Enpr-EMA activities

  • Email
  • Help

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

Back to top

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

Back to top

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

Back to top

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

Back to top

Newsletters

Back to top

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