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

• 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

Reference Number: EMA/408587/2016

Minutes of the 2016 annual face to face meeting of the Enpr-EMA Coordinating Group members - 3 June 2016

Reference Number: EMA/403089/2016Summary:

Minutes of the 2016 annual face to face meeting of the Enpr-EMA Coordinating Group members

Presentation - Update on the IMI2 Proposal to Build a Sustainable pan-European Paediatric Clinical Trials Network (William R Treem)

Summary:

Update on the IMI2 Proposal to Build a Sustainable pan-European Paediatric Clinical Trials Network, on behalf of the EFPIA Consortium - William R Treem

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

AdoptedReference Number: EMA/795122/2015

Agenda: 2016 annual meeting of Enpr-EMA members

Agenda: 2016 annual face to face meeting of the Enpr-EMA Coordinating Group members

Reference Number: EMA/204746/2016

Presentation: Report from the coordinating group (CG) Update on Enpr-EMA activities, achievements and challenges

Presentation: Dialogue and interaction with ethics committees

Presentation: Standard Operating Procedure for meetings about generic issues in paediatric drug development convened by Enpr-EMA

Presentation: Educational Training of Research Staff Involved in Paediatric Clinical Trials / GCP Training across multispecialty and countries

Presentation: Working Group on public-private partnership

Presentation: Young Persons Advisory Groups Terms of Reference and updated Work Plan

Presentation: OKIDS activity update, learnings and improvements

Presentation: What ever happened to the IMI2 proposal?

Presentation: NICHD - Pediatric Trials Network

Presentation: Successful IMI project: INNODIA

Presentation: EPCTRI: Paediatrics in 2016. Roadmap of European Strategy Forum for Research Infrastructure (ESFRI)

Presentation: How can the informed consent process better address the needs of parents/children?

Presentation: The EU Clinical Trial Regulation and children and young people (minors) - Ethical and procedural issues

Presentation: Networking of European REC's

Presentation: Paediatric specific and ethics issues related to implementation of Clinical Trial Regulation

Presentation: Ethical considerations for clinical trials on medicinal products conducted with the paediatric population

Presentation: Involvement of children - iCAN

Presentation: Update from EMA Workshop on extrapolation of efficacy in children

Presentation: Improving new drug development for children and adolescents: The ACCELERATE initiative

Presentation - PDCO perspectives & proposals - Enpr-EMA coordinating group

Presentation: Severe Paediatric Asthma Collaborative in Europe (SPACE)

Presentation: Update on new Enpr-EMA Paediatric Antibiotic Clinical Trial Working Group