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This page presents various activities of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA).
It includes highlights from the ad hoc working groups set up to develop pragmatic responses to important needs identified at the the fifth annual Enpr-EMA workshop in June 2013.
Table of contents
- General
- Working groups: mandate
- Working groups: minutes and presentations
- Enpr-EMA workshops
- Newsletters
General
Document(s) | Language | Status | First published | Last updated | Effective Date |
---|---|---|---|---|---|
Informed consent for paediatric clinical trials in Europe 2015 | (English only) | 2015-12-18 | 2017-06-20 | ||
Comments on Revision of Clinical Trials Directive 2001-20 On behalf of the European network of paediatric research at the EMA | (English only) | 2014-03-21 | |||
Comments on Revision of Clinical Trials Directive 2001-20 On behalf of the European network of paediatric research at the EMA | (English only) | 2014-03-21 | |||
Response to the concept paper for public consultation on the Commission guideline on the format and content of applications for paediatric investigation plans | (English only) | 2014-03-21 | |||
Response to general report on experience acquired as a result of the application of the paediatric regulation of 19 September 2012 submitted for public consultation by the European Commission on ‘experience acquired’ and ‘lessons learnt’ | (English only) | 2012-12-20 |
Working groups: mandate
Document(s) | Language | Status | First published | Last updated | Effective Date |
---|---|---|---|---|---|
Mandate of the European network of paediatric research-European Medicines Agency working groups | (English only) | 2014-03-21 | 2018-03-02 |
Working groups: minutes and presentations
Enpr-EMA workshops
Related links
- European Network for Paediatric Research at the European Medicines Agency (Enpr-EMA) awareness webinar (01/12/2016)
- European network of paediatric research-European Medicines Agency meeting on rare gastrointestinal and liver diseases (08/12/2015)
- Collaboration on neonatal issues between researchers and the European Medicines Agency (17/03/2015)
Newsletters
Document(s) | Language | Status | First published | Last updated | Effective Date |
---|---|---|---|---|---|
European network of paediatric research at the European Medicines Agency newsletter: 2017 | (English only) | 2018-03-02 | |||
European network of paediatric research at the European Medicines Agency newsletter: December 2016 | (English only) | 2017-01-04 | |||
European network of paediatric research at the European Medicines Agency newsletter: January 2016 | (English only) | 2016-03-14 | |||
European network of paediatric research at the European Medicines Agency newsletter: February 2015 | (English only) | 2015-03-10 | |||
European Network of Paediatric Research at the European Medicines Agency newsletter: December 2013 | (English only) | 2014-01-16 | |||
European network of paediatric research-European Medicines Agency newsletter December 2012 | (English only) | 2014-03-21 |