Enpr-EMA activities

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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

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Document(s) Language Status First published Last updated Effective Date
Informed consent for paediatric clinical trials in Europe 2015 (English only)   2015-12-18 2018-05-28  
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

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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

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Document(s) Language Status First published Last updated Effective Date
Minutes of the European network of paediatric research at the European Medicines Agency coordinating group members meeting - 6 October 2016 (English only)   2016-11-24    
Minutes of the 2016 annual meeting of Enpr-EMA members - 3 June 2016 (English only)   2016-10-28    
Minutes of the seventh annual European network of paediatric research at the European Medicines Agency (Enpr-EMA) members face to face meeting (English only)   2015-08-05    
Minutes of the European network of paediatric research at the European Medicines Agency coordinating group teleconference - 21 January 2015 (English only)   2015-03-09    
Presentation - European network of paediatric research-European Medicines Agency working groups 3 / 5: How to establish communication between Enpr-EMA networks and industry / sharing good practice within Enpr-EMA and with industry partners (Susan Tancey) (English only)   2015-03-09    
Minutes of the European network of paediatric research-European Medicines working groups meeting 23 January 2014 (English only)   2014-03-21    
Presentation - European network of paediatric research-European Medicines Agency working groups 3 / 5: How to establish communication between Enpr-EMA networks and industry / sharing good practice within Enpr-EMA and with industry partners (Susan Tancey) (English only)   2014-03-21    
Presentation - European network of paediatric research-European Medicines Agency working group 4: Dialogue and interaction with ethics committees (Allison Needham) (English only)   2014-03-21    

Enpr-EMA workshops

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Newsletters

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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