Pharmacovigilance in the paediatric population workshop

EventCorporatePharmacovigilance

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

English (EN) (138.62 KB - PDF)

First published: 28/08/2014Last updated: 28/08/2014

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

English (EN) (5.28 MB - PDF)

First published: 16/05/2014Last updated: 16/05/2014

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

English (EN) (266.29 KB - PDF)

First published: 16/05/2014Last updated: 16/05/2014

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

English (EN) (531.53 KB - PDF)

First published: 16/05/2014Last updated: 16/05/2014

Presentation - Organ maturation tables (Janina Karres)

English (EN) (675.41 KB - PDF)

First published: 16/05/2014Last updated: 16/05/2014

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

English (EN) (2.27 MB - PDF)

First published: 16/05/2014Last updated: 16/05/2014

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

English (EN) (111.78 KB - PDF)

First published: 16/05/2014Last updated: 16/05/2014

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

English (EN) (110.05 KB - PDF)

First published: 16/05/2014Last updated: 16/05/2014

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

English (EN) (2.23 MB - PDF)

First published: 16/05/2014Last updated: 16/05/2014

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

English (EN) (1.17 MB - PDF)

First published: 16/05/2014Last updated: 16/05/2014

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

DraftReference Number: EMA/785588/2013

English (EN) (75.12 KB - PDF)

First published: 23/04/2014Last updated: 23/04/2014