2016 annual workshop of the European network of paediatric research (Enpr-EMA) at the European Medicines Agency

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Title2016 annual workshop of the European network of paediatric research (Enpr-EMA) at the European Medicines Agency
Date02/06/2016 - 03/06/2016
LocationEuropean Medicines Agency, London, UK
SummaryThe first day of the workshop is an open meeting to all stakeholders, including patient and parent organisations, network representatives, pharmaceutical industry staff responsible for paediatric studies and regulators. The main topics of the workshop this year will be the deliverables of the working groups and the implementation of the new Clinical Trial Regulation with a focus on ethics related issues. The second day is dedicated to members of Enpr-EMA and its coordinating group.

All documents

Name Language First published Last updated
Report of the 2016 annual workshop of the European Network of Paediatric Research at EMA (Enpr-EMA), 2-3 June 2016 (English only) 2016-10-28  
Minutes of the 2016 annual face to face meeting of the Enpr-EMA Coordinating Group members - 3 June 2016 (English only) 2016-10-28  
Presentation - Update on the IMI2 Proposal to Build a Sustainable pan-European Paediatric Clinical Trials Network (William R Treem) (English only) 2016-10-28  
Agenda - 2016 annual workshop of the European network of paediatric research at the EMA (Enpr-EMA) (English only) 2016-04-14 2016-06-28
Agenda: 2016 annual meeting of Enpr-EMA members (English only) 2016-06-28  
Agenda: 2016 annual face to face meeting of the Enpr-EMA Coordinating Group members (English only) 2016-06-28  
Presentation: Report from the coordinating group (CG) Update on Enpr-EMA activities, achievements and challenges (English only) 2016-06-28  
Presentation: Dialogue and interaction with ethics committees (English only) 2016-06-28  
Presentation: Standard Operating Procedure for meetings about generic issues in paediatric drug development convened by Enpr-EMA (English only) 2016-06-28  
Presentation: Educational Training of Research Staff Involved in Paediatric Clinical Trials / GCP Training across multispecialty and countries (English only) 2016-06-28  
Presentation: Working Group on public-private partnership (English only) 2016-06-28  
Presentation: Young Persons Advisory Groups Terms of Reference and updated Work Plan (English only) 2016-06-28  
Presentation: OKIDS activity update, learnings and improvements (English only) 2016-06-28  
Presentation: What ever happened to the IMI2 proposal? (English only) 2016-06-28  
Presentation: NICHD - Pediatric Trials Network (English only) 2016-06-28  
Presentation: Successful IMI project: INNODIA (English only) 2016-06-28  
Presentation: EPCTRI: Paediatrics in 2016. Roadmap of European Strategy Forum for Research Infrastructure (ESFRI) (English only) 2016-06-28  
Presentation: How can the informed consent process better address the needs of parents/children? (English only) 2016-06-28  
Presentation: The EU Clinical Trial Regulation and children and young people (minors) - Ethical and procedural issues (English only) 2016-06-28  
Presentation: Networking of European REC's (English only) 2016-06-28  
Presentation: Paediatric specific and ethics issues related to implementation of Clinical Trial Regulation (English only) 2016-06-28  
Presentation: Ethical considerations for clinical trials on medicinal products conducted with the paediatric population (English only) 2016-06-28  
Presentation: Involvement of children - iCAN (English only) 2016-06-28  
Presentation: Update from EMA Workshop on extrapolation of efficacy in children (English only) 2016-06-28  
Presentation: Improving new drug development for children and adolescents: The ACCELERATE initiative (English only) 2016-06-28  
Presenation: PDCO perspectives & proposals - Enpr-EMA coordinating group (English only) 2016-06-28  
Presenation: Severe Paediatric Asthma Collaborative in Europe (SPACE) (English only) 2016-06-28  
Presenation: Update on new Enpr-EMA Paediatric Antibiotic Clinical Trial Working Group (English only) 2016-06-28  

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