2016 annual workshop of the European network of paediatric research (Enpr-EMA) at the European Medicines Agency
Date:
02/06/2016 to 03/06/2016
Location:
European Medicines Agency, London, UK
The 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.
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Report of the 2016 annual workshop of the European Network of Paediatric Research at EMA (Enpr-EMA), 2-3 June 2016 (PDF/193.46 KB)
First published: 28/10/2016
Last updated: 28/10/2016
EMA/408587/2016 -
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Minutes of the 2016 annual face to face meeting of the Enpr-EMA Coordinating Group members - 3 June 2016 (PDF/161.58 KB)
First published: 28/10/2016
Last updated: 28/10/2016
EMA/403089/2016 -
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Presentation - Update on the IMI2 Proposal to Build a Sustainable pan-European Paediatric Clinical Trials Network (William R Treem) (PDF/342.75 KB)
First published: 28/10/2016
Last updated: 28/10/2016 -
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Agenda - 2016 annual workshop of the European network of paediatric research at the EMA (Enpr-EMA) (PDF/109.98 KB)
Adopted
First published: 14/04/2016
Last updated: 28/06/2016
EMA/795122/2015 -
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Agenda: 2016 annual meeting of Enpr-EMA members (PDF/74.48 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Agenda: 2016 annual face to face meeting of the Enpr-EMA Coordinating Group members (PDF/81.01 KB)
First published: 28/06/2016
Last updated: 28/06/2016
EMA/204746/2016 -
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Presentation: Report from the coordinating group (CG) Update on Enpr-EMA activities, achievements and challenges (PDF/508.38 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: Dialogue and interaction with ethics committees (PDF/229.38 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: Standard Operating Procedure for meetings about generic issues in paediatric drug development convened by Enpr-EMA (PDF/56.23 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: Educational Training of Research Staff Involved in Paediatric Clinical Trials / GCP Training across multispecialty and countries (PDF/542.66 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: Working Group on public-private partnership (PDF/906.31 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: Young Persons Advisory Groups Terms of Reference and updated Work Plan (PDF/154.9 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: OKIDS activity update, learnings and improvements (PDF/2.89 MB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: What ever happened to the IMI2 proposal? (PDF/249.95 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: NICHD - Pediatric Trials Network (PDF/222.8 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: Successful IMI project: INNODIA (PDF/1.47 MB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: EPCTRI: Paediatrics in 2016. Roadmap of European Strategy Forum for Research Infrastructure (ESFRI) (PDF/376.33 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: How can the informed consent process better address the needs of parents/children? (PDF/190.81 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: The EU Clinical Trial Regulation and children and young people (minors) - Ethical and procedural issues (PDF/77.12 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: Networking of European REC's (PDF/149.18 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: Paediatric specific and ethics issues related to implementation of Clinical Trial Regulation (PDF/100.95 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: Ethical considerations for clinical trials on medicinal products conducted with the paediatric population (PDF/366.86 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: Involvement of children - iCAN (PDF/4.33 MB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: Update from EMA Workshop on extrapolation of efficacy in children (PDF/102.9 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: Improving new drug development for children and adolescents: The ACCELERATE initiative (PDF/1.61 MB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation - PDCO perspectives & proposals - Enpr-EMA coordinating group (PDF/125.66 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: Severe Paediatric Asthma Collaborative in Europe (SPACE) (PDF/145.54 KB)
First published: 28/06/2016
Last updated: 28/06/2016 -
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Presentation: Update on new Enpr-EMA Paediatric Antibiotic Clinical Trial Working Group (PDF/139.57 KB)
First published: 28/06/2016
Last updated: 28/06/2016