacovigilance project in juvenile idiopathic arthritis (JIA) - Pharmachild the PRINTO perspective (Nicola Ruperto)

Presentation - Adverse drug reactions in paediatric oncology (Ralf Herold)

Presentation - Descriptive overview of paediatric versus adult adverse drug reactions in EudraVigilance (Kevin Blake)

Presentation - Organ maturation tables (Janina Karres)

Presentation - Pharmacovigilance in paediatric population - The PRAC's perspective (June Raine)

Presentation - Proposals for strengthening the interaction between PDCO and PRAC (Benjamin Pelle)

Presentation - Revision of the guideline on conduct of pharmacovigilance for medicines used by the paediatric population (Dirk Mentzer)

Presentation - Routine signal detection and statistical tools on paediatrics (Cosimo Zaccaria)

Presentation - Update on the standard EudraVigilance paediatric query (Cosimo Zaccaria)

Agenda - Preliminary agenda of the pharmacovigilance in the paediatric population workshop

Draft Reference Number: EMA/785588/2013