Date
- Thursday, 02 June 2016
Location
- European Medicines Agency, Amsterdam, the Netherlands
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.
Documents
Report of the 2016 annual workshop of the European Network of Paediatric Research at EMA (Enpr-EMA), 2-3 June 2016
English (EN) (193.46 KB - PDF)
Minutes of the 2016 annual face to face meeting of the Enpr-EMA Coordinating Group members - 3 June 2016
English (EN) (161.58 KB - PDF)
Presentation - Update on the IMI2 Proposal to Build a Sustainable pan-European Paediatric Clinical Trials Network (William R Treem)
English (EN) (342.75 KB - PDF)
Agenda - 2016 annual workshop of the European network of paediatric research at the EMA (Enpr-EMA)
English (EN) (109.98 KB - PDF)
Agenda: 2016 annual meeting of Enpr-EMA members
English (EN) (74.48 KB - PDF)
Agenda: 2016 annual face to face meeting of the Enpr-EMA Coordinating Group members
English (EN) (81.01 KB - PDF)
Presentation: Report from the coordinating group (CG) Update on Enpr-EMA activities, achievements and challenges
English (EN) (508.38 KB - PDF)
Presentation: Dialogue and interaction with ethics committees
English (EN) (229.38 KB - PDF)
Presentation: Standard Operating Procedure for meetings about generic issues in paediatric drug development convened by Enpr-EMA
English (EN) (56.23 KB - PDF)
Presentation: Educational Training of Research Staff Involved in Paediatric Clinical Trials / GCP Training across multispecialty and countries
English (EN) (542.66 KB - PDF)
Presentation: Working Group on public-private partnership
English (EN) (906.31 KB - PDF)
Presentation: Young Persons Advisory Groups Terms of Reference and updated Work Plan
English (EN) (154.9 KB - PDF)
Presentation: OKIDS activity update, learnings and improvements
English (EN) (2.89 MB - PDF)
Presentation: What ever happened to the IMI2 proposal?
English (EN) (249.95 KB - PDF)
Presentation: NICHD - Pediatric Trials Network
English (EN) (222.8 KB - PDF)
Presentation: Successful IMI project: INNODIA
English (EN) (1.47 MB - PDF)
Presentation: EPCTRI: Paediatrics in 2016. Roadmap of European Strategy Forum for Research Infrastructure (ESFRI)
English (EN) (376.33 KB - PDF)
Presentation: How can the informed consent process better address the needs of parents/children?
English (EN) (190.81 KB - PDF)
Presentation: The EU Clinical Trial Regulation and children and young people (minors) - Ethical and procedural issues
English (EN) (77.12 KB - PDF)
Presentation: Networking of European REC's
English (EN) (149.18 KB - PDF)
Presentation: Paediatric specific and ethics issues related to implementation of Clinical Trial Regulation
English (EN) (100.95 KB - PDF)
Presentation: Ethical considerations for clinical trials on medicinal products conducted with the paediatric population
English (EN) (366.86 KB - PDF)
Presentation: Involvement of children - iCAN
English (EN) (4.33 MB - PDF)
Presentation: Update from EMA Workshop on extrapolation of efficacy in children
English (EN) (102.9 KB - PDF)
Presentation: Improving new drug development for children and adolescents: The ACCELERATE initiative
English (EN) (1.61 MB - PDF)
Presentation - PDCO perspectives & proposals - Enpr-EMA coordinating group
English (EN) (125.66 KB - PDF)
Presentation: Severe Paediatric Asthma Collaborative in Europe (SPACE)
English (EN) (145.54 KB - PDF)
Presentation: Update on new Enpr-EMA Paediatric Antibiotic Clinical Trial Working Group
English (EN) (139.57 KB - PDF)
Related information
- Promoting high-quality clinical research to develop more and better medicines for children (14/04/2016)
- European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
- 2017 Enpr-EMA workshop will take place on 16 May 2017